A PHASE III RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE DAILY ORAL ADMINISTRATION OF BI 10773 25 MG/LINAGLIPTIN 5 MG AND BI 10773 10 MG/LINAGLIPTIN 5 MG FIXED DOSE COMBINATION TABLETS COMPARED WITH THE INDIVIDUAL COMPONENTS (BI 10773 25 MG, BI 10773 10 MG, AND LINAGLIPTIN 5 MG) FOR 52 WEEKS IN TREATMENT NAÏVE AND METFORMIN TREATED PATIENTS WITH TYPE 2 DIABETES MELLITUS WITH INSUFFICIENT GLYCAEMIC CONTRO
- Registration Number
- PER-083-11
- Lead Sponsor
- Boehringer Ingelheim,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 52
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method