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Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adults Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

NCT01864174•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
•Men and women, aged ≥18 years old at time of enrollment
•Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
•Women must have a negative serum or urine test within 24 hours prior to start of investigational product

Exclusion Criteria

•History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
•Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with \>10% weight loss during last 3 months
•Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40 mg/dL (124 μmol/L for female subjects)

Locations (156)

Central Alabama Research

Birmingham, Alabama, United States

Terence T. Hart, Md

Muscle Shoals, Alabama, United States

Clini Res Advantage Desert Clin Res, Llc

Mesa, Arizona, United States

Clinical Res Advantage Central

Phoenix, Arkansas, United States

Marin Endocrine Care And Research, Inc.

Greenbrae, California, United States

Torrance Clinical Research Institute Inc.

Lomita, California, United States

Actca

Los Angeles, California, United States

National Research Institute

Los Angeles, California, United States

R. Srinivasan, M.D., Inc.

Monterey Park, California, United States

Diabetes Medical Center Of California

Northridge, California, United States

Key Dates

Start Date

June 20, 2013

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

November 29, 2019

Enrollment

1,736

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Metformin XR

DRUG

Metformin IR

DRUG

Placebo matching with Metformin XR

DRUG

Placebo matching with Metformin IR

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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