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

NCT00683657 | Completed Phase 3 Results

• 2 other identifiers: CV181-066Eudract-2008-000976-26
• Study Type: interventional
• Target: 93
• Locations: 8 countries
• Sites: 27

Brief Summary

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

Conditions

Type 2 Diabetes

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 (4)

• Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4

  Baseline, Week 4

• Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4

  Baseline, Week 4

• Change From Baseline in Mean Daily Glucose at Week 4

  Baseline, Week 4

• Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4

  Baseline, Week 4

Study Arms (2)

Saxagliptin 5 mg + Metformin

EXPERIMENTAL

Drug: Saxagliptin

Placebo + Metformin

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Saxagliptin DRUG

Tablets, Oral, 5mg, once daily, 4 weeks

Also known as: BMS-477118

Saxagliptin 5 mg + Metformin

Placebo DRUG

Tablets, Oral, 0 mg, once daily, 4 weeks

Placebo + Metformin

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (27)

Dedicated Phase I, Inc.

Phoenix, Arizona, 85013, United States

Location

Amcr Institute, Inc

Escondido, California, 92026, United States

Location

Irvine Center For Clinical Research, Inc.

Irvine, California, 92618, United States

Location

Pacific Sleep Medicine Services (Avastra Clinical Trials)

Redlands, California, 92373, United States

Location

Advantage Clinical Research

Santa Ana, California, 92701, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

River Birch Research Alliance, Llc

Blue Ridge, Georgia, 30513, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Covance Cru, Inc.

Portland, Oregon, 97239, United States

Location

Dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

Avastra Clinical Trials

Midvale, Utah, 84047, United States

Location

Local Institution

Martínez, Buenos Aires, B1640AOD, Argentina

Location

Local Institution

Holon, 58100, Israel

Location

Local Institution

Jerusalem, 91120, Israel

Location

Local Institution

Kfar Saba, 44281, Israel

Location

Local Institution

Ẕerifin, 70300, Israel

Location

Local Institution

Milan, 20132, Italy

Location

Local Institution

Aguascalientes, Aguascalientes, 20230, Mexico

Location

Local Institution

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution

Cebu City, 6000, Philippines

Location

Local Institution

Marikina City, 1800, Philippines

Location

Local Institution

Ponce, Puerto Rico, 00717, Puerto Rico

Location

Local Institution

Lund, Sweden, 221 85, Sweden

Location

Local Institution

Gothenburg, 413 45, Sweden

Location

Local Institution

Huddinge, 141 86, Sweden

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boaz Hirschberg
• Organization: AstraZeneca Pharmaceuticals

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 1, 2015
• Results First Posted: March 10, 2010

Record last verified: 2015-05

Locations

PH (2); IT (1); US (13); PR (1); AR (1); IL (4); SE (3); ME (2)