Trial Outcomes & Findings for An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets (NCT NCT00643851)
NCT ID: NCT00643851
Last Updated: 2023-01-30
Results Overview
HbA1c was measured as percent of hemoglobin 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
994 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2023-01-30
Participant Flow
Of 994 participants enrolled, 632 completed a qualification period. Of these 632 participants, 603 were randomized. Of these 603 randomized, 598 received at least one dose of study medication treatment. Of these 598 randomized, 518 completed double-blind treatment period.
Participant milestones
| Measure |
Dapagliflozin 5 mg + Metformin XR
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
194
|
203
|
201
|
|
Overall Study
COMPLETED
|
177
|
170
|
171
|
|
Overall Study
NOT COMPLETED
|
17
|
33
|
30
|
Reasons for withdrawal
| Measure |
Dapagliflozin 5 mg + Metformin XR
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
8
|
15
|
9
|
|
Overall Study
Non-compl., not met criteria, etc.
|
3
|
4
|
6
|
Baseline Characteristics
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Baseline characteristics by cohort
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=194 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=203 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=201 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.7 Years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
52.3 Years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
51.8 Years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
52.0 Years
STANDARD_DEVIATION 9.77 • n=4 Participants
|
|
Age, Customized
Younger than 65 years
|
177 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
544 Participants
n=4 Participants
|
|
Age, Customized
65 to younger than 75 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Customized
75 years and older
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
78 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
116 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
153 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
477 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)
HbA1c was measured as percent of hemoglobin 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=185 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=196 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=195 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
|
-2.05 % of hemoglobin
Standard Error 0.0892
|
-1.19 % of hemoglobin
Standard Error 0.0866
|
-1.35 % of hemoglobin
Standard Error 0.0868
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=192 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=203 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=200 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
|
-61.0 mg/dL
Standard Error 2.783
|
-42.0 mg/dL
Standard Error 2.708
|
-33.6 mg/dL
Standard Error 2.728
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.
Outcome measures
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=185 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=196 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=195 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
|
52.4 Percentage of participants
Standard Error 3.581
|
22.5 Percentage of participants
Standard Error 2.741
|
34.6 Percentage of participants
Standard Error 3.296
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with baseline HbA1c ≥ 9%
HbA1c was measured as percent of hemoglobin 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=92 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=96 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=101 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])
|
-3.01 % of hemoglobin
Standard Error 0.1381
|
-1.67 % of hemoglobin
Standard Error 0.1361
|
-1.82 % of hemoglobin
Standard Error 0.1320
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)
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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=192 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=203 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=200 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
|
-2.66 kg
Standard Error 0.2428
|
-2.61 kg
Standard Error 0.2361
|
-1.29 kg
Standard Error 0.2378
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with BMI ≥ 27 kg/m2
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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=142 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=156 Participants
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=154 Participants
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
|
-3.04 kg
Standard Error 0.3031
|
-2.88 kg
Standard Error 0.2890
|
-1.47 kg
Standard Error 0.2907
|
Adverse Events
Dapagliflozin 5 mg + Metformin XR
Serious events: 6 serious events
Other events: 48 other events
Deaths: 0 deaths
Dapagliflozin 5 mg
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
Metformin XR
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=194 participants at risk
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=203 participants at risk
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=201 participants at risk
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
1.5%
3/194 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
HERPES ZOSTER
|
0.52%
1/194 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
PNEUMONIA
|
0.52%
1/194 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
GANGRENE
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.52%
1/194 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Injury, poisoning and procedural complications
GUN SHOT WOUND
|
0.52%
1/194 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.99%
2/203 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.49%
1/203 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/201 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Nervous system disorders
ISCHAEMIC NEUROPATHY
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/194 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/203 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.50%
1/201 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Other adverse events
| Measure |
Dapagliflozin 5 mg + Metformin XR
n=194 participants at risk
Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
|
Dapagliflozin 5 mg
n=203 participants at risk
Dapagliflozin tablets, oral, once daily for 24 weeks
|
Metformin XR
n=201 participants at risk
Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
7.7%
15/194 • Number of events 20 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
3.9%
8/203 • Number of events 9 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
7.0%
14/201 • Number of events 21 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
NAUSEA
|
5.7%
11/194 • Number of events 20 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
2.0%
4/203 • Number of events 5 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.0%
8/201 • Number of events 14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.2%
10/194 • Number of events 11 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.9%
10/203 • Number of events 11 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
5.5%
11/201 • Number of events 11 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.2%
10/194 • Number of events 11 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.4%
9/203 • Number of events 9 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
5.0%
10/201 • Number of events 12 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
4.6%
9/194 • Number of events 9 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
5.4%
11/203 • Number of events 13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.0%
8/201 • Number of events 8 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place