None listed
Conditions
Interventions
IN TOTAL, APPROXIMATELY 1424 PATIENTS WITH T2DM WHO MEET THE ENTRY CRITERIA ARE PLANNED TO BE TREATED IN THIS TRIAL. OF THESE, APPROXIMATELY 1344 ARE PLANNED TO BE RANDOMIZED TO DOUBLE BLIND TREATMENT
7.0 TO ≤
10.0% (≥
53.0 MMOL/MOL TO ≤
85.8 MMOL/MOL) WILL UNDERGO A 2 WEEK SINGLE-BLINDED PLACEBO RUN-IN PERIOD BEFORE RANDOMIZATION (FIGURE 3.1: 1). PATIENTS WHO SUCCESSFULLY COMPLETE THIS PERIOD AND WHO STILL MEET THE INCLUSION/EXCLUSIO
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. DIAGNOSIS OF TYPE 2 DIABETES MELLITUS PRIOR TO INFORMED CONSENT 2. MALE AND FEMALE PATIENTS ON DIET AND EXERCISE REGIMEN WHO ARE DRUG-NAIVE, DEFINED AS ABSENCE OF ANY ORAL ANTIDIABETIC THERAPY, GLP-1 ANALOG OR INSULIN FOR 12 WEEKS PRIOR TO RANDOMIZATION 3. HBALC A. ≥ 7.0% AND ≤ 10% (≥ 53.0 MMOL/MOL AND ≤ 85.8 MMOL/MOL) AT VISIT 1 (SCREENING) TO BE ELIGIBLE FOR RANDOMIZED TREATMENT B. > 10.0% (>85.8 MMOL/MOL) AT VISIT 1 (SCREENING) TO BE ELIGIBLE FOR THE OPEN-LABEL ARM 4. AGE ≥ 18 5. BODY MASS INDEX (BMI) ≤ 45 KG/M2 AT VISIT 1 (SCREENING) 6. SIGNED AND DATED WRITTEN INFORMED CONSENT BY DATE OF VISIT 1 IN ACCORDANCE WITH GCP AND LOCAL LEGISLATION
Exclusion criteria
Exclusion criteria: 1. UNCONTROLLED HYPERGLYCEMIA WITH A GLUCOSE LEVEL >240 MG/DI (>13.3 MMOL/L) AFTER AN OVERNIGHT FAST DURING PLACEBO RUN-IN AND CONFIRMED BY A SECOND MEASUREMENT (NOT ON THE SAME DAY) 2. ANY ANTIDIABETIC DRUG WITHIN 12 WEEKS PRIOR TO RANDOMIZATION 3. ACUTE CORONARY SYNDROME (NON-STEMI, STEMI AND UNSTABLE ANGINA PECTORIS), STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA) WITHIN 3 MONTHS PRIOR TO INFORMED CONSENT 4. INDICATION OF LIVER DISEASE, DEFINED BY SERUM LEVELS OF EITHER ALT (SGPT), AST (SGOT), OR ALKALINE PHOSPHATASE ABOVE 3 X UPPER LIMIT OF NORMAL (ULN) AS DETERMINED DURING SCREENING AND/OR RUN-IN PERIOD 5. IMPAIRED RENAL FUNCTION, DEFINED AS ESTIMATED CREATININE CLEARANCE RATE (ECCR) <60 ML/MIN (COCKCROFT-GAULT FORMULA) AS DETERMINED DURING SCREENING AND/OR RUN-IN PERIOD 6. BARIATRIC SURGERY WITHIN THE PAST TWO YEARS AND OTHER GASTROINTESTINAL SURGERIES THAT INDUCE CHRONIC MALABSORPTION 7. MEDICAL HISTORY OF CANCER (EXCEPT FOR BASAL CELL CARCINOMA) AND/OR TREATMENT FOR CANCER WITHIN THE LAST 5 YEARS 8. KNOWN BLOOD DYSCRASIAS OR ANY DISORDERS CAUSING HEMOLYSIS OR UNSTABLE RED BLOOD CELL (E.G. MALARIA, BABESIOSIS, HEMOLYTIC ANEMIA) 9. CONTRAINDICATIONS TO METFORMIN ACCORDING TO THE LOCAL LABEL
Countries
Brazil, Canada, Czech Republic, Egypt, France, Germany, Guatemala, India, Korea North, Lebano, Malasya, Mexico, Peru, Philippines, Spain, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactLUIS MELENDEZ
PPD Peru S.A.C.
Outcome results
None listed