None listed
Conditions
Interventions
IN TOTAL, APPROXIMATELY 555 PATIENTS WITH TYPE 2 DIABETES WHO MEET THE ENTRY CRITERIA ARE PLANNED TO BE RANDOMIZED TO THIS TRIAL (185 IN EACH TREATMENT GROUP). THE RANDOMIZED TREATMENT WILL BE ADMINIS
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. DIAGNOSIS OF T2DM PRIOR TO INFORMED CONSENT. 2. MALE AND FEMALE PATIENTS ON DIET AND EXERCISE REGIMEN WHO ARE PRE-TREATED WITH MULTIPLE DAILY INJECTIONS (MDI) OF INSULIN ALONE OR IN COMBINATION WITH IMMEDIATE OR EXTENDED RELEASE METFORMIN. INSULIN THERAPY MUST INCLUDE BOTH BASAL AND PRANDIAL INSULIN. ANY TYPE OF BASAL AND ANY TYPE OF PRANDIAL INSULIN ARE ALLOWED. PRE-MIXED INSULIN PREPARATIONS ARE NOT ALLOWED. 3. TOTAL PRESCRIBED INSULIN DOSE MUST BE > 60 IU/DAY AT VISIT 1 (SCREENING) AND SHOULD NOT BE CHANGED WITHIN 12 WEEKS PRIOR RANDOMIZATION BY MORE THAN 10% FROM THE BASELINE VALUE AT RANDOMIZATION (VISIT 3). 4. STABLE METFORMIN THERAPY: • DAILY DOSE ≥1500 MG/DAY OR MAXIMUM TOLERATED DOSE (MUST BE DOCUMENTED) OR MAXIMUM DOSE ACCORDING TO THE LOCAL LABEL. • THE METFORMIN DOSE HAS TO BE UNCHANGED FOR 12 WEEKS BEFORE THE RANDOMIZATION (VISIT 3). 5. HbA1c ≥ 7.5% AND <10% AT VISIT 1 (SCREENING) 6. AGE ≥ 18 AND <80 YEARS AT VISIT 1 (SCREENING) 7. BODY MASS INDEX (BMI) ≥ 30 AND <45 KG/M² AT VISIT 1 (SCREENING) 8. 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/dl (> 13.3 mmol/l) AFTER AN OVERNIGTH FAST DURING PLACEBO RUN-IN AND CONFIRMED BY SECOND MEASUREMENT (NOT ON THE SAME DAY). 2. ANY OTHER ANTIDIABETIC DRUG WITHIN 12 WEEKS PRIOR TO RANDOMIZATION EXCEPT THOSE MENTIONED IN INCLUSION CRITERION 2. 3. ACUTE CORONARY SYNDROME (NON-STEMI, STEMI AND UNSTABLE ANGINA PECTORIS) STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA) WITHIN 3 MONTHS PRIOR TO THE INFORMED CONSENT. 4. INDICATION OF LIVER DISEASE, DEFINED BY SERUM LEVELS OF EITHER ALANINE TRANSAMINASE (ALT, SGPT), ASPARTATE TRANSAMINASE (AST, SGOT) OR ALKALINE PHOSPHATASE ABOVE 3 TIMES UPPER LIMIT OF NORMAL (ULN) AS DETERMINED DURING SCREENING OR RUN-IN PERIOD. 5. IMPAIRED RENAL FUNCTION, DEFINED AS GFR <60 ml/min (MDRD 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) OR TREATMENT FOR CANCER WITHIN THE LAST 5 YEARS.
Countries
Belgium, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, Guatemala, Mexico, Peru, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed