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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

NCT ID: NCT00918138

Last Updated: 2015-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saxagliptin + Metformin XR + matching Metformin XR placebo

(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

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

Metformin XR

Intervention Type DRUG

Tablets, Oral, 1500 mg, once daily, 4 weeks

Placebo matching Metformin XR

Intervention Type DRUG

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

Metformin XR + Metformin XR + matching Saxagliptin placebo

(Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)

Group Type ACTIVE_COMPARATOR

Metformin XR

Intervention Type DRUG

Tablets, Oral, 1500 mg, once daily, 4 weeks

Metformin XR

Intervention Type DRUG

Tablets, Oral, 500 mg, once daily, 4 weeks

Placebo matching Saxagliptin

Intervention Type DRUG

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

Interventions

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Saxagliptin

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

Intervention Type DRUG

Metformin XR

Tablets, Oral, 1500 mg, once daily, 4 weeks

Intervention Type DRUG

Placebo matching Metformin XR

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

Intervention Type DRUG

Metformin XR

Tablets, Oral, 500 mg, once daily, 4 weeks

Intervention Type DRUG

Placebo matching Saxagliptin

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

Intervention Type DRUG

Other Intervention Names

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BMS-477118 Onglyza Glucophage XR® Glucophage XR®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Dedicated Phase I, Inc.

Phoenix, Arizona, United States

Site Status

Pacific Sleep Medicine Services (Avastra Clinical Trials)

Redlands, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Clinical Research Of South Florida

Coral Gables, Florida, United States

Site Status

Palm Springs Research Institute

Hialeah, Florida, United States

Site Status

Healthcare Clinical Data, Inc.

North Miami, Florida, United States

Site Status

River Birch Research Alliance, Llc

Blue Ridge, Georgia, United States

Site Status

Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Site Status

Clinilabs, Inc.

New York, New York, United States

Site Status

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

Site Status

Clinical Trials Of Texas Inc.

San Antonio, Texas, United States

Site Status

Advanced Clinical Research

West Jordan, Utah, United States

Site Status

Local Institution

Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution

Beersheba, , Israel

Site Status

Local Institution

Holon, , Israel

Site Status

Local Institution

Kfar Saba, , Israel

Site Status

Local Institution

Safed, , Israel

Site Status

Local Institution

Durango, Durango, Mexico

Site Status

Local Institution

Durango, Durango, Mexico

Site Status

Local Institution

Monterrey, Nuevo León, Mexico

Site Status

Countries

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United States Argentina Israel Mexico

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CV181-085

Identifier Type: -

Identifier Source: org_study_id

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