Study of Multiple Doses of Saxagliptin (BMS-477118)

March 16, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

423

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 6 and 12 weeks
Experimental: Saxagliptin (2.5 mg)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Other Names:
  • BMS-477118
Experimental: Saxagliptin (5 mg)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Other Names:
  • BMS-477118
Experimental: Saxagliptin (10 mg)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Other Names:
  • BMS-477118
Experimental: Saxagliptin (20 mg)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Other Names:
  • BMS-477118
Experimental: Saxagliptin (40 mg)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Other Names:
  • BMS-477118
Experimental: Saxagliptin (100 mg)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Other Names:
  • BMS-477118

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12
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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo 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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo 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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo 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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
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
Time Frame: Baseline, Week 6
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.
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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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
Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
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
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time Frame: Baseline, Week 6
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).
Baseline, Week 6
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
Time Frame: Baseline, Week 12
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).
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
Time Frame: Baseline, Week 14
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.
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
Time Frame: Baseline, Week 10, Week 16
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.
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
Time Frame: Baseline, Week 8, Week 14
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.
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
Time Frame: Baseline, Week 10, Week 16
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.
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
Time Frame: Baseline, Week 8, Week 14
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.
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
Time Frame: Baseline, Week 10, Week 16
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.
Baseline, Week 10, Week 16
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
Time Frame: Week 6
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.
Week 6
Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort
Time Frame: Baseline, Week 6
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.)
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort
Time Frame: Baseline, Week 6
Adjusted 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.)
Baseline, Week 6
Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control
Time Frame: Week 4, Week 6
Number 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.)
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
Time Frame: 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
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.
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
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
Time Frame: 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
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.
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
Time Frame: From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
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.
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
Time Frame: From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
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.
From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

July 31, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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