None listed
Conditions
Interventions
IN TOTAL, APPROXIMATELY 1300 PATIENTS WITH T2DM ARE PLANNED FOR INCLUSION IN THIS TRIAL. OF THOSE PATIENTS, 650 ARE PLANNED TO BE TREATMENT NAIVE AND 650 METFORMIN TREATED. THE STUDY IS POWERED FOR EA
7 DAYS FOLLOWING LAST INTAKE OF TRIAL MEDICATION. AFTER TRIAL COMPLETION ALL AEs, INCLUDING THOSE PERSISTING, ARE FOLLOWED-UP FOR UP TO 30 DAYS AND IT SHOULD BE CONFIRMED IF THEY HAVE RESOLVED OR BEE
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. DIAGNOSIS OF TYPE 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) OR PRE-TREATED WITH METFORMIN (≥ 1500 mg/day OR ON THE MAXIMUM TOLERATED DOSE OR THE MAXIMUM DOSE ACCORDING TO LOCAL LABEL) UNCHANGED FOR 12 WEEKS PRIOR TO RANDOMISATION. 3. HbA1c ≥ 7.0% and ≤ 10.5% (≥ 53.0 mmol/mol and ≤ 91.3 mmol/mol) AT VISIT 1 (SCREENING). 4. AGE ≥ 18 YEARS. 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/dl (> 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 OTHER ANTIDIABETIC DRUG WITHIN 12 WEEKS PRIOR TO RANDOMIZATION (EXCEPT METFORMIN BACKGROUND THERAPY AS DEFINED VIA INCLUSION CRITERION 2). 3. ACUTE CORONARY SYNDROME (NON-STEMI, STEMI AND UNSTABLE ANGINA PECTORIS) STROKE OR 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 UN-IN PERIOD. 5. IMPAIRED RENAL FUNCTION, DEFINED AS eGFR <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) AND/OR TREATMENT FOR CANCER WITHIN THE LAST 5 YEARS.
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, Estonia, Hungary, Italy, Lebano, Malasya, Mexico, Philippines, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed