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

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Saxagliptin Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Saxagliptin

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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:

Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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.

Enrollment:	93
Study Start Date:	July 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683657

Show 27 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00683657 History of Changes
Other Study ID Numbers:	CV181-066, Eudract-2008-000976-26
Study First Received:	May 21, 2008
Results First Received:	February 19, 2010
Last Updated:	November 30, 2010
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Italy: The Italian Medicines Agency United States: Food and Drug Administration Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Finland: Finnish Medicines Agency Finland: Sub-Committee on Medical Research Ethics (TUKIJA) Israel: Ministry of Health Philippines: Bureau of Food and Drugs Philippines: National Ethics Committee Poland: Cental Evidence of Clinical Research

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013