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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00683657
First received: May 21, 2008
Last updated: June 4, 2014
Last verified: June 2014
  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:


Further study details as provided by AstraZeneca:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
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: June 4, 2014
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014