Clinical Trials/NCT00950599

NCT00950599

Completed

Phase 2

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

AstraZeneca0 sites423 target enrollmentMay 2003

ConditionsType 2 Diabetes Mellitus

InterventionsSaxagliptin Placebo

DrugsSaxagliptin Placebo

Overview

Phase: Phase 2
Intervention: Saxagliptin
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 423
Primary Endpoint: Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

May 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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

Arms & Interventions

Saxagliptin (2.5 mg)

Intervention: Saxagliptin

Saxagliptin (5 mg)

Intervention: Saxagliptin

Saxagliptin (10 mg)

Intervention: Saxagliptin

Saxagliptin (20 mg)

Intervention: Saxagliptin

Saxagliptin (40 mg)

Intervention: Saxagliptin

Saxagliptin (100 mg)

Intervention: Saxagliptin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort

Time Frame: Baseline, Week 12

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.

Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort

Time Frame: Baseline, Week 12

Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

Secondary Outcomes

Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
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(Baseline, Week 6)
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort(Baseline, Week 6)
Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort(Baseline, Week 6)
Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control(Week 4, Week 6)
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(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 Discontinuations)
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.(Baseline, Week 6)
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 14)
Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 10, Week 16)
Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 8, Week 14)
Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 10, Week 16)
Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 8, Week 14)
Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 10, Week 16)
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort(Baseline, Week 6)
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.(Baseline, Week 6)
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort(Baseline, Week 6)
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort(Week 6)
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(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 Discontinuations)
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(From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations)
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(From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations)