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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

Safety and Efficacy Study of Subjects that are taking saxagliptin added onto metformin XR compared to subjects taking metformin XR alone

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Dgd Research, Inc.

Local Institution

Amcr Institute, Inc

Covance Cru, Inc.

Avastra Clinical Trials

Jasper Clinic, Inc.

Orange County Research Center

Dedicated Phase I, Inc.

Pacific Sleep Medicine Services (Avastra Clinical Trials)

Advantage Clinical Research

Endocrine Research Solutions, Inc.

River Birch Research Alliance, Llc

Irvine Center For Clinical Research, Inc.

Clinilabs, Inc.

A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/day

AgeCategoricalOther

AgeContinuous

GenderNIH

RaceEthnicityOther

Baseline Mean

Week 4 Mean

Adjusted Mean Change from Baseline

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.

With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin
and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.

Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at 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 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4

Adjusted Change from Baseline

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 2-Hour Postprandial Plasma Glucose After the Evening Meal at 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 Mean Daily Glucose at Week 4

Week 4 Last Observation Carried Forward Mean

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.

Change from Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4

Overall Study

218 subjects were enrolled and 128 entered the 4-week dietary and exercise, and metformin extended release (XR) lead-in period. Thirty-five subjects did not enter treatment period (21 no longer met study criteria, 7 withdrew consent, 7 for poor protocol compliance).

Arms	Assigned Interventions
Experimental: Saxagliptin 5 mg + Metformin	Drug: Saxagliptin Tablets, Oral, 5mg, once daily, 4 weeks Other Name: BMS-477118
Placebo Comparator: Placebo + Metformin	Drug: Placebo Tablets, Oral, 0 mg, once daily, 4 weeks

Safety and Efficacy Study of Subjects that are taking saxagliptin added onto metformin XR compared to subjects taking metformin XR alone

Official Title

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Documents available

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

CSR synopsis, posted to PhRMA website

Trial Results Summaries

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