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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01864174
First received: May 24, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Metformin XR
Drug: Metformin IR
Drug: Placebo matching with Metformin XR
Drug: Placebo matching with Metformin IR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24 [ Time Frame: Up to Week 24 (Double-Blind treatment period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in fasting plasma glucose (FPG) from baseline to Week 24 [ Time Frame: Up to Week 24 (Double-Blind treatment period) ] [ Designated as safety issue: No ]
  • Mean change in Mean Daily Glucose (MDG) from baseline to Week 24 [ Time Frame: Up to Week 24 (Double-Blind treatment period) ] [ Designated as safety issue: No ]
  • Percent of subjects with HbA1c <7% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety will be measured by proportion of subjects with adverse events (AEs) and laboratory marked abnormalities [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 524
Study Start Date: June 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Metformin XR and Placebo matching with Metformin XR

Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks

Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks

Drug: Metformin XR
Other Name: Glucophage XR
Drug: Placebo matching with Metformin XR
Active Comparator: Arm 2: Metformin IR and Placebo matching with Metformin IR

Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks

Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks

Drug: Metformin IR
Other Name: Glucophage
Drug: Placebo matching with Metformin IR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864174

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 131 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01864174     History of Changes
Other Study ID Numbers: CV181-206, 2012-004531-23
Study First Received: May 24, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014