Trial Outcomes & Findings for Study of Multiple Doses of Saxagliptin (BMS-477118) (NCT NCT00950599)
NCT ID: NCT00950599
Last Updated: 2015-04-03
Results Overview
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
COMPLETED
PHASE2
423 participants
Baseline, Week 12
2015-04-03
Participant Flow
Participant milestones
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
|
Saxagliptin 5 mg (0-40 mg Cohort)
The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
|
Saxagliptin 10 mg (0-40 mg Cohort)
The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
|
Saxagliptin 20 mg (0-40 mg Cohort)
The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
|
Saxagliptin 40 mg (0-40 mg Cohort)
The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
|
Placebo (0-40 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
|
Placebo (0 & 100 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
|
Saxa 0-40 mg Cohort (Follow-up Period)
The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
|
Saxa 0 & 100 mg Cohort (Follow-up Period)
The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
55
|
47
|
63
|
54
|
52
|
67
|
44
|
41
|
0
|
0
|
|
Double-Blind Treatment Period
COMPLETED
|
48
|
37
|
54
|
43
|
45
|
55
|
44
|
35
|
0
|
0
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
7
|
10
|
9
|
11
|
7
|
12
|
0
|
6
|
0
|
0
|
|
Follow-Up Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
309
|
80
|
|
Follow-Up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
296
|
78
|
|
Follow-Up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
2
|
Reasons for withdrawal
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
|
Saxagliptin 5 mg (0-40 mg Cohort)
The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
|
Saxagliptin 10 mg (0-40 mg Cohort)
The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
|
Saxagliptin 20 mg (0-40 mg Cohort)
The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
|
Saxagliptin 40 mg (0-40 mg Cohort)
The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
|
Placebo (0-40 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
|
Placebo (0 & 100 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
|
Saxa 0-40 mg Cohort (Follow-up Period)
The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
|
Saxa 0 & 100 mg Cohort (Follow-up Period)
The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period
Administrative reason by sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Adverse Event
|
0
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Lack of Efficacy
|
2
|
5
|
5
|
7
|
3
|
6
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Period
Poor/Noncompliance
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Period
Subject no longer meets study criteria
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Subject Withdrew consent
|
4
|
3
|
3
|
1
|
1
|
2
|
0
|
3
|
0
|
0
|
|
Follow-Up Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Follow-Up Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Follow-Up Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
|
Follow-Up Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Follow-Up Period
Poor/Noncompliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Follow-Up Period
Subject withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Study of Multiple Doses of Saxagliptin (BMS-477118)
Baseline characteristics by cohort
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=63 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=52 Participants
|
Placebo (0-40 mg Cohort)
n=67 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=44 Participants
|
Placebo (0 & 100 mg Cohort)
n=41 Participants
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
50 participants
n=5 Participants
|
39 participants
n=7 Participants
|
54 participants
n=5 Participants
|
50 participants
n=4 Participants
|
41 participants
n=21 Participants
|
55 participants
n=10 Participants
|
38 participants
n=115 Participants
|
35 participants
n=6 Participants
|
362 participants
n=6 Participants
|
|
Age, Customized
>= 65 years
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
4 participants
n=4 Participants
|
11 participants
n=21 Participants
|
12 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
61 participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
176 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
247 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=60 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=50 Participants
|
Placebo (0-40 mg Cohort)
n=62 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
|
-0.67 percentage of glycosylated hemoglobins
Standard Deviation 0.80
|
-0.95 percentage of glycosylated hemoglobins
Standard Deviation 0.97
|
-0.81 percentage of glycosylated hemoglobins
Standard Deviation 0.91
|
-0.74 percentage of glycosylated hemoglobins
Standard Deviation 0.93
|
-0.78 percentage of glycosylated hemoglobins
Standard Deviation 1.04
|
-0.29 percentage of glycosylated hemoglobins
Standard Deviation 0.82
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=60 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=50 Participants
|
Placebo (0-40 mg Cohort)
n=62 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
|
-0.72 percentage of glycosylated hemoglobins
Standard Error 0.12
|
-0.90 percentage of glycosylated hemoglobins
Standard Error 0.14
|
-0.81 percentage of glycosylated hemoglobins
Standard Error 0.11
|
-0.74 percentage of glycosylated hemoglobins
Standard Error 0.12
|
-0.80 percentage of glycosylated hemoglobins
Standard Error 0.12
|
-0.27 percentage of glycosylated hemoglobins
Standard Error 0.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=46 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=43 Participants
|
Placebo (0 & 100 mg Cohort)
n=35 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-0.71 percentage of glycosylated hemoglobins
Standard Error 0.09
|
-0.72 percentage of glycosylated hemoglobins
Standard Error 0.10
|
-0.67 percentage of glycosylated hemoglobins
Standard Error 0.09
|
-0.68 percentage of glycosylated hemoglobins
Standard Error 0.09
|
-0.82 percentage of glycosylated hemoglobins
Standard Error 0.09
|
-0.33 percentage of glycosylated hemoglobins
Standard Error 0.08
|
-1.09 percentage of glycosylated hemoglobins
Standard Error 0.09
|
-0.36 percentage of glycosylated hemoglobins
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=50 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=61 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=50 Participants
|
Placebo (0-40 mg Cohort)
n=63 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=43 Participants
|
Placebo (0 & 100 mg Cohort)
n=37 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-10.71 mg/dL
Standard Error 3.68
|
-18.63 mg/dL
Standard Error 3.82
|
-16.10 mg/dL
Standard Error 3.32
|
-14.66 mg/dL
Standard Error 3.57
|
-18.34 mg/dL
Standard Error 3.67
|
-6.20 mg/dL
Standard Error 3.26
|
-26.33 mg/dL
Standard Error 3.53
|
-3.29 mg/dL
Standard Error 3.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=50 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=61 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=50 Participants
|
Placebo (0-40 mg Cohort)
n=63 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
|
-10.85 mg/dL
Standard Error 4.61
|
-21.68 mg/dL
Standard Error 4.80
|
-15.91 mg/dL
Standard Error 4.16
|
-13.61 mg/dL
Standard Error 4.48
|
-16.36 mg/dL
Standard Error 4.60
|
2.81 mg/dL
Standard Error 4.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=61 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=49 Participants
|
Placebo (0-40 mg Cohort)
n=62 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=44 Participants
|
Placebo (0 & 100 mg Cohort)
n=36 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-21.02 umol/L
Standard Error 3.91
|
-21.87 umol/L
Standard Error 4.29
|
-24.72 umol/L
Standard Error 3.65
|
-23.96 umol/L
Standard Error 3.88
|
-26.03 umol/L
Standard Error 4.07
|
-9.26 umol/L
Standard Error 3.62
|
-28.03 umol/L
Standard Error 3.74
|
-0.16 umol/L
Standard Error 4.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=61 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=50 Participants
|
Placebo (0-40 mg Cohort)
n=62 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
|
-20.89 umol/L
Standard Error 4.64
|
-25.23 umol/L
Standard Error 5.14
|
-21.31 umol/L
Standard Error 4.36
|
-22.30 umol/L
Standard Error 4.64
|
-26.30 umol/L
Standard Error 4.82
|
-8.57 umol/L
Standard Error 4.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=36 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
1.88 uU/mL
Standard Error 1.22
|
1.05 uU/mL
Standard Error 1.26
|
-0.99 uU/mL
Standard Error 1.11
|
-0.17 uU/mL
Standard Error 1.18
|
0.38 uU/mL
Standard Error 1.23
|
0.08 uU/mL
Standard Error 1.11
|
-2.03 uU/mL
Standard Error 1.09
|
-0.61 uU/mL
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=49 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
|
2.38 uU/mL
Standard Error 1.63
|
1.02 uU/mL
Standard Error 1.93
|
1.41 uU/mL
Standard Error 1.54
|
0.76 uU/mL
Standard Error 1.74
|
2.29 uU/mL
Standard Error 1.65
|
1.29 uU/mL
Standard Error 1.51
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=36 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-0.15 ng/mL
Standard Error 0.12
|
-0.19 ng/mL
Standard Error 0.13
|
-0.06 ng/mL
Standard Error 0.11
|
-0.02 ng/mL
Standard Error 0.12
|
-0.03 ng/mL
Standard Error 0.13
|
-0.08 ng/mL
Standard Error 0.11
|
-0.52 ng/mL
Standard Error 0.12
|
-0.13 ng/mL
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=49 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
|
-0.04 ng/mL
Standard Error 0.14
|
-0.13 ng/mL
Standard Error 0.16
|
-0.09 ng/mL
Standard Error 0.13
|
0.01 ng/mL
Standard Error 0.14
|
-0.02 ng/mL
Standard Error 0.14
|
0.02 ng/mL
Standard Error 0.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=59 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-1226 mg*min/dL
Standard Error 318
|
-1503 mg*min/dL
Standard Error 353
|
-1312 mg*min/dL
Standard Error 290
|
-1246 mg*min/dL
Standard Error 320
|
-1626 mg*min/dL
Standard Error 324
|
-461 mg*min/dL
Standard Error 280
|
-2035 mg*min/dL
Standard Error 263
|
-664 mg*min/dL
Standard Error 283
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=29 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=40 Participants
|
Placebo (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
|
-1121 mg*min/dL
Standard Error 320
|
-1505 mg*min/dL
Standard Error 369
|
-1730 mg*min/dL
Standard Error 289
|
-1377 mg*min/dL
Standard Error 322
|
-1520 mg*min/dL
Standard Error 314
|
174 mg*min/dL
Standard Error 275
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=35 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
234.2 uU*min/mL
Standard Error 149.5
|
293.2 uU*min/mL
Standard Error 162.3
|
120.0 uU*min/mL
Standard Error 136.6
|
165.4 uU*min/mL
Standard Error 145.3
|
28.8 uU*min/mL
Standard Error 152.4
|
164.6 uU*min/mL
Standard Error 130.5
|
-296.0 uU*min/mL
Standard Error 160.4
|
261.9 uU*min/mL
Standard Error 167.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=26 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=38 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
|
61.2 uU*min/mL
Standard Error 179.9
|
283.4 uU*min/mL
Standard Error 218.0
|
114.2 uU*min/mL
Standard Error 163.6
|
336.8 uU*min/mL
Standard Error 177.7
|
195.6 uU*min/mL
Standard Error 180.7
|
30.3 uU*min/mL
Standard Error 155.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=43 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=34 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.2 ng*min/mL
Standard Error 9.4
|
7.6 ng*min/mL
Standard Error 10.3
|
-5.5 ng*min/mL
Standard Error 8.7
|
5.4 ng*min/mL
Standard Error 9.2
|
0.2 ng*min/mL
Standard Error 9.5
|
-0.8 ng*min/mL
Standard Error 8.3
|
-19.7 ng*min/mL
Standard Error 9.8
|
0.8 ng*min/mL
Standard Error 10.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=26 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=38 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
|
-8.1 ng*min/mL
Standard Error 11.5
|
4.8 ng*min/mL
Standard Error 14.0
|
-1.6 ng*min/mL
Standard Error 10.5
|
7.1 ng*min/mL
Standard Error 11.4
|
-3.4 ng*min/mL
Standard Error 11.6
|
-4.0 ng*min/mL
Standard Error 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=40 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=34 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-15.24 mg/dL
Standard Error 5.22
|
-16.53 mg/dL
Standard Error 5.75
|
-16.78 mg/dL
Standard Error 4.72
|
-14.35 mg/dL
Standard Error 4.92
|
-26.03 mg/dL
Standard Error 5.38
|
-9.30 mg/dL
Standard Error 4.76
|
-25.99 mg/dL
Standard Error 4.30
|
-6.80 mg/dL
Standard Error 4.61
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=34 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-23.45 mg/dL
Standard Error 6.09
|
-29.31 mg/dL
Standard Error 6.80
|
-25.32 mg/dL
Standard Error 5.52
|
-23.93 mg/dL
Standard Error 5.74
|
-30.60 mg/dL
Standard Error 6.12
|
-7.81 mg/dL
Standard Error 5.57
|
-36.33 mg/dL
Standard Error 4.99
|
-10.94 mg/dL
Standard Error 5.42
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=33 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=38 Participants
|
Placebo (0 & 100 mg Cohort)
n=35 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-28.45 mg/dL
Standard Error 6.85
|
-39.99 mg/dL
Standard Error 7.80
|
-27.51 mg/dL
Standard Error 6.21
|
-24.32 mg/dL
Standard Error 6.48
|
-34.44 mg/dL
Standard Error 6.90
|
-4.96 mg/dL
Standard Error 6.29
|
-44.58 mg/dL
Standard Error 5.65
|
-17.22 mg/dL
Standard Error 5.88
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=49 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
|
-14.89 mg/dL
Standard Error 4.78
|
-16.45 mg/dL
Standard Error 5.58
|
-19.57 mg/dL
Standard Error 4.35
|
-18.70 mg/dL
Standard Error 4.94
|
-20.75 mg/dL
Standard Error 4.77
|
0.77 mg/dL
Standard Error 4.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
|
-19.79 mg/dL
Standard Error 5.35
|
-24.04 mg/dL
Standard Error 6.21
|
-28.59 mg/dL
Standard Error 4.92
|
-23.56 mg/dL
Standard Error 5.52
|
-20.42 mg/dL
Standard Error 5.25
|
-2.08 mg/dL
Standard Error 4.76
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=49 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=50 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
|
-24.42 mg/dL
Standard Error 6.73
|
-35.30 mg/dL
Standard Error 7.84
|
-41.04 mg/dL
Standard Error 6.14
|
-27.54 mg/dL
Standard Error 6.97
|
-33.98 mg/dL
Standard Error 6.71
|
-1.41 mg/dL
Standard Error 6.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=49 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
5.36 uU/mL
Standard Error 2.74
|
2.22 uU/mL
Standard Error 3.02
|
2.47 uU/mL
Standard Error 2.53
|
3.11 uU/mL
Standard Error 2.66
|
-0.60 uU/mL
Standard Error 2.77
|
0.60 uU/mL
Standard Error 2.44
|
-1.72 uU/mL
Standard Error 3.07
|
1.63 uU/mL
Standard Error 3.25
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=38 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
5.20 uU/mL
Standard Error 3.39
|
8.51 uU/mL
Standard Error 3.81
|
2.04 uU/mL
Standard Error 3.18
|
1.10 uU/mL
Standard Error 3.35
|
-0.33 uU/mL
Standard Error 3.40
|
4.82 uU/mL
Standard Error 3.04
|
-4.44 uU/mL
Standard Error 3.30
|
7.69 uU/mL
Standard Error 3.54
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=34 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
2.35 uU/mL
Standard Error 4.06
|
4.45 uU/mL
Standard Error 4.49
|
0.25 uU/mL
Standard Error 3.73
|
4.75 uU/mL
Standard Error 3.93
|
-0.13 uU/mL
Standard Error 4.11
|
3.33 uU/mL
Standard Error 3.59
|
-8.17 uU/mL
Standard Error 4.37
|
1.83 uU/mL
Standard Error 4.56
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
|
2.93 uU/mL
Standard Error 3.67
|
5.79 uU/mL
Standard Error 4.49
|
2.87 uU/mL
Standard Error 3.37
|
6.81 uU/mL
Standard Error 3.74
|
-1.48 uU/mL
Standard Error 3.65
|
4.70 uU/mL
Standard Error 3.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
|
0.98 uU/mL
Standard Error 4.09
|
10.71 uU/mL
Standard Error 5.01
|
2.48 uU/mL
Standard Error 3.79
|
5.90 uU/mL
Standard Error 4.16
|
6.14 uU/mL
Standard Error 4.04
|
1.19 uU/mL
Standard Error 3.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=39 Participants
|
Placebo (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
|
2.62 uU/mL
Standard Error 4.36
|
4.61 uU/mL
Standard Error 5.31
|
0.38 uU/mL
Standard Error 3.95
|
4.99 uU/mL
Standard Error 4.39
|
2.42 uU/mL
Standard Error 4.40
|
-2.22 uU/mL
Standard Error 3.80
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=49 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.03 ng/mL
Standard Error 0.17
|
-0.09 ng/mL
Standard Error 0.19
|
-0.12 ng/mL
Standard Error 0.16
|
0.17 ng/mL
Standard Error 0.17
|
-0.14 ng/mL
Standard Error 0.17
|
-0.13 ng/mL
Standard Error 0.15
|
-0.27 ng/mL
Standard Error 0.17
|
0.01 ng/mL
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.13 ng/mL
Standard Error 0.20
|
0.16 ng/mL
Standard Error 0.23
|
-0.01 ng/mL
Standard Error 0.19
|
-0.06 ng/mL
Standard Error 0.20
|
-0.02 ng/mL
Standard Error 0.21
|
0.03 ng/mL
Standard Error 0.18
|
-0.35 ng/mL
Standard Error 0.21
|
0.05 ng/mL
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=34 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-0.06 ng/mL
Standard Error 0.22
|
0.36 ng/mL
Standard Error 0.25
|
-0.16 ng/mL
Standard Error 0.21
|
0.20 ng/mL
Standard Error 0.22
|
0.19 ng/mL
Standard Error 0.22
|
0.24 ng/mL
Standard Error 0.20
|
-0.33 ng/mL
Standard Error 0.25
|
-0.10 ng/mL
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
|
-0.02 ng/mL
Standard Error 0.23
|
0.11 ng/mL
Standard Error 0.28
|
-0.12 ng/mL
Standard Error 0.21
|
-0.02 ng/mL
Standard Error 0.23
|
-0.27 ng/mL
Standard Error 0.23
|
0.07 ng/mL
Standard Error 0.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
|
-0.17 ng/mL
Standard Error 0.23
|
0.27 ng/mL
Standard Error 0.29
|
0.05 ng/mL
Standard Error 0.22
|
0.19 ng/mL
Standard Error 0.24
|
0.12 ng/mL
Standard Error 0.23
|
-0.14 ng/mL
Standard Error 0.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=39 Participants
|
Placebo (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
|
-0.08 ng/mL
Standard Error 0.26
|
0.18 ng/mL
Standard Error 0.31
|
-0.02 ng/mL
Standard Error 0.23
|
0.22 ng/mL
Standard Error 0.26
|
0.01 ng/mL
Standard Error 0.26
|
0.22 ng/mL
Standard Error 0.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=56 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=59 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=38 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
1.42 mg/dL
Standard Error 2.54
|
-5.23 mg/dL
Standard Error 2.82
|
-1.15 mg/dL
Standard Error 2.36
|
3.48 mg/dL
Standard Error 2.64
|
-0.95 mg/dL
Standard Error 2.65
|
-2.37 mg/dL
Standard Error 2.30
|
-1.12 mg/dL
Standard Error 2.35
|
1.02 mg/dL
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=46 Participants
|
Placebo (0-40 mg Cohort)
n=59 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=38 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-7.39 mg/dL
Standard Error 3.24
|
-15.91 mg/dL
Standard Error 3.64
|
-6.92 mg/dL
Standard Error 3.05
|
-5.68 mg/dL
Standard Error 3.34
|
-6.89 mg/dL
Standard Error 3.30
|
-2.40 mg/dL
Standard Error 2.92
|
-12.76 mg/dL
Standard Error 3.87
|
-0.79 mg/dL
Standard Error 4.22
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=46 Participants
|
Placebo (0-40 mg Cohort)
n=59 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=38 Participants
|
Placebo (0 & 100 mg Cohort)
n=34 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-10.08 mg/dL
Standard Error 4.01
|
-23.94 mg/dL
Standard Error 4.57
|
-12.94 mg/dL
Standard Error 3.75
|
-6.10 mg/dL
Standard Error 4.14
|
-11.88 mg/dL
Standard Error 4.09
|
-1.31 mg/dL
Standard Error 3.63
|
-20.69 mg/dL
Standard Error 4.09
|
-8.59 mg/dL
Standard Error 4.32
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
|
-1.20 mg/dL
Standard Error 2.68
|
0.02 mg/dL
Standard Error 3.13
|
1.63 mg/dL
Standard Error 2.47
|
3.14 mg/dL
Standard Error 2.82
|
-0.14 mg/dL
Standard Error 2.68
|
1.89 mg/dL
Standard Error 2.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
|
-5.99 mg/dL
Standard Error 3.26
|
-5.24 mg/dL
Standard Error 3.82
|
-5.69 mg/dL
Standard Error 3.06
|
-0.73 mg/dL
Standard Error 3.40
|
-0.12 mg/dL
Standard Error 3.22
|
0.79 mg/dL
Standard Error 2.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
|
-9.29 mg/dL
Standard Error 4.26
|
-16.51 mg/dL
Standard Error 5.01
|
-19.44 mg/dL
Standard Error 3.94
|
-3.95 mg/dL
Standard Error 4.43
|
-13.83 mg/dL
Standard Error 4.27
|
0.30 mg/dL
Standard Error 3.79
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
5.58 uU/mL
Standard Error 2.53
|
-1.04 uU/mL
Standard Error 2.75
|
2.85 uU/mL
Standard Error 2.32
|
1.18 uU/mL
Standard Error 2.47
|
0.11 uU/mL
Standard Error 2.52
|
-0.28 uU/mL
Standard Error 2.24
|
2.19 uU/mL
Standard Error 2.62
|
2.67 uU/mL
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=38 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
4.95 uU/mL
Standard Error 3.25
|
5.07 uU/mL
Standard Error 3.61
|
2.40 uU/mL
Standard Error 3.05
|
-0.89 uU/mL
Standard Error 3.24
|
0.13 uU/mL
Standard Error 3.23
|
3.23 uU/mL
Standard Error 2.91
|
0.22 uU/mL
Standard Error 3.05
|
9.87 uU/mL
Standard Error 3.27
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=34 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
4.03 uU/mL
Standard Error 3.93
|
1.84 uU/mL
Standard Error 4.29
|
0.75 uU/mL
Standard Error 3.60
|
2.28 uU/mL
Standard Error 3.83
|
-0.16 uU/mL
Standard Error 3.93
|
1.82 uU/mL
Standard Error 3.47
|
-3.61 uU/mL
Standard Error 3.78
|
4.19 uU/mL
Standard Error 3.95
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
|
2.33 uU/mL
Standard Error 3.08
|
5.26 uU/mL
Standard Error 3.76
|
1.98 uU/mL
Standard Error 2.85
|
3.56 uU/mL
Standard Error 3.14
|
-1.49 uU/mL
Standard Error 3.05
|
4.42 uU/mL
Standard Error 2.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
|
-0.23 uU/mL
Standard Error 3.47
|
10.17 uU/mL
Standard Error 4.25
|
1.43 uU/mL
Standard Error 3.25
|
3.35 uU/mL
Standard Error 3.53
|
5.36 uU/mL
Standard Error 3.44
|
-0.70 uU/mL
Standard Error 3.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=39 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
|
2.71 uU/mL
Standard Error 3.97
|
4.85 uU/mL
Standard Error 4.82
|
-0.83 uU/mL
Standard Error 3.63
|
2.02 uU/mL
Standard Error 3.99
|
1.44 uU/mL
Standard Error 4.01
|
-3.52 uU/mL
Standard Error 3.51
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=53 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.29 ng/mL
Standard Error 0.14
|
-0.08 ng/mL
Standard Error 0.16
|
0.10 ng/mL
Standard Error 0.13
|
0.08 ng/mL
Standard Error 0.14
|
0.01 ng/mL
Standard Error 0.14
|
0.01 ng/mL
Standard Error 0.13
|
0.01 ng/mL
Standard Error 0.15
|
0.17 ng/mL
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.35 ng/mL
Standard Error 0.18
|
0.11 ng/mL
Standard Error 0.20
|
0.23 ng/mL
Standard Error 0.17
|
-0.07 ng/mL
Standard Error 0.18
|
0.12 ng/mL
Standard Error 0.18
|
0.09 ng/mL
Standard Error 0.16
|
-0.00 ng/mL
Standard Error 0.20
|
0.31 ng/mL
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=37 Participants
|
Placebo (0 & 100 mg Cohort)
n=34 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.27 ng/mL
Standard Error 0.20
|
0.35 ng/mL
Standard Error 0.22
|
0.17 ng/mL
Standard Error 0.19
|
0.12 ng/mL
Standard Error 0.20
|
0.36 ng/mL
Standard Error 0.20
|
0.17 ng/mL
Standard Error 0.18
|
0.04 ng/mL
Standard Error 0.21
|
0.20 ng/mL
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
|
0.23 ng/mL
Standard Error 0.16
|
0.42 ng/mL
Standard Error 0.20
|
0.02 ng/mL
Standard Error 0.15
|
0.02 ng/mL
Standard Error 0.17
|
-0.04 ng/mL
Standard Error 0.16
|
0.21 ng/mL
Standard Error 0.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
|
0.05 ng/mL
Standard Error 0.20
|
0.58 ng/mL
Standard Error 0.24
|
0.16 ng/mL
Standard Error 0.18
|
0.28 ng/mL
Standard Error 0.20
|
0.32 ng/mL
Standard Error 0.19
|
-0.08 ng/mL
Standard Error 0.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=39 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
|
0.29 ng/mL
Standard Error 0.22
|
0.59 ng/mL
Standard Error 0.27
|
0.16 ng/mL
Standard Error 0.20
|
0.27 ng/mL
Standard Error 0.22
|
0.20 ng/mL
Standard Error 0.22
|
0.13 ng/mL
Standard Error 0.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=41 Participants
|
Placebo (0-40 mg Cohort)
n=50 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=31 Participants
|
Placebo (0 & 100 mg Cohort)
n=30 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-11.84 pg/mL
Standard Error 4.11
|
-10.92 pg/mL
Standard Error 4.93
|
-11.26 pg/mL
Standard Error 3.99
|
-5.81 pg/mL
Standard Error 4.56
|
-9.04 pg/mL
Standard Error 4.21
|
-1.98 pg/mL
Standard Error 3.82
|
-14.97 pg/mL
Standard Error 3.69
|
1.17 pg/mL
Standard Error 3.75
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=22 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=35 Participants
|
Placebo (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
|
-8.39 pg/mL
Standard Error 4.12
|
-6.06 pg/mL
Standard Error 5.57
|
-12.64 pg/mL
Standard Error 4.30
|
-17.21 pg/mL
Standard Error 4.76
|
-11.90 pg/mL
Standard Error 4.41
|
-3.64 pg/mL
Standard Error 3.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=39 Participants
|
Placebo (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.01 mEg/L
Standard Error 0.03
|
-0.03 mEg/L
Standard Error 0.03
|
-0.07 mEg/L
Standard Error 0.02
|
-0.08 mEg/L
Standard Error 0.03
|
-0.05 mEg/L
Standard Error 0.03
|
-0.02 mEg/L
Standard Error 0.02
|
-0.17 mEg/L
Standard Error 0.02
|
-0.16 mEg/L
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=32 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=26 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=32 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=37 Participants
|
Placebo (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
|
0.01 mEg/L
Standard Error 0.03
|
-0.00 mEg/L
Standard Error 0.03
|
-0.06 mEg/L
Standard Error 0.03
|
-0.05 mEg/L
Standard Error 0.03
|
-0.04 mEg/L
Standard Error 0.03
|
-0.00 mEg/L
Standard Error 0.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=29 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=40 Participants
|
Placebo (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=31 Participants
|
Placebo (0 & 100 mg Cohort)
n=28 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-5.94 pg/mL
Standard Error 3.64
|
-5.75 pg/mL
Standard Error 4.42
|
-10.39 pg/mL
Standard Error 3.60
|
-3.94 pg/mL
Standard Error 4.02
|
-6.99 pg/mL
Standard Error 3.76
|
3.58 pg/mL
Standard Error 3.45
|
-8.54 pg/mL
Standard Error 3.87
|
0.52 pg/mL
Standard Error 4.07
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=21 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=36 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=35 Participants
|
Placebo (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
|
-5.96 pg/mL
Standard Error 3.29
|
-4.46 pg/mL
Standard Error 4.47
|
-6.80 pg/mL
Standard Error 3.42
|
-10.36 pg/mL
Standard Error 3.74
|
-8.56 pg/mL
Standard Error 3.47
|
4.53 pg/mL
Standard Error 3.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=34 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=30 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=34 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=36 Participants
|
Placebo (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=31 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-0.02 mEq/mL
Standard Error 0.02
|
0.01 mEq/mL
Standard Error 0.02
|
-0.02 mEq/mL
Standard Error 0.02
|
0.00 mEq/mL
Standard Error 0.02
|
0.02 mEq/mL
Standard Error 0.02
|
-0.01 mEq/mL
Standard Error 0.02
|
-0.07 mEq/mL
Standard Error 0.02
|
-0.12 mEq/mL
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=32 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=21 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=28 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=32 Participants
|
Placebo (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
|
-0.01 mEq/mL
Standard Error 0.02
|
-0.04 mEq/mL
Standard Error 0.03
|
0.02 mEq/mL
Standard Error 0.02
|
-0.01 mEq/mL
Standard Error 0.02
|
0.03 mEq/mL
Standard Error 0.02
|
-0.04 mEq/mL
Standard Error 0.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=34 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=20 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=31 Participants
|
Placebo (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=31 Participants
|
Placebo (0 & 100 mg Cohort)
n=23 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
0.38 units on a scale
Standard Deviation 2.04
|
-0.31 units on a scale
Standard Deviation 2.41
|
0.45 units on a scale
Standard Deviation 1.88
|
-0.22 units on a scale
Standard Deviation 1.22
|
0.04 units on a scale
Standard Deviation 2.00
|
0.22 units on a scale
Standard Deviation 1.80
|
-0.25 units on a scale
Standard Deviation 4.52
|
-0.63 units on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=28 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=16 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=26 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=26 Participants
|
Placebo (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
|
0.50 units on a scale
Standard Deviation 2.03
|
-0.19 units on a scale
Standard Deviation 1.77
|
-0.13 units on a scale
Standard Deviation 1.91
|
-0.34 units on a scale
Standard Deviation 1.21
|
0.22 units on a scale
Standard Deviation 1.54
|
-0.05 units on a scale
Standard Deviation 1.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=34 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=20 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=27 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=31 Participants
|
Placebo (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=31 Participants
|
Placebo (0 & 100 mg Cohort)
n=23 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
|
0.44 units on a scale
Standard Deviation 1.06
|
0.37 units on a scale
Standard Deviation 0.76
|
0.31 units on a scale
Standard Deviation 0.77
|
0.18 units on a scale
Standard Deviation 0.81
|
0.71 units on a scale
Standard Deviation 3.71
|
0.04 units on a scale
Standard Deviation 0.72
|
0.46 units on a scale
Standard Deviation 1.17
|
-0.05 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=28 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=16 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=26 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=26 Participants
|
Placebo (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
|
0.15 units on a scale
Standard Deviation 0.99
|
0.84 units on a scale
Standard Deviation 2.31
|
0.35 units on a scale
Standard Deviation 0.97
|
-0.05 units on a scale
Standard Deviation 0.50
|
0.25 units on a scale
Standard Deviation 0.58
|
0.11 units on a scale
Standard Deviation 0.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=36 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=52 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=42 Participants
|
Placebo (0-40 mg Cohort)
n=57 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=35 Participants
|
Placebo (0 & 100 mg Cohort)
n=31 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
|
-0.36 units on a scale
Standard Deviation 1.36
|
0.31 units on a scale
Standard Deviation 1.27
|
-0.04 units on a scale
Standard Deviation 2.84
|
0.31 units on a scale
Standard Deviation 1.76
|
-0.06 units on a scale
Standard Deviation 2.49
|
-0.25 units on a scale
Standard Deviation 1.91
|
0.86 units on a scale
Standard Deviation 2.86
|
0.35 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=26 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=39 Participants
|
Placebo (0-40 mg Cohort)
n=51 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
|
-0.48 units on a scale
Standard Deviation 2.81
|
0.34 units on a scale
Standard Deviation 1.21
|
0.27 units on a scale
Standard Deviation 3.90
|
0.78 units on a scale
Standard Deviation 3.24
|
0.17 units on a scale
Standard Deviation 3.68
|
-0.15 units on a scale
Standard Deviation 1.66
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=46 Participants
|
Placebo (0-40 mg Cohort)
n=59 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=41 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
|
-0.55 percentage of glycated hemoglobins
Standard Deviation 0.93
|
-0.84 percentage of glycated hemoglobins
Standard Deviation 1.04
|
-0.78 percentage of glycated hemoglobins
Standard Deviation 0.98
|
-0.66 percentage of glycated hemoglobins
Standard Deviation 1.03
|
-0.69 percentage of glycated hemoglobins
Standard Deviation 1.04
|
-0.25 percentage of glycated hemoglobins
Standard Deviation 0.83
|
-1.15 percentage of glycated hemoglobins
Standard Deviation 0.76
|
-0.45 percentage of glycated hemoglobins
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline, Week 10, Week 16Population: Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=56 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=45 Participants
|
Placebo (0-40 mg Cohort)
n=56 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=41 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
|
-0.34 percentage of glycated hemoglobins
Standard Deviation 0.98
|
-0.72 percentage of glycated hemoglobins
Standard Deviation 0.96
|
-0.64 percentage of glycated hemoglobins
Standard Deviation 0.99
|
-0.57 percentage of glycated hemoglobins
Standard Deviation 0.94
|
-0.53 percentage of glycated hemoglobins
Standard Deviation 0.97
|
-0.24 percentage of glycated hemoglobins
Standard Deviation 0.87
|
-1.01 percentage of glycated hemoglobins
Standard Deviation 0.70
|
-0.43 percentage of glycated hemoglobins
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 14Population: Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=46 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=39 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=56 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=43 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
|
-1.93 mg/dL
Standard Deviation 36.86
|
-14.03 mg/dL
Standard Deviation 34.62
|
-7.58 mg/dL
Standard Deviation 29.35
|
-11.17 mg/dL
Standard Deviation 33.97
|
-6.02 mg/dL
Standard Deviation 38.40
|
-0.75 mg/dL
Standard Deviation 29.11
|
-14.14 mg/dL
Standard Deviation 26.14
|
-3.47 mg/dL
Standard Deviation 26.80
|
SECONDARY outcome
Timeframe: Baseline, Week 10, Week 16Population: Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=39 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
|
-5.82 mg/dL
Standard Deviation 31.60
|
-11.55 mg/dL
Standard Deviation 33.73
|
-6.65 mg/dL
Standard Deviation 46.36
|
-9.05 mg/dL
Standard Deviation 28.62
|
-0.91 mg/dL
Standard Deviation 33.94
|
-2.04 mg/dL
Standard Deviation 40.19
|
-7.82 mg/dL
Standard Deviation 23.88
|
-5.97 mg/dL
Standard Deviation 21.76
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 14Population: Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=40 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=56 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=44 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
|
-12.40 umol/L
Standard Deviation 35.18
|
-19.78 umol/L
Standard Deviation 33.80
|
-12.77 umol/L
Standard Deviation 37.92
|
-17.10 umol/L
Standard Deviation 39.36
|
-12.81 umol/L
Standard Deviation 32.41
|
-7.48 umol/L
Standard Deviation 34.15
|
-21.86 umol/L
Standard Deviation 31.39
|
-5.97 umol/L
Standard Deviation 23.67
|
SECONDARY outcome
Timeframe: Baseline, Week 10, Week 16Population: Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=45 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=44 Participants
|
Placebo (0-40 mg Cohort)
n=56 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=40 Participants
|
Placebo (0 & 100 mg Cohort)
n=32 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
|
-8.60 umol/L
Standard Deviation 39.61
|
-8.02 umol/L
Standard Deviation 37.54
|
-11.02 umol/L
Standard Deviation 40.73
|
-19.44 umol/L
Standard Deviation 37.39
|
-10.14 umol/L
Standard Deviation 31.45
|
-7.05 umol/L
Standard Deviation 35.13
|
-15.25 umol/L
Standard Deviation 30.78
|
-10.00 umol/L
Standard Deviation 24.26
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C \<7%, ≥7% to \<8%, ≥8% to \<9%, and ≥9% in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
|
Saxagliptin 20 mg (0-40 mg Cohort)
|
Saxagliptin 40 mg (0-40 mg Cohort)
|
Placebo (0-40 mg Cohort)
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
<7% (n=8; n=12)
|
-0.61 percent
Standard Deviation 0.26
|
-0.18 percent
Standard Deviation 0.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
≥7% to <8% (n=20; n=8)
|
-1.01 percent
Standard Deviation 0.41
|
-0.30 percent
Standard Deviation 0.15
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
≥8% to <9% (n=9; n=11)
|
-1.14 percent
Standard Deviation 0.53
|
-0.34 percent
Standard Deviation 0.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
≥9% (n=6; n=4)
|
-2.10 percent
Standard Deviation 0.88
|
-0.83 percent
Standard Deviation 0.31
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG \<140 mg/dL, ≥140 mg/dL to \<180 mg/dL, and ≥ 180 mg/dL in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=43 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=37 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
|
Saxagliptin 20 mg (0-40 mg Cohort)
|
Saxagliptin 40 mg (0-40 mg Cohort)
|
Placebo (0-40 mg Cohort)
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
< 140 mg/dL (n=17; n=17)
|
-11.12 mg/dL
Standard Deviation 12.51
|
1.29 mg/dL
Standard Deviation 12.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
140 - < 180 mg/dL (n=17; n=14)
|
-27.00 mg/dL
Standard Deviation 19.47
|
0.07 mg/dL
Standard Deviation 26.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
≥180 mg/dL (n=9; n=6)
|
-56.89 mg/dL
Standard Deviation 25.21
|
-19.50 mg/dL
Standard Deviation 48.14
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose \<140 mg/dL, ≥140 to \<200 mg/dL, and ≥200 mg/dL in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=38 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=35 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
|
Saxagliptin 20 mg (0-40 mg Cohort)
|
Saxagliptin 40 mg (0-40 mg Cohort)
|
Placebo (0-40 mg Cohort)
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
≥140 to <200 mg/dL (n=17; n=12)
|
-24.29 mg/dL
Standard Deviation 21.44
|
-19.25 mg/dL
Standard Deviation 25.30
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
<140 mg/dL (n=1; n=3)
|
-18.00 mg/dL
Standard Deviation 0.00
|
11.33 mg/dL
Standard Deviation 12.10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
≥200 mg/dL (n=20; n=20)
|
-62.10 mg/dL
Standard Deviation 34.83
|
-21.35 mg/dL
Standard Deviation 57.10
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.
Percentage of participants achieving A1C \< 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 \& 100 mg cohort.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
|
Saxagliptin 20 mg (0-40 mg Cohort)
|
Saxagliptin 40 mg (0-40 mg Cohort)
|
Placebo (0-40 mg Cohort)
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
|
72 Percentage of Participants
|
49 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 \& 100 mg cohort. (Note: this analysis was not performed.)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 \& 100 mg cohort. (Note: this analysis was not performed.)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, Week 6Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for DiscontinuationsPopulation: All participants randomized and treated during the double-blind period.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=55 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=47 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=63 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=54 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=52 Participants
|
Placebo (0-40 mg Cohort)
n=67 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
At least one related AE
|
14.5 Percentage of participants
|
23.4 Percentage of participants
|
22.2 Percentage of participants
|
25.9 Percentage of participants
|
23.1 Percentage of participants
|
23.9 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
At least one AE
|
80.0 Percentage of participants
|
76.6 Percentage of participants
|
77.8 Percentage of participants
|
87.0 Percentage of participants
|
75.0 Percentage of participants
|
79.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
At least one SAE
|
1.8 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
1.9 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
Deaths
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
Discontinuations due to AEs
|
0 Percentage of participants
|
2.1 Percentage of participants
|
1.6 Percentage of participants
|
1.9 Percentage of participants
|
3.8 Percentage of participants
|
1.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for DiscontinuationsPopulation: All participants randomized and treated during the double-blind period.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=41 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
|
Saxagliptin 20 mg (0-40 mg Cohort)
|
Saxagliptin 40 mg (0-40 mg Cohort)
|
Placebo (0-40 mg Cohort)
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
At least one AE
|
65.9 Percentage of participants
|
58.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
At least one SAE
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
At least one related AE
|
22.7 Percentage of participants
|
12.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
Deaths
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
Discontinuations due to AEs
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and DiscontinuationsPopulation: All participants treated during the follow-up period.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=50 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=42 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
n=58 Participants
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=48 Participants
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=47 Participants
|
Placebo (0-40 mg Cohort)
n=60 Participants
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
At least one AE
|
34.0 Percentage of participants
|
42.9 Percentage of participants
|
37.9 Percentage of participants
|
37.5 Percentage of participants
|
42.6 Percentage of participants
|
26.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
At least one SAE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.1 Percentage of participants
|
0 Percentage of participants
|
1.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
At least one related AE
|
4.0 Percentage of participants
|
7.1 Percentage of participants
|
3.4 Percentage of participants
|
12.5 Percentage of participants
|
4.3 Percentage of participants
|
6.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
Deaths
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
Discontinuations due to AEs
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and DiscontinuationsPopulation: All participants treated during the follow-up period.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=44 Participants
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=36 Participants
|
Saxagliptin 10 mg (0-40 mg Cohort)
|
Saxagliptin 20 mg (0-40 mg Cohort)
|
Saxagliptin 40 mg (0-40 mg Cohort)
|
Placebo (0-40 mg Cohort)
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
|
Placebo (0 & 100 mg Cohort)
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
At least one AE
|
31.8 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
At least one SAE
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
At least one related SAE
|
2.3 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
Deaths
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
Discontinuations due to AEs
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Saxagliptin 10 mg (0-40 mg Cohort)
Saxagliptin 100 mg (0 & 100 mg Cohort)
Saxagliptin 2.5 mg (0-40 mg Cohort)
Saxagliptin 20 mg (0-40 mg Cohort)
Saxagliptin 40 mg (0-40 mg Cohort)
Saxagliptin 5 mg (0-40 mg Cohort)
Placebo (0 & 100 mg Cohort)
Placebo (0-40 mg Cohort)
Serious adverse events
| Measure |
Saxagliptin 10 mg (0-40 mg Cohort)
n=63 participants at risk
The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=44 participants at risk
The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
|
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=55 participants at risk
The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=54 participants at risk
The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=52 participants at risk
The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=47 participants at risk
The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
|
Placebo (0 & 100 mg Cohort)
n=41 participants at risk
The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
|
Placebo (0-40 mg Cohort)
n=67 participants at risk
The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Rectocele
|
0.00%
0/63
|
0.00%
0/44
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
0.00%
0/67
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/63
|
0.00%
0/44
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
1.5%
1/67
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63
|
0.00%
0/44
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
0.00%
0/67
|
|
Infections and infestations
Appendicitis
|
1.6%
1/63
|
0.00%
0/44
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
0.00%
0/67
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/63
|
0.00%
0/44
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
0.00%
0/67
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/63
|
0.00%
0/44
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
1.5%
1/67
|
|
Renal and urinary disorders
Cystocele
|
0.00%
0/63
|
0.00%
0/44
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
0.00%
0/67
|
Other adverse events
| Measure |
Saxagliptin 10 mg (0-40 mg Cohort)
n=63 participants at risk
The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
|
Saxagliptin 100 mg (0 & 100 mg Cohort)
n=44 participants at risk
The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
|
Saxagliptin 2.5 mg (0-40 mg Cohort)
n=55 participants at risk
The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
|
Saxagliptin 20 mg (0-40 mg Cohort)
n=54 participants at risk
The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
|
Saxagliptin 40 mg (0-40 mg Cohort)
n=52 participants at risk
The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
|
Saxagliptin 5 mg (0-40 mg Cohort)
n=47 participants at risk
The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
|
Placebo (0 & 100 mg Cohort)
n=41 participants at risk
The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
|
Placebo (0-40 mg Cohort)
n=67 participants at risk
The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood Pressure Increased
|
0.00%
0/63
|
0.00%
0/44
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/52
|
0.00%
0/47
|
0.00%
0/41
|
6.0%
4/67
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/63
|
2.3%
1/44
|
1.8%
1/55
|
3.7%
2/54
|
3.8%
2/52
|
6.4%
3/47
|
0.00%
0/41
|
1.5%
1/67
|
|
Vascular disorders
Hot Flush
|
1.6%
1/63
|
0.00%
0/44
|
5.5%
3/55
|
0.00%
0/54
|
1.9%
1/52
|
0.00%
0/47
|
0.00%
0/41
|
1.5%
1/67
|
|
Nervous system disorders
Headache
|
15.9%
10/63
|
11.4%
5/44
|
14.5%
8/55
|
11.1%
6/54
|
9.6%
5/52
|
8.5%
4/47
|
4.9%
2/41
|
9.0%
6/67
|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/63
|
0.00%
0/44
|
1.8%
1/55
|
3.7%
2/54
|
9.6%
5/52
|
4.3%
2/47
|
4.9%
2/41
|
7.5%
5/67
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/63
|
4.5%
2/44
|
5.5%
3/55
|
0.00%
0/54
|
1.9%
1/52
|
6.4%
3/47
|
0.00%
0/41
|
6.0%
4/67
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/63
|
0.00%
0/44
|
0.00%
0/55
|
7.4%
4/54
|
1.9%
1/52
|
2.1%
1/47
|
0.00%
0/41
|
0.00%
0/67
|
|
Gastrointestinal disorders
Constipation
|
4.8%
3/63
|
6.8%
3/44
|
5.5%
3/55
|
5.6%
3/54
|
5.8%
3/52
|
0.00%
0/47
|
4.9%
2/41
|
3.0%
2/67
|
|
Infections and infestations
Influenza
|
3.2%
2/63
|
0.00%
0/44
|
5.5%
3/55
|
1.9%
1/54
|
3.8%
2/52
|
0.00%
0/47
|
2.4%
1/41
|
4.5%
3/67
|
|
Infections and infestations
Sinusitis
|
6.3%
4/63
|
4.5%
2/44
|
3.6%
2/55
|
1.9%
1/54
|
1.9%
1/52
|
4.3%
2/47
|
4.9%
2/41
|
6.0%
4/67
|
|
Infections and infestations
Bronchitis
|
3.2%
2/63
|
0.00%
0/44
|
1.8%
1/55
|
1.9%
1/54
|
1.9%
1/52
|
2.1%
1/47
|
0.00%
0/41
|
6.0%
4/67
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
5/63
|
2.3%
1/44
|
0.00%
0/55
|
5.6%
3/54
|
11.5%
6/52
|
4.3%
2/47
|
2.4%
1/41
|
7.5%
5/67
|
|
Infections and infestations
Urinary Tract Infection
|
6.3%
4/63
|
9.1%
4/44
|
10.9%
6/55
|
9.3%
5/54
|
3.8%
2/52
|
4.3%
2/47
|
4.9%
2/41
|
7.5%
5/67
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.5%
6/63
|
0.00%
0/44
|
10.9%
6/55
|
11.1%
6/54
|
0.00%
0/52
|
6.4%
3/47
|
0.00%
0/41
|
6.0%
4/67
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/63
|
0.00%
0/44
|
5.5%
3/55
|
1.9%
1/54
|
3.8%
2/52
|
2.1%
1/47
|
0.00%
0/41
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.6%
1/63
|
0.00%
0/44
|
5.5%
3/55
|
7.4%
4/54
|
1.9%
1/52
|
4.3%
2/47
|
0.00%
0/41
|
4.5%
3/67
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/63
|
2.3%
1/44
|
10.9%
6/55
|
9.3%
5/54
|
3.8%
2/52
|
6.4%
3/47
|
2.4%
1/41
|
3.0%
2/67
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.2%
2/63
|
0.00%
0/44
|
5.5%
3/55
|
3.7%
2/54
|
5.8%
3/52
|
4.3%
2/47
|
2.4%
1/41
|
4.5%
3/67
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/63
|
4.5%
2/44
|
7.3%
4/55
|
5.6%
3/54
|
5.8%
3/52
|
6.4%
3/47
|
0.00%
0/41
|
4.5%
3/67
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.8%
3/63
|
4.5%
2/44
|
1.8%
1/55
|
0.00%
0/54
|
1.9%
1/52
|
6.4%
3/47
|
2.4%
1/41
|
3.0%
2/67
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/63
|
2.3%
1/44
|
3.6%
2/55
|
1.9%
1/54
|
3.8%
2/52
|
6.4%
3/47
|
0.00%
0/41
|
6.0%
4/67
|
|
General disorders
Fatigue
|
1.6%
1/63
|
6.8%
3/44
|
3.6%
2/55
|
3.7%
2/54
|
5.8%
3/52
|
0.00%
0/47
|
4.9%
2/41
|
0.00%
0/67
|
|
General disorders
Oedema Peripheral
|
6.3%
4/63
|
4.5%
2/44
|
0.00%
0/55
|
1.9%
1/54
|
3.8%
2/52
|
2.1%
1/47
|
2.4%
1/41
|
11.9%
8/67
|
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