Type 2 Diabetes. MedDRA version: 18.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Glucophage XR (Extended-Release)
Product Name: Metformin hydrochloride
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
Current Sponsor code: BMS2
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must be willing and able to give signed and dated written informed consent. - Subjects with T2DM with inadequate glycemic control on diet and exercise alone (ie, treatment naive defined as no treatment with anti-diabetic antihyperglycemic medication within 90 days prior to enrollment and no more than a total of 14 days with the exception of insulin treatment for gestational diabetes and during periods of hospitalization), defined as central laboratory HbA1c >= 7.0% and = 7.0 and = 7.0% and = 1.0 ng/mL (0.34 nmol/L) at enrollment visit. - BMI == 18 years old at enrollment visit. - Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 1. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half life of the investigational drug is less than 24 hours, contraception should be continued for a period of 30 days after the last dose of investigational product. - Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product. - Women must not be breastfeeding. - Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is less than 24 hours, contraception should be continued for a period of 90 days after the last dose of investigational product. - Women who are not of childbearing potential and azoospermic men do not require contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1295 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 461
Exclusion criteria
Exclusion criteria: - Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with >10% weight loss during last 3 months prior to Visit 1 or other signs and symptoms. - History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma. - Severe uncontrolled hypertension defined as systolic blood pressure (SBP) >= 160 mmHg and/or diastolic blood pressure (DBP) >= 100 mmHg. - Cardiovascular disease within 2 months of the screening visit[ie, myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, stroke or transient ischemic attack (TIA). - Congestive heart failure as New York Heart Association (NYHA) class III or IV. - History of unstable or rapidly progressing renal disease. - Significant hepatic disease, including, but not limited to, chronic hepatitis and/or severe hepatic insufficiency, including subjects with ALT and/or AST > 3x ULN and or total bilirubin > 2 mg/dL. - Moderate or severe impairment of renal function defined as eGFR = 1.50 mg/dL (133 umol/L) for male subjects; serum creatinine >= 1.40 mg/dL (124 umol/L) for female subjects. - Hemoglobin == 3X ULN. - Contraindication to metformin as per local label/prescription information. - Documented history of hepatotoxicity with any medication. - Women who are pregnant. - Prisoners or subjects who are involuntarily incarcerated. - Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. - Administration of any other investigational drug or participation in any interventional clinical studies within 30 days of planned screening to this study. - Subject is a participating investigator, study coordinator, employee of an investigator or immediate family member of any of the aforementioned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if monotherapy with 2000 mg metformin extended release is non-inferior to monotherapy with 2000 mg immediate release in adult patients with type 2 diabetes who have inadequate glycemic control with diet and exercise;Secondary Objective: To compare the effects of metformin XR versus metformin IR after a 24-week double-blind treatment for: - Change from baseline to Week 24 in fasting plasma glucose (FPG) - Change from baseline to Week 24 in Mean Daily Glucose (MDG) - Proportion of subjects achieving a therapeutic glycemic response defined as HbA1c <7.0% at Week 24.;Primary end point(s): To determine if metformin XR monotherapy is non-inferior to metformin IR monotherapy lowering of HbA1c in adult subjects with type 2 diabetes with inadequate glycemic control with diet and exercise. Mean change in HbA1c from baseline to Week 24 in the double-blind treatment period ;Timepoint(s) of evaluation of this end point: 24 Week Double-blind Treatment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - (1A) Mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period. - (1B) Mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period. - (1C) Percent of subjects with HbA1c < 7% at Week 24 in the double-blind treatment period.;Timepoint(s) of evaluation of this end point: 1A: Efficacy measure: change from baseline to Week 24 in fasting plasma glucose. 1B: Efficacy measure: change from baseline to Week 24 in mean daily glucose 1C: Proportion of subjects achieving a therapeutic glycemic response defined as HbA1c < 7.0% at Week 24. | — |
Countries
Canada, Czech Republic, Germany, Hungary, Poland, Puerto Rico, Romania, South Africa, United Kingdom, United States
Contacts
Public ContactEU Study Start-Up Unit
Bristol-Myers Squibb International Corporation
Outcome results
None listed