Trial Outcomes & Findings for Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes (NCT NCT00859898)
NCT ID: NCT00859898
Last Updated: 2016-07-07
Results Overview
Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. 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.
COMPLETED
PHASE3
1093 participants
Week 24
2016-07-07
Participant Flow
Participants were recruited from 13-April-2009 to 26-November-2009. Study completed 12-May-2010. Drug naive participants with Type 2 Diabetes Mellitus who had inadequate glycemic control with diet and exercise. Inadequate glycemic control was defined as a hemoglobin A1c (HbA1c) ≥ 7.5% and ≤ 12.0%.
Qualification: 660 completed: 28 administrative, 373 no longer met criteria, 1 lack of efficacy, 26 withdrew consent, 1 lost to follow up (LTF), 4 other. Lead-In: 649 entered; 641 completed/ randomized: 1 adverse event, 1 administrative, 4 no longer met criteria, 1 withdrew consent, 1 LTF. Treated 638: 1 LTF, 1 non-compliance, 1 withdrew consent.
Participant milestones
| Measure |
Dapagliflozin + Metformin XR
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.
Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
211
|
219
|
208
|
|
Overall Study
COMPLETED
|
183
|
188
|
181
|
|
Overall Study
NOT COMPLETED
|
28
|
31
|
27
|
Reasons for withdrawal
| Measure |
Dapagliflozin + Metformin XR
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.
Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
4
|
9
|
8
|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
11
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
5
|
|
Overall Study
poor/non-compliance
|
2
|
0
|
0
|
|
Overall Study
No longer meets criteria
|
0
|
1
|
0
|
|
Overall Study
non-specified
|
1
|
1
|
1
|
Baseline Characteristics
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Dapagliflozin + Metformin XR
n=211 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=219 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=208 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
Total
n=638 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 10.13 • n=113 Participants
|
51.1 years
STANDARD_DEVIATION 11.53 • n=163 Participants
|
52.7 years
STANDARD_DEVIATION 10.38 • n=160 Participants
|
51.6 years
STANDARD_DEVIATION 10.72 • n=483 Participants
|
|
Age, Customized
Less than (<) 65 years
|
190 participants
n=113 Participants
|
192 participants
n=163 Participants
|
181 participants
n=160 Participants
|
563 participants
n=483 Participants
|
|
Age, Customized
Greater than, equal to (>=) 65 and < 75 years
|
21 participants
n=113 Participants
|
24 participants
n=163 Participants
|
25 participants
n=160 Participants
|
70 participants
n=483 Participants
|
|
Age, Customized
>= 75 years
|
0 participants
n=113 Participants
|
3 participants
n=163 Participants
|
2 participants
n=160 Participants
|
5 participants
n=483 Participants
|
|
Age, Customized
Not Reported
|
0 participants
n=113 Participants
|
0 participants
n=163 Participants
|
0 participants
n=160 Participants
|
0 participants
n=483 Participants
|
|
Age, Customized
Female <= 50 years
|
43 participants
n=113 Participants
|
44 participants
n=163 Participants
|
44 participants
n=160 Participants
|
131 participants
n=483 Participants
|
|
Age, Customized
Female > 50 years
|
62 participants
n=113 Participants
|
70 participants
n=163 Participants
|
67 participants
n=160 Participants
|
199 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=113 Participants
|
114 Participants
n=163 Participants
|
111 Participants
n=160 Participants
|
330 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=113 Participants
|
105 Participants
n=163 Participants
|
97 Participants
n=160 Participants
|
308 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=113 Participants
|
34 Participants
n=163 Participants
|
35 Participants
n=160 Participants
|
103 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=113 Participants
|
63 Participants
n=163 Participants
|
54 Participants
n=160 Participants
|
171 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
123 Participants
n=113 Participants
|
122 Participants
n=163 Participants
|
119 Participants
n=160 Participants
|
364 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
174 participants
n=113 Participants
|
176 participants
n=163 Participants
|
166 participants
n=160 Participants
|
516 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
11 participants
n=113 Participants
|
13 participants
n=163 Participants
|
8 participants
n=160 Participants
|
32 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 participants
n=113 Participants
|
27 participants
n=163 Participants
|
31 participants
n=160 Participants
|
82 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
2 participants
n=113 Participants
|
3 participants
n=163 Participants
|
3 participants
n=160 Participants
|
8 participants
n=483 Participants
|
|
Body Mass Index
< 25 kg/m^2
|
20 participants
n=113 Participants
|
25 participants
n=163 Participants
|
21 participants
n=160 Participants
|
66 participants
n=483 Participants
|
|
Body Mass Index
>= 25 kg/m^2 - <27 kg/m^2
|
23 participants
n=113 Participants
|
24 participants
n=163 Participants
|
20 participants
n=160 Participants
|
67 participants
n=483 Participants
|
|
Body Mass Index
>= 27 kg/m^2 - <30 kg/m^2
|
45 participants
n=113 Participants
|
39 participants
n=163 Participants
|
49 participants
n=160 Participants
|
133 participants
n=483 Participants
|
|
Body Mass Index
>= 30 kg/m^2
|
123 participants
n=113 Participants
|
131 participants
n=163 Participants
|
118 participants
n=160 Participants
|
372 participants
n=483 Participants
|
|
Waist Circumference
|
104.33 cm
STANDARD_DEVIATION 13.678 • n=113 Participants
|
103.86 cm
STANDARD_DEVIATION 12.805 • n=163 Participants
|
103.03 cm
STANDARD_DEVIATION 13.224 • n=160 Participants
|
103.75 cm
STANDARD_DEVIATION 13.225 • n=483 Participants
|
|
Hemoglobin A1c
|
9.09 percent of hemoglobin
STANDARD_DEVIATION 1.258 • n=113 Participants
|
9.05 percent of hemoglobin
STANDARD_DEVIATION 1.279 • n=163 Participants
|
9.05 percent of hemoglobin
STANDARD_DEVIATION 1.308 • n=160 Participants
|
9.06 percent of hemoglobin
STANDARD_DEVIATION 1.280 • n=483 Participants
|
|
Total Body Weight
|
88.43 kg
STANDARD_DEVIATION 19.668 • n=113 Participants
|
88.53 kg
STANDARD_DEVIATION 19.334 • n=163 Participants
|
87.24 kg
STANDARD_DEVIATION 19.423 • n=160 Participants
|
88.08 kg
STANDARD_DEVIATION 19.452 • n=483 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non-missing baseline and Week 24 (LOCF) values.
Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. 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 + Metformin XR
n=202 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=216 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=203 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants
|
-1.98 Percent of hemoglobin
Standard Error 0.0759
|
-1.45 Percent of hemoglobin
Standard Error 0.0734
|
-1.44 Percent of hemoglobin
Standard Error 0.0757
|
SECONDARY outcome
Timeframe: Week 24Population: Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Data after rescue medication was excluded from this analysis. FPG 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 of the Double-Blind Period.
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=209 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=216 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=207 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants
|
-60.4 mg/dL
Standard Error 2.533
|
-46.4 mg/dL
Standard Error 2.494
|
-34.8 mg/dL
Standard Error 2.545
|
SECONDARY outcome
Timeframe: Week 24Population: N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values; N=202, 216, 203, respectively. n=number of responders: 92, 69, 72, respectively. n/N=percent. Percent is then adjusted for baseline HbA1c.
Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (\<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=202 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=216 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=203 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants
|
46.6 Percent of participants
Interval 40.1 to 53.0
|
31.7 Percent of participants
Interval 25.7 to 37.7
|
35.5 Percent of participants
Interval 28.8 to 41.7
|
SECONDARY outcome
Timeframe: Week 24Population: N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values, whose baseline HbA1c was \>=9.0%.
HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (\>=) 9.0%. 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 |
Dapagliflozin + Metformin XR
n=106 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=97 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=95 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%
|
-2.59 Percent of Hemoglobin
Standard Error 0.1249
|
-2.14 Percent of Hemoglobin
Standard Error 0.1305
|
-2.05 Percent of Hemoglobin
Standard Error 0.1318
|
SECONDARY outcome
Timeframe: Week 24Population: N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline 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 was measured in kilograms (kg). 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 + Metformin XR
n=209 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=219 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=208 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants
|
-3.33 kg
Standard Error 0.2401
|
-2.73 kg
Standard Error 0.2346
|
-1.36 kg
Standard Error 0.2408
|
SECONDARY outcome
Timeframe: Day 1 of Double Blind Period to end of Week 24 Plus 30 daysPopulation: Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.
Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 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. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included.
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=211 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=219 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=208 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Related SAE
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Discontinued due to AE
|
4 participants
|
9 participants
|
8 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Deaths
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Adverse Event (AE)
|
126 participants
|
132 participants
|
118 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Related Adverse Event
|
34 participants
|
47 participants
|
32 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Serious Adverse Event (SAE)
|
3 participants
|
5 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Discontinued due to SAE
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to last dose plus 4 days in 12 Week Double Blind PeriodPopulation: Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs except hypoglycemia, which excluded data after rescue.
Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value \< 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement \< 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose \< 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=211 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=219 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=208 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs of Fracture
|
2 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Cardiac Disorder AEs
|
3 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Vascular Disorder AEs
|
4 participants
|
10 participants
|
8 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Hypoglycemia AEs (excluding data after rescue)
|
7 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Hypoglycemia Major Episode
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Hypoglycemia Minor Episode
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Hypoglycemia Other Episode
|
6 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs Suggestive of Genital Infection
|
18 participants
|
28 participants
|
5 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs Suggestive of UTI
|
16 participants
|
24 participants
|
9 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs of Renal Impairment or Failure
|
2 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs of Hypotension
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs of Syncope
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AEs of Urinary Stones
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 24Population: N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.
Measurements were taken 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. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. 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 |
Dapagliflozin + Metformin XR
n=182 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=185 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=179 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants
Diastolic (N=182, 185, 179)
|
-1.8 mmHg
Standard Error 0.579
|
-1.9 mmHg
Standard Error 0.525
|
0.0 mmHg
Standard Error 0.606
|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants
Systolic (N=182, 185, 179)
|
-3.3 mmHg
Standard Error 0.947
|
-4.0 mmHg
Standard Error 0.883
|
-1.2 mmHg
Standard Error 1.010
|
SECONDARY outcome
Timeframe: Week 24Population: N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.
Measurements were taken 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. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. 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 |
Dapagliflozin + Metformin XR
n=182 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=185 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=179 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants
|
0.6 bpm
Standard Error 0.607
|
-0.1 bpm
Standard Error 0.593
|
0.5 bpm
Standard Error 0.594
|
SECONDARY outcome
Timeframe: Week 2412-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included.
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=211 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=219 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=208 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Not Reported at BL, Abnormal at Week 24
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Normal at BL, Normal at Week 24 (N=211, 219, 208)
|
101 participants
|
107 participants
|
94 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Abnormal BL, Normal at Week 24 (N=211, 219, 208)
|
15 participants
|
13 participants
|
22 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Normal BL, Abnormal at Week 24 (N=211, 219, 208)
|
18 participants
|
8 participants
|
9 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Abnormal BL, Abnormal at Week 24 (N=211, 219, 208)
|
53 participants
|
68 participants
|
59 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Normal at BL, Not Reported at Week 24
|
19 participants
|
15 participants
|
15 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
Abnormal at BL, Not Reported at Week 24
|
5 participants
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24/end of treatment plus 4 daysPopulation: N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.
Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin \<6 (\>18 females or \>20 males) g/dL; hematocrit \<20% ( \>55% females or \>60% males); creatinine (\>=1.5\*preRX, \>=2.5 mg/dL); glucose \<54 (\>350) mg/dL; creatine kinase (\>5\*ULN);calcium \<7.5 (\>=1 mg/dL from ULN and \>= 0.5mg/dL from PreRX); sodium \<130 or \< 120 male/female (\>150 mEq/L; potassium \<=2.5 (\>=6.0) mEq/L; bicarbonate \<= 13 mEq/L; inorganic phosphorus: \<=1.8 if age 17-65 or \<=2.1 if age \>=66, (\>=5.6 if age 17-65 or \>=5.1) mg/dL if age \>=66; albumin \<=2 (\>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (\>1800 mg/g)
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=209 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=218 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=207 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Bicarbonate Low <=13mEq/L (N=209, 218, 207)
|
3 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Urine albumin/creat ratio (high)(N=209, 218, 206)
|
0 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Hematocrit High > 55% (N=209, 218, 206)
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Hemoglobin High >18 g/dL(N=209, 218, 207)
|
5 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Creatinine >1.5*PreRX (N=209, 218, 207)
|
8 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Glucose High > 350 mg/dL (N=209, 218, 207)
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Albumin low or high (N=209, 218, 207)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Calcium Low <7.5mg/dL (N=209, 218, 207)
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Calcium High >=1mg/dL+ULN (N=209, 218, 207)
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Potassium High >=6 mEq/L (N=209, 218, 207)
|
2 participants
|
3 participants
|
6 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Sodium Low <130 mEq/L (N=209, 218, 207)
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Sodium High >150 mEq/L (N=209, 218, 207)
|
5 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Sodium Low <120 mEq/L (N=209, 218, 207)
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
inorganic phosphorus (high)(N=209, 218, 207)
|
7 participants
|
13 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24/end of treatment plus 30 daysSafety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (\>) less than (\<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (\>3\*ULN); bilirubin (\>2\*ULN if PreRX \<= ULN; \>3\*ULN if PreRX \> ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT \>3\*ULN and bilirubin \>1.5\*ULN within 14 days on or after ALT elevation.
Outcome measures
| Measure |
Dapagliflozin + Metformin XR
n=210 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Dapagliflozin
n=219 Participants
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Metformin XR
n=208 Participants
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
AST >3*ULN (N=210, 219, 208)
|
2 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
AST >5*ULN (N=210, 219, 208)
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
ALT >3*ULN (N=210, 219, 208)
|
2 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
ALT >5*ULN (N=210, 219, 208)
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
ALT >10*ULN (N=210, 219, 208)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
AST or ALT > 3*ULN (N=210, 219, 208)
|
3 participants
|
5 participants
|
7 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
AST or ALT > 5*ULN (N=210, 219, 208)
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
AST or ALT > 10*ULN (N=210, 219, 208)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
Total bilirubin >1.5*ULN (N=210, 219, 207)
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
AST or ALT + Bilirubin (High) (N=210, 219, 208)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
ALP >1.5*ULN (N=210, 219, 208)
|
5 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
ALP >3*ULN (N=210, 219, 208)
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Dapagliflozin
Dapagliflozin + Metformin XR
Metformin XR
Serious adverse events
| Measure |
Dapagliflozin
n=219 participants at risk
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Dapagliflozin + Metformin XR
n=211 participants at risk
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Metformin XR
n=208 participants at risk
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Infections and infestations
Lung abscess
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.47%
1/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.47%
1/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.48%
1/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.96%
2/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Reproductive system and breast disorders
Rectocele
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.48%
1/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.47%
1/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
General disorders
Pain
|
0.00%
0/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.48%
1/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Pneumonia
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Urosepsis
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Gastrointestinal disorders
Proctalgia
|
0.46%
1/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
Other adverse events
| Measure |
Dapagliflozin
n=219 participants at risk
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
|
Dapagliflozin + Metformin XR
n=211 participants at risk
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
|
Metformin XR
n=208 participants at risk
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
6/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
7.1%
15/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
9.6%
20/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
17/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
2.8%
6/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.9%
4/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.0%
11/219 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
3.3%
7/211 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.48%
1/208 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
Additional Information
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