Clinical trial NCT00918138: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* 18-78 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

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

Primary outcomes:
measure: Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)
timeFrame: Baseline, Week 4
measure: Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal
timeFrame: Baseline, Week 4
Other outcomes:
measure: Participants With Confirmed Hypoglycemia Events During the Treatment Period
timeFrame: 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.
measure: Participants With Reported Hypoglycemic Adverse Events During Treatment Period
timeFrame: 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.
Locations:
city: Phoenix
country: United States
facility: Dedicated Phase I, Inc.
state: Arizona
city: Redlands
country: United States
facility: Pacific Sleep Medicine Services (Avastra Clinical Trials)
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Coral Gables
country: United States
facility: Clinical Research Of South Florida
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, Llc
state: Georgia
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
city: San Antonio
country: United States
facility: Clinical Trials Of Texas Inc.
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Beer-Sheva
country: Israel
facility: Local Institution
city: Holon
country: Israel
facility: Local Institution
city: Kfar-Saba
country: Israel
facility: Local Institution
city: Zefat
country: Israel
facility: Local Institution
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Durango
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: