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

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ClinicalTrials.gov Identifier: NCT00683657
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : March 10, 2010
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

May 21, 2008
May 23, 2008
February 19, 2010
March 10, 2010
June 1, 2015
July 2008
February 2009   (Final data collection date for primary outcome measure)
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 [ Time Frame: 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.
Change in 24-hour mean weighted glucose from baseline to Week 4 [ Time Frame: Day 28 ]
Complete list of historical versions of study NCT00683657 on ClinicalTrials.gov Archive Site
  • Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Change from baseline to Week 4 in 4-hour mean weighted postprandial glucose [ Time Frame: Day 28 ]
  • Change from baseline to Week 4 in 2-hour postprandial plasma glucose after the evening meal [ Time Frame: Day 28 ]
  • Change from baseline to Week 4 in mean daily glucose (calculated as 7 daily, finger stick glucose measurements collected at home in a 3-day period, prior to the collection of 24-h blood samples) [ Time Frame: Day 28 ]
  • Change from baseline to Week 4 in fasting plasma glucose (FPG) [ Time Frame: Day 28 ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
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
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Saxagliptin
    Tablets, Oral, 5mg, once daily, 4 weeks
    Other Name: BMS-477118
  • Drug: Placebo
    Tablets, Oral, 0 mg, once daily, 4 weeks
  • Experimental: Saxagliptin 5 mg + Metformin
    Intervention: Drug: Saxagliptin
  • Placebo Comparator: Placebo + Metformin
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
92
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 77 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Israel,   Italy,   Mexico,   Philippines,   Puerto Rico,   Sweden,   United States
 
 
NCT00683657
CV181-066
Eudract-2008-000976-26
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP