Clinical trial NCT00683657: Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

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 in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Mean Daily Glucose at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dedicated Phase I, Inc.
state: Arizona
city: Escondido
country: United States
facility: Amcr Institute, Inc
state: California
city: Irvine
country: United States
facility: Irvine Center For Clinical Research, Inc.
state: California
city: Redlands
country: United States
facility: Pacific Sleep Medicine Services (Avastra Clinical Trials)
state: California
city: Santa Ana
country: United States
facility: Advantage Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, Llc
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
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: Portland
country: United States
facility: Covance Cru, Inc.
state: Oregon
city: San Antonio
country: United States
facility: Dgd Research, Inc.
state: Texas
city: Midvale
country: United States
facility: Avastra Clinical Trials
state: Utah
city: Martinez
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Holon
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Kfar-Saba
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Cebu City
country: Philippines
facility: Local Institution
city: Marikina City
country: Philippines
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Huddinge
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: