Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo
Drug: Saxagliptin

Registration Number: NCT00683657

Lead Sponsor: AstraZeneca

Brief Summary: This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 93

Inclusion Criteria

≥18- and ≤77-years-old
Type 2 diabetes
Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
Glycosylated hemoglobin (A1C) ≥7% and ≤10%
Body mass index (BMI) ≤40 kg/m2

Exclusion Criteria

Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
Significant cardiovascular history
Active liver disease
Renal impairment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Metformin	Placebo	-
Saxagliptin 5 mg + Metformin	Saxagliptin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4	Baseline, Week 4	Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4	Baseline, Week 4	Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4	Baseline, Week 4	Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Change From Baseline in Mean Daily Glucose at Week 4	Baseline, Week 4	Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4	Baseline, Week 4	Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.

Trial Locations

Locations (14): Dedicated Phase I, Inc.
🇺🇸
Phoenix, Arizona, United States
Amcr Institute, Inc
🇺🇸
Escondido, California, United States
Irvine Center For Clinical Research, Inc.
🇺🇸
Irvine, California, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
🇺🇸
Redlands, California, United States
Advantage Clinical Research
🇺🇸
Santa Ana, California, United States
Orange County Research Center
🇺🇸
Tustin, California, United States
River Birch Research Alliance, Llc
🇺🇸
Blue Ridge, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸
Roswell, Georgia, United States
Jasper Clinic, Inc.
🇺🇸
Kalamazoo, Michigan, United States
Clinilabs, Inc.
🇺🇸
New York, New York, United States
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Dedicated Phase I, Inc.
🇺🇸Phoenix, Arizona, United States