Phase 2
Completed N=423
Study of Multiple Doses of Saxagliptin (BMS-477118)
Source: ClinicalTrials.gov NCT00950599 ↗Enrolled (actual)
423
Serious AEs
1.4%
Results posted
Feb 2010
Primary outcomePrimary: 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; -0.95; -0.81; -0.74 percentage of glycosylated hemoglobins — p=0.9888
Summary
To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -0.95; -0.81; -0.74; -0.78; -0.29 | 0.9888 |
| PRIMARY Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort |
-0.72; -0.90; -0.81; -0.74; -0.80; -0.27 | 0.9888 |
| SECONDARY Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-0.71; -0.72; -0.67; -0.68; -0.82; -0.33 | — |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-10.71; -18.63; -16.10; -14.66; -18.34; -6.20 | — |
| SECONDARY Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort |
-10.85; -21.68; -15.91; -13.61; -16.36; 2.81 | — |
| SECONDARY Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-21.02; -21.87; -24.72; -23.96; -26.03; -9.26 | — |
| SECONDARY Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort |
-20.89; -25.23; -21.31; -22.30; -26.30; -8.57 | — |
| SECONDARY Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
1.88; 1.05; -0.99; -0.17; 0.38; 0.08 | — |
| SECONDARY Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort |
2.38; 1.02; 1.41; 0.76; 2.29; 1.29 | — |
| SECONDARY Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-0.15; -0.19; -0.06; -0.02; -0.03; -0.08 | — |
| SECONDARY Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort |
-0.04; -0.13; -0.09; 0.01; -0.02; 0.02 | — |
| SECONDARY 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; -1503; -1312; -1246; -1626; -461 | — |
| SECONDARY Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort |
-1121; -1505; -1730; -1377; -1520; 174 | — |
| SECONDARY Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
234.2; 293.2; 120.0; 165.4; 28.8; 164.6 | — |
| SECONDARY Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort |
61.2; 283.4; 114.2; 336.8; 195.6; 30.3 | — |
| SECONDARY 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; 7.6; -5.5; 5.4; 0.2; -0.8 | — |
| SECONDARY Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort |
-8.1; 4.8; -1.6; 7.1; -3.4; -4.0 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-15.24; -16.53; -16.78; -14.35; -26.03; -9.30 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-23.45; -29.31; -25.32; -23.93; -30.60; -7.81 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-28.45; -39.99; -27.51; -24.32; -34.44; -4.96 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort |
-14.89; -16.45; -19.57; -18.70; -20.75; 0.77 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort |
-19.79; -24.04; -28.59; -23.56; -20.42; -2.08 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort |
-24.42; -35.30; -41.04; -27.54; -33.98; -1.41 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
5.36; 2.22; 2.47; 3.11; -0.60; 0.60 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
5.20; 8.51; 2.04; 1.10; -0.33; 4.82 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
2.35; 4.45; 0.25; 4.75; -0.13; 3.33 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort |
2.93; 5.79; 2.87; 6.81; -1.48; 4.70 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort |
0.98; 10.71; 2.48; 5.90; 6.14; 1.19 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort |
2.62; 4.61; 0.38; 4.99; 2.42; -2.22 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
0.03; -0.09; -0.12; 0.17; -0.14; -0.13 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
0.13; 0.16; -0.01; -0.06; -0.02; 0.03 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-0.06; 0.36; -0.16; 0.20; 0.19; 0.24 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort |
-0.02; 0.11; -0.12; -0.02; -0.27; 0.07 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort |
-0.17; 0.27; 0.05; 0.19; 0.12; -0.14 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort |
-0.08; 0.18; -0.02; 0.22; 0.01; 0.22 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
1.42; -5.23; -1.15; 3.48; -0.95; -2.37 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-7.39; -15.91; -6.92; -5.68; -6.89; -2.40 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-10.08; -23.94; -12.94; -6.10; -11.88; -1.31 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort |
-1.20; 0.02; 1.63; 3.14; -0.14; 1.89 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort |
-5.99; -5.24; -5.69; -0.73; -0.12; 0.79 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort |
-9.29; -16.51; -19.44; -3.95; -13.83; 0.30 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
5.58; -1.04; 2.85; 1.18; 0.11; -0.28 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
4.95; 5.07; 2.40; -0.89; 0.13; 3.23 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
4.03; 1.84; 0.75; 2.28; -0.16; 1.82 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort |
2.33; 5.26; 1.98; 3.56; -1.49; 4.42 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort |
-0.23; 10.17; 1.43; 3.35; 5.36; -0.70 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort |
2.71; 4.85; -0.83; 2.02; 1.44; -3.52 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
0.29; -0.08; 0.10; 0.08; 0.01; 0.01 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
0.35; 0.11; 0.23; -0.07; 0.12; 0.09 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
0.27; 0.35; 0.17; 0.12; 0.36; 0.17 | — |
| SECONDARY Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort |
0.23; 0.42; 0.02; 0.02; -0.04; 0.21 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort |
0.05; 0.58; 0.16; 0.28; 0.32; -0.08 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort |
0.29; 0.59; 0.16; 0.27; 0.20; 0.13 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-11.84; -10.92; -11.26; -5.81; -9.04; -1.98 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort |
-8.39; -6.06; -12.64; -17.21; -11.90; -3.64 | — |
| SECONDARY 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; -0.03; -0.07; -0.08; -0.05; -0.02 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort |
0.01; -0.00; -0.06; -0.05; -0.04; -0.00 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-5.94; -5.75; -10.39; -3.94; -6.99; 3.58 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort |
-5.96; -4.46; -6.80; -10.36; -8.56; 4.53 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-0.02; 0.01; -0.02; 0.00; 0.02; -0.01 | — |
| SECONDARY Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort |
-0.01; -0.04; 0.02; -0.01; 0.03; -0.04 | — |
| SECONDARY Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
0.38; -0.31; 0.45; -0.22; 0.04; 0.22 | — |
| SECONDARY Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort |
0.50; -0.19; -0.13; -0.34; 0.22; -0.05 | — |
| SECONDARY Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. |
0.44; 0.37; 0.31; 0.18; 0.71; 0.04 | — |
| SECONDARY Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort |
0.15; 0.84; 0.35; -0.05; 0.25; 0.11 | — |
| SECONDARY Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts |
-0.36; 0.31; -0.04; 0.31; -0.06; -0.25 | — |
| SECONDARY Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort |
-0.48; 0.34; 0.27; 0.78; 0.17; -0.15 | — |
| SECONDARY 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; -0.84; -0.78; -0.66; -0.69; -0.25 | — |
| SECONDARY 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; -0.72; -0.64; -0.57; -0.53; -0.24 | — |
| SECONDARY 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; -14.03; -7.58; -11.17; -6.02; -0.75 | — |
| SECONDARY 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; -11.55; -6.65; -9.05; -0.91; -2.04 | — |
| SECONDARY 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; -19.78; -12.77; -17.10; -12.81; -7.48 | — |
| SECONDARY 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; -8.02; -11.02; -19.44; -10.14; -7.05 | — |
| SECONDARY Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort |
-0.61; -0.18; -1.01; -0.30; -1.14; -0.34 | — |
| SECONDARY Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. |
-11.12; 1.29; -27.00; 0.07; -56.89; -19.50 | — |
| SECONDARY Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort |
-18.00; 11.33; -24.29; -19.25; -62.10; -21.35 | — |
| SECONDARY Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort |
72; 49 | — |
| SECONDARY Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort |
— | — |
| SECONDARY Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort |
— | — |
| SECONDARY Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control |
— | — |
| SECONDARY 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 |
80.0; 76.6; 77.8; 87.0; 75.0; 79.1 | — |
| SECONDARY 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 |
65.9; 58.5; 0; 0; 22.7; 12.2 | — |
| SECONDARY 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 |
34.0; 42.9; 37.9; 37.5; 42.6; 26.7 | — |
| SECONDARY 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 |
31.8; 33.3; 0; 0; 2.3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes who are drug-naive
- Screening HbA1c ≥ 6.8% and ≤ 9.7%
- Screening fasting or random C-peptide > 0.5 ng/mL
- < 35 years old must be negative for anti-GAD antibodies
- Body Mass Index < 35 kg/m2
Exclusion Criteria
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
- Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
- Significant cardiovascular history
Data sourced from ClinicalTrials.gov (NCT00950599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.