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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864174
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : July 21, 2017
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE May 29, 2013
Results First Submitted Date  ICMJE May 31, 2017
Results First Posted Date  ICMJE July 21, 2017
Last Update Posted Date November 28, 2019
Actual Study Start Date  ICMJE June 20, 2013
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • Adjusted Mean Change From Baseline in HbA1c [ Time Frame: Baseline and Week 24 ]
    Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.
  • Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation [ Time Frame: Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks) ]
    SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24 [ Time Frame: Up to Week 24 (Double-Blind treatment period) ]
Change History Complete list of historical versions of study NCT01864174 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 24 ]
    The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG > 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter
  • Mean Change in Mean Daily Glucose (MDG) [ Time Frame: Baseline and Week 24 ]
    The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.
  • Percent of Participants With HbA1c < 7% [ Time Frame: Week 24 ]
    Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
  • Mean change in fasting plasma glucose (FPG) from baseline to Week 24 [ Time Frame: Up to Week 24 (Double-Blind treatment period) ]
  • Mean change in Mean Daily Glucose (MDG) from baseline to Week 24 [ Time Frame: Up to Week 24 (Double-Blind treatment period) ]
  • Percent of subjects with HbA1c <7% [ Time Frame: Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2013)
Safety will be measured by proportion of subjects with adverse events (AEs) and laboratory marked abnormalities [ Time Frame: Up to Week 24 ]
 
Descriptive Information
Brief Title  ICMJE Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Metformin XR
    Other Name: Glucophage XR
  • Drug: Metformin IR
    Other Name: Glucophage
  • Drug: Placebo matching with Metformin XR
  • Drug: Placebo matching with Metformin IR
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Metformin 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

    Interventions:
    • Drug: Metformin IR
    • Drug: Placebo matching with Metformin IR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2017)
1736
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2013)
524
Actual Study Completion Date  ICMJE June 1, 2016
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Germany,   Hungary,   Poland,   Puerto Rico,   Romania,   South Africa,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01864174
Other Study ID Numbers  ICMJE CV181-206
2012-004531-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP