Phase 4 Completed N=568 Randomized Double-blind Treatment

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01864174 ↗

Enrolled (actual)

568

Serious AEs

3.2%

Results posted

Jul 2017

Primary outcomePrimary: Adjusted Mean Change From Baseline in HbA1c — -0.93; -0.96 percent

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Mean Change From Baseline in HbA1c	-0.93; -0.96	—
PRIMARY 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	1; 0; 8; 10; 1; 1	—
SECONDARY Mean Change in Fasting Plasma Glucose (FPG)	-21.1; -20.6	—
SECONDARY Mean Change in Mean Daily Glucose (MDG)	-24.68; -27.05	—
SECONDARY Percent of Participants With HbA1c < 7%	70.9; 72.0	—

Eligibility 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)

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Data sourced from ClinicalTrials.gov (NCT01864174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.