Trial Outcomes & Findings for Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone (NCT NCT00683657)
NCT ID: NCT00683657
Last Updated: 2015-06-01
Results Overview
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
COMPLETED
PHASE3
93 participants
Baseline, Week 4
2015-06-01
Participant Flow
218 subjects were enrolled and 128 entered the 4-week dietary and exercise, and metformin extended release (XR) lead-in period. Thirty-five subjects did not enter treatment period (21 no longer met study criteria, 7 withdrew consent, 7 for poor protocol compliance).
Participant milestones
| Measure |
Saxagliptin 5 mg + Metformin
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
|
Overall Study
Randomized Subjects Data Set
|
46
|
47
|
|
Overall Study
COMPLETED
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Saxagliptin 5 mg + Metformin
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Subject Withdrew Consent
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
Baseline characteristics by cohort
| Measure |
Saxagliptin 5 mg + Metformin
n=46 Participants
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
n=47 Participants
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.50 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
55.77 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
55.14 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
|
Age, Customized
<65 years
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Age, Customized
>= 65 years to <75 years
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 5 mg + Metformin
n=41 Participants
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
n=44 Participants
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Baseline Mean
|
177.5 mg/dL
Standard Error 4.99
|
181.2 mg/dL
Standard Error 6.30
|
|
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Week 4 Mean
|
163.8 mg/dL
Standard Error 5.09
|
184.2 mg/dL
Standard Error 7.05
|
|
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Adjusted Mean Change from Baseline
|
-13.8 mg/dL
Standard Error 2.99
|
3.0 mg/dL
Standard Error 2.89
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.
Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 5 mg + Metformin
n=40 Participants
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
n=44 Participants
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
Baseline Mean
|
212.1 mg/dL
Standard Error 6.80
|
211.1 mg/dL
Standard Error 6.60
|
|
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
Week 4 Mean
|
181.4 mg/dL
Standard Error 6.79
|
210.8 mg/dL
Standard Error 8.02
|
|
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
Adjusted Mean Change from Baseline
|
-30.7 mg/dL
Standard Error 5.14
|
-0.4 mg/dL
Standard Error 4.90
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.
Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 5 mg + Metformin
n=41 Participants
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
n=44 Participants
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
Baseline Mean
|
237.6 mg/dL
Standard Error 8.87
|
233.1 mg/dL
Standard Error 7.74
|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
Week 4 Mean
|
198.5 mg/dL
Standard Error 8.82
|
231.1 mg/dL
Standard Error 9.22
|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
Adjusted Change from Baseline
|
-38.2 mg/dL
Standard Error 7.49
|
-2.8 mg/dL
Standard Error 7.23
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.
Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 5 mg + Metformin
n=38 Participants
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
n=44 Participants
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Change From Baseline in Mean Daily Glucose at Week 4
Baseline Mean
|
179.0 mg/dL
Standard Error 5.76
|
184.9 mg/dL
Standard Error 7.14
|
|
Change From Baseline in Mean Daily Glucose at Week 4
Week 4 Mean
|
167.5 mg/dL
Standard Error 4.87
|
191.8 mg/dL
Standard Error 8.41
|
|
Change From Baseline in Mean Daily Glucose at Week 4
Adjusted Change from Baseline
|
-11.7 mg/dL
Standard Error 3.02
|
7.0 mg/dL
Standard Error 2.94
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.
Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.
Outcome measures
| Measure |
Saxagliptin 5 mg + Metformin
n=46 Participants
Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
|
Placebo + Metformin
n=47 Participants
Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
|
|---|---|---|
|
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
Baseline Mean
|
152.2 mg/dL
Standard Error 4.14
|
158.9 mg/dL
Standard Error 5.80
|
|
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
Week 4 Last Observation Carried Forward Mean
|
141.9 mg/dL
Standard Error 3.99
|
162.9 mg/dL
Standard Error 6.00
|
|
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
Adjusted Mean Change from Baseline
|
-10.8 mg/dL
Standard Error 2.84
|
4.5 mg/dL
Standard Error 2.81
|
Adverse Events
PLACEBO + MET
SAXA 5MG + MET
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PLACEBO + MET
n=47 participants at risk
|
SAXA 5MG + MET
n=46 participants at risk
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
6.4%
3/47
|
2.2%
1/46
|
|
Gastrointestinal disorders
NAUSEA
|
6.4%
3/47
|
0.00%
0/46
|
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