Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
1 other identifier
interventional
219
4 countries
21
Brief Summary
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Aug 2009
Shorter than P25 for phase_3 type-2-diabetes
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
October 6, 2011
CompletedMay 21, 2015
May 1, 2015
9 months
June 9, 2009
September 2, 2011
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at 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.
Baseline, Week 4
Secondary Outcomes (2)
Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)
Baseline, Week 4
Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal
Baseline, Week 4
Other Outcomes (2)
Participants With Confirmed Hypoglycemia Events During the Treatment Period
AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.
Participants With Reported Hypoglycemic Adverse Events During Treatment Period
AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.
Study Arms (2)
Saxagliptin + Metformin XR + matching Metformin XR placebo
EXPERIMENTAL(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)
Metformin XR + Metformin XR + matching Saxagliptin placebo
ACTIVE COMPARATOR(Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)
Interventions
Tablets, Oral, 5 mg, once daily, 4 weeks
Tablets, Oral, 1500 mg, once daily, 4 weeks
Tablets, Oral, 0 mg, once daily, 4 weeks
Tablets, Oral, 0 mg, once daily, 4 weeks
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- years of age
- Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
- Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- Fasting C-peptide: ≥1.0 ng/mL
- FPG≥126 mg/dl obtained at the Day -7 visit
- Body mass index (BMI): ≤ 40kg/m²
- A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Dedicated Phase I, Inc.
Phoenix, Arizona, 85013, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, 92373, United States
Orange County Research Center
Tustin, California, 92780, United States
Clinical Research Of South Florida
Coral Gables, Florida, 33134, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161, United States
River Birch Research Alliance, Llc
Blue Ridge, Georgia, 30513, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007, United States
Clinilabs, Inc.
New York, New York, 10019, United States
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45212, United States
Clinical Trials Of Texas Inc.
San Antonio, Texas, 78229, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Local Institution
Buenos Aires, Buenos Aires, 1425, Argentina
Local Institution
Capital Federal, Buenos Aires, 1429, Argentina
Local Institution
Beersheba, 84101, Israel
Local Institution
Holon, 58100, Israel
Local Institution
Kfar Saba, 44281, Israel
Local Institution
Safed, 13100, Israel
Local Institution
Durango, Durango, 34000, Mexico
Local Institution
Durango, Durango, 34075, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirschberg
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 11, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 21, 2015
Results First Posted
October 6, 2011
Record last verified: 2015-05