Trial Outcomes & Findings for A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise (NCT NCT00528372)

NCT ID: NCT00528372

Last Updated: 2015-10-20

Results Overview

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1067 participants
• Primary outcome timeframe: Baseline to Week 24 (end of Short-term Period)
• Results posted on: 2015-10-20

Participant Flow

Of 1067 participants enrolled, 558 received treatment in the Short-term Period. Of those 558 participants, 469 entered the Long-term Period.

Participant milestones

Measure	Group 1: Dapagliflozin Placebo Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 2.5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Short-term (ST) Period (Day 1-Week 24) STARTED	75	65	64	70	67	68	76	34	39
Short-term (ST) Period (Day 1-Week 24) COMPLETED	63	60	52	57	58	57	65	28	34
Short-term (ST) Period (Day 1-Week 24) NOT COMPLETED	12	5	12	13	9	11	11	6	5
Long-term (LT) Period (Weeks 24-102) STARTED	62	59	51	56	58	57	65	28	33
Long-term (LT) Period (Weeks 24-102) COMPLETED	42	40	43	42	37	42	48	22	27
Long-term (LT) Period (Weeks 24-102) NOT COMPLETED	20	19	8	14	21	15	17	6	6

Reasons for withdrawal

Measure	Group 1: Dapagliflozin Placebo Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 2.5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Short-term (ST) Period (Day 1-Week 24) Lack of Efficacy	2	0	0	0	0	0	0	0	0
Short-term (ST) Period (Day 1-Week 24) Adverse Event	0	2	2	6	0	3	3	0	0
Short-term (ST) Period (Day 1-Week 24) Withdrawal by Subject	1	2	7	1	6	4	6	2	4
Short-term (ST) Period (Day 1-Week 24) Lost to Follow-up	5	1	2	3	3	2	2	3	1
Short-term (ST) Period (Day 1-Week 24) Poor or noncompliance	0	0	0	2	0	1	0	0	0
Short-term (ST) Period (Day 1-Week 24) Administration reason by sponsor	1	0	1	0	0	1	0	0	0
Short-term (ST) Period (Day 1-Week 24) Other	3	0	0	1	0	0	0	1	0
Long-term (LT) Period (Weeks 24-102) Lack of Efficacy	6	6	1	7	7	7	2	0	0
Long-term (LT) Period (Weeks 24-102) Adverse Event	3	1	1	0	2	3	4	0	0
Long-term (LT) Period (Weeks 24-102) Withdrawal by Subject	6	6	3	3	7	0	4	2	4
Long-term (LT) Period (Weeks 24-102) Lost to Follow-up	3	2	1	1	0	4	2	3	1
Long-term (LT) Period (Weeks 24-102) Poor compliance or noncompliance	0	1	1	1	0	0	1	0	0
Long-term (LT) Period (Weeks 24-102) No longer met study criteria	0	0	0	0	2	1	0	0	0
Long-term (LT) Period (Weeks 24-102) Administrative reason by sponsor	0	1	0	0	0	0	1	0	1
Long-term (LT) Period (Weeks 24-102) Other	2	2	1	2	3	0	3	1	0

Baseline Characteristics

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Baseline characteristics by cohort

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 Participants Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg PM n=68 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg PM n=76 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 2: Dapagliflozin, 5 mg AM n=34 Participants Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 2: Dapagliflozin, 10 mg AM n=39 Participants Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Total n=558 Participants Total of all reporting groups
Age, Customized <65 years	66 Participants n=5 Participants	54 Participants n=7 Participants	54 Participants n=5 Participants	66 Participants n=4 Participants	52 Participants n=21 Participants	53 Participants n=10 Participants	72 Participants n=115 Participants	34 Participants n=24 Participants	36 Participants n=42 Participants	487 Participants n=42 Participants
Age, Customized ≥65 and <75	8 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants	12 Participants n=10 Participants	4 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	66 Participants n=42 Participants
Age, Customized ≥75	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	29 Participants n=7 Participants	33 Participants n=5 Participants	36 Participants n=4 Participants	38 Participants n=21 Participants	39 Participants n=10 Participants	37 Participants n=115 Participants	10 Participants n=24 Participants	16 Participants n=42 Participants	282 Participants n=42 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	36 Participants n=7 Participants	31 Participants n=5 Participants	34 Participants n=4 Participants	29 Participants n=21 Participants	29 Participants n=10 Participants	39 Participants n=115 Participants	24 Participants n=24 Participants	23 Participants n=42 Participants	276 Participants n=42 Participants
Race/Ethnicity, Customized White	71 Participants n=5 Participants	63 Participants n=7 Participants	61 Participants n=5 Participants	63 Participants n=4 Participants	65 Participants n=21 Participants	65 Participants n=10 Participants	72 Participants n=115 Participants	31 Participants n=24 Participants	38 Participants n=42 Participants	529 Participants n=42 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	10 Participants n=42 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	12 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islanders	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 LOCF values

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=72 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=64 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=61 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=62 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=63 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=73 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.23 Percent Standard Error 0.1044	-0.58 Percent Standard Error 0.1107	-0.77 Percent Standard Error 0.1134	-0.89 Percent Standard Error 0.1099	-0.83 Percent Standard Error 0.1125	-0.79 Percent Standard Error 0.1117	-0.79 Percent Standard Error 0.1037	—	—

PRIMARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=25 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=32 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2	-2.88 Percent Standard Deviation 1.406	-2.66 Percent Standard Deviation 1.261	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 LOCF values

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=66 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=73 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-4.1 mg/dL Standard Error 3.906	-15.2 mg/dL Standard Error 4.196	-24.1 mg/dL Standard Error 4.298	-28.8 mg/dL Standard Error 4.046	-25.6 mg/dL Standard Error 4.132	-27.3 mg/dL Standard Error 4.170	-29.6 mg/dL Standard Error 3.964	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values

Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=25 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=32 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2	-77. mg/dL Standard Deviation 53.39	-84.3 mg/dL Standard Deviation 61.01	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 values

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=62 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=69 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=66 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=74 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-2.19 Kilograms Standard Error 0.4297	-3.25 Kilograms Standard Error 0.4615	-2.83 Kilograms Standard Error 0.4731	-3.16 Kilograms Standard Error 0.4493	-3.82 Kilograms Standard Error 0.4548	-3.55 Kilograms Standard Error 0.4582	-3.05 Kilograms Standard Error 0.4329	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment nonmissing baseline and Week 24 LOCF values.

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=34 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=37 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2	-2.06 Kilograms Standard Deviation 3.437	-1.90 Kilograms Standard Deviation 3.539	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 1 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 LOCF values

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=71 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=57 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=56 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=48 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=54 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=60 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-2.4 mg/dL Standard Error 2.885	-2.9 mg/dL Standard Error 3.219	-16.4 mg/dL Standard Error 3.248	-16.1 mg/dL Standard Error 3.016	-14.4 mg/dL Standard Error 3.086	-18.6 mg/dL Standard Error 3.219	-20.3 mg/dL Standard Error 3.088	—	—

SECONDARY outcome

Timeframe: Baseline to Week 1

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment with nonmissing baseline and Week 24 LOCF values

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=34 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=37 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2	-54.3 mg/dL Standard Deviation 41.9	-74.3 mg/dL Standard Deviation 51.09	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants who had nonmissing baseline and Week 24 LOCF values

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=72 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=64 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=61 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=62 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=63 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=73 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	31.6 Percentage of participants	41.3 Percentage of participants	44.2 Percentage of participants	50.8 Percentage of participants	51.4 Percentage of participants	44.0 Percentage of participants	51.6 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week24 LOCF values.

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=5 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=8 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=9 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=14 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=11 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=8 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=12 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	0.19 Percent Standard Error 0.5473	-1.26 Percent Standard Error 0.4327	-2.00 Percent Standard Error 0.4079	-2.04 Percent Standard Error 0.3307	-1.35 Percent Standard Error 0.3710	-1.53 Percent Standard Error 0.4416	-1.21 Percent Standard Error 0.3643	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with baseline BMI ≥27 kg/m\^2 and nonmissing baseline and Week 24 LOCF values

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=58 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=53 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=53 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=59 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=48 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=54 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=60 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.21 Percent Standard Error 0.1210	-0.58 Percent Standard Error 0.1265	-0.73 Percent Standard Error 0.1267	-0.88 Percent Standard Error 0.1201	-0.81 Percent Standard Error 0.1329	-0.76 Percent Standard Error 0.1255	-0.80 Percent Standard Error 0.1194	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c values at both baseline and Week 24 (LOCF)

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=11 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=17 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=17 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=14 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=62 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=63 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=73 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	14.5 Percentage of participants	27.2 Percentage of participants	26.6 Percentage of participants	23.1 Percentage of participants	33.4 Percentage of participants	25.8 Percentage of participants	26.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with baseline BMI ≥27 kg/m\^2 and nonmissing baseline and Week 24 values

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=60 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=54 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=54 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=63 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=53 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=57 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=61 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-2.43 Kilograms Standard Error 0.5063	-3.43 Kilograms Standard Error 0.5341	-2.91 Kilograms Standard Error 0.5357	-3.39 Kilograms Standard Error 0.4945	-4.30 Kilograms Standard Error 0.5388	-3.70 Kilograms Standard Error 0.5199	-3.39 Kilograms Standard Error 0.5027	—	—

SECONDARY outcome

Timeframe: Day 1 to Week 102 (end of Long-term Period) + 30 days

Population: Randomized participants who received at least 1 dose of study medication

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=68 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=76 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM n=34 Participants Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM n=39 Participants Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) AE leading to discontinuation	4 Participants	4 Participants	4 Participants	5 Participants	2 Participants	6 Participants	7 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) Hypoglycemia leading to discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) >=1 AE	58 Participants	48 Participants	43 Participants	56 Participants	50 Participants	50 Participants	54 Participants	29 Participants	33 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) >=1 Hypoglycemia	4 Participants	3 Participants	0 Participants	3 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) >=1 Related AEs	15 Participants	13 Participants	10 Participants	17 Participants	19 Participants	18 Participants	21 Participants	12 Participants	10 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) Deaths	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) SAEs	5 Participants	6 Participants	4 Participants	1 Participants	7 Participants	5 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) >=1 related SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) SAEs leading to discontinuation	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 102 (end of Long-term Period)

Population: Randomized participants who received at least 1 dose of study medication and with laboratory test results available

Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=62 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=66 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=73 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM n=34 Participants Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM n=39 Participants Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Calcium, total (<7.5 mg/dL)	3 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Bicarbonate (<=13 mEq/L)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Potassium, serum (>=6 mEqL)	3 Participants	1 Participants	1 Participants	2 Participants	4 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Hemoglobin (>18 g/dL)	0 Participants	3 Participants	2 Participants	4 Participants	2 Participants	1 Participants	6 Participants	3 Participants	5 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Creatine kinase (>10*ULN)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Albumin/creatinine ratio (>1800 mg/g)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Hematocrit (>55%)	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	1 Participants	4 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Hematocrit (>60%)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Glucose ( >350 mg/dL)	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Glucose (<54 mg/dL)	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Creatine kinase (>5*ULN)	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Sodium, serum (<130 mEq/L)	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Sodium, serum (>150 mEq/L)	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Phosphorus, inorganic (high)	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) Creatinine (>=1.5 preRX creatinine)	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 to Week 102 (end of Long-term Period)

Population: Randomized participants who received at least 1 dose of study medication and with laboratory test results available

Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=68 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=76 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	0 Participants	1 Participants	1 Participants	0 Participants	5 Participants	1 Participants	4 Participants	—	—
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	—	—
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	4 Participants	3 Participants	1 Participants	1 Participants	4 Participants	3 Participants	2 Participants	—	—
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	—	—
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants who received at least 1 dose of study medication and who had measurements available

12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Outcome measures

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 Participants Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 5 mg PM n=68 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 1: Dapagliflozin, 10 mg PM n=76 Participants Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.	Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Normal/Week 24: Normal	38 Participants	36 Participants	32 Participants	31 Participants	33 Participants	33 Participants	35 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Normal/Week 24: Abnormal	6 Participants	3 Participants	5 Participants	1 Participants	3 Participants	6 Participants	10 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Normal/Week 24: Not reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Abnormal/Week 24: Abnormal	18 Participants	17 Participants	11 Participants	17 Participants	17 Participants	14 Participants	11 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Abnormal/Week 24: Not reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Not reported/Week 24: Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Basline: Not reported/Week 24: Abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Not reported/Week 24: Not reported	8 Participants	7 Participants	13 Participants	15 Participants	10 Participants	11 Participants	10 Participants	—	—
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) Baseline: Abnormal/Week 24: Normal	5 Participants	2 Participants	3 Participants	6 Participants	4 Participants	4 Participants	10 Participants	—	—

Adverse Events

Group 1: Dapagliflozin Placebo AM & PM

Serious events: 5 serious events

Other events: 40 other events

Deaths: 0 deaths

Group 1: Dapagliflozin, 2.5 mg AM

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Group 1: Dapagliflozin, 5 mg AM

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Group 1: Dapagliflozin, 10 mg AM

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Group 1: Dapagliflozin, 2.5 mg PM

Serious events: 7 serious events

Other events: 38 other events

Deaths: 0 deaths

Group 1: Dapagliflozin, 5 mg PM

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Group 1: Dapagliflozin, 10 mg PM

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 participants at risk Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 participants at risk Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg PM n=68 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg PM n=76 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
Cardiac disorders Cardiac failure	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Vascular disorders Femoral artery occlusion	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Pneumonia	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Renal and urinary disorders Renal failure acute	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Ear and labyrinth disorders Vertigo	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Investigations Albumin urine present	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Influenza	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Vascular disorders Venous thrombosis	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Renal and urinary disorders Glomerulonephritis acute	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Renal and urinary disorders Malacoplakia vesicae	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
General disorders Adverse drug reaction	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Nervous system disorders Cerebrovascular accident	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Pilonidal cyst	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Cardiac disorders Acute myocardial infarction	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Arthritis bacterial	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Staphylococcal infection	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Cardiac disorders Acute coronary syndrome	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Investigations Urine albumin/creatinine ratio increased	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Cardiac disorders Angina pectoris	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.9% 2/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Cardiac disorders Atrial fibrillation	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
General disorders Chest pain	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Injury, poisoning and procedural complications Contusion	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Abdominal hernia	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Cardiac disorders Mitral valve incompetence	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Other adverse events

Measure	Group 1: Dapagliflozin Placebo AM & PM n=75 participants at risk Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg AM n=65 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg AM n=64 participants at risk Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg AM n=70 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 2.5 mg PM n=67 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 5 mg PM n=68 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	Group 1: Dapagliflozin, 10 mg PM n=76 participants at risk Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
Infections and infestations Bronchitis	6.7% 5/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.7% 4/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.5% 5/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.9% 4/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Constipation	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.0% 4/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.9% 2/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.6% 2/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Diarrhoea	6.7% 5/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.2% 6/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.7% 4/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.0% 4/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	10.3% 7/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.9% 6/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Influenza	4.0% 3/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	10.8% 7/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.8% 5/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.1% 5/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	8.8% 6/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.6% 5/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Pharyngitis	8.0% 6/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.4% 6/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.1% 5/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.0% 6/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Upper respiratory tract infection	5.3% 4/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.1% 5/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.5% 3/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.9% 2/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	11.8% 9/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Abdominal pain	2.7% 2/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.0% 6/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.9% 4/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.6% 2/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Musculoskeletal and connective tissue disorders Back pain	6.7% 5/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.6% 3/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.1% 5/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	8.8% 6/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.2% 7/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Nervous system disorders Dizziness	2.7% 2/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.6% 3/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.9% 2/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.0% 6/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.9% 4/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.9% 3/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Vascular disorders Hypertension	4.0% 3/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.3% 3/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.5% 5/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.4% 3/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
General disorders Oedema peripheral	2.7% 2/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.4% 3/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.9% 6/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 4/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.7% 3/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.3% 3/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 3/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.2% 6/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.8% 5/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	8.6% 6/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.5% 3/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	11.8% 8/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.9% 6/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Musculoskeletal and connective tissue disorders Myalgia	2.7% 2/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.9% 2/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.0% 4/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.4% 3/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Nausea	1.3% 1/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.6% 3/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.7% 3/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.4% 3/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Urinary tract infection	4.0% 3/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.6% 3/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.8% 5/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.1% 5/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.0% 4/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	10.3% 7/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.6% 5/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.7% 4/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Psychiatric disorders Insomnia	2.7% 2/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Toothache	0.00% 0/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.0% 4/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.3% 1/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Gastroenteritis	4.0% 3/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.1% 2/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.6% 1/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.9% 2/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.4% 5/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	2.6% 2/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 4/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.2% 4/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.7% 3/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.3% 3/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.5% 3/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.4% 3/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.9% 3/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Gastrointestinal disorders Gastritis	4.0% 3/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.5% 1/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	0.00% 0/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	1.4% 1/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	3.0% 2/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	4.4% 3/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	5.3% 4/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Nervous system disorders Headache	12.0% 9/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.2% 6/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.8% 5/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	8.6% 6/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	6.0% 4/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	16.2% 11/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	13.2% 10/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Infections and infestations Nasopharyngitis	9.3% 7/75 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	16.9% 11/65 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	7.8% 5/64 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	14.3% 10/70 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	16.4% 11/67 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	13.2% 9/68 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.	9.2% 7/76 • Day 1 to Week 102 (end of Long-term Period) Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Additional Information

Boaz Hirshberg

AstraZeneca Pharmaceuticals

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER