None listed
Conditions
Interventions
THIS STUDY IS MADE TO COMPARE THE EFFICACY AND SAFETY OF LINAGLIPTIN (5 mg) ADMINISTERED CONCOMITANTLY WITH METFORMIN ONCE A DAY (MAX DOSE. DAILY 1000 mg) BEDTIME WITH METFORMIN TWICE A DAY (MAX DOSE.
2000 mg IN GROUP OF TWICE A DAY) IN TERM OF 2 WEEKS ADMINISTER METFORMIN AND THEN FOLLOWING WITHOUT CHANGE THE DOSAGE DURING 12 WEEKS OF TREATMENT TIME. DURING THE TITRATION PERIOD OF 2 WEEKS, THE TIT
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. DIAGNOSIS OF INFORMED CONSENT BEFORE T2DM 2. MALE AND FEMALE PATIENTS WITH FOOD AND EXERCISE REGIME WHICH HAVE NOT RECEIVED PRIOR DRUG TREATMENT, DEFINED AS THE ABSENCE OF ANY ORAL DRUG ANTIDIABETIC (CAD) OR INSULIN FOR AT LEAST 12 WEEKS PRIOR TO RANDOMIZATION 3. HbA1c ≥ 6.5% (48 mmol/mol) and ≤ 10.0% (86 mmol/mol) DURING THE VISIT 1 (SELECT) 4. AGE ≥ 18 AND ≤ 80 YEARS IN BUSINESS 1 (SELECT) 5. BMI (BODY MASS INDEX) ≤ 45 kg/m DURING THE VISIT 1 (SELECT) 6. INFORMED CONSENT IN WRITING SIGNED AND DATED TO THE DATE OF VISIT 1ST AND AGREEMENT WITH LOCAL LAW GCP
Exclusion criteria
Exclusion criteria: 1. UNCONTROLLED HYPERGLYCEMIA WITH GLUCOSE LEVEL> 240 mg/dl (> 13.3 mmol/l) FAST AFTER NIGHT IN THE SELECTION / placebo run AND CONFIRMED BY A SECOND MEASUREMENT (NOT MADE THE SAME DAY) 2. ANTIDIABETIC DRUG TREATMENT WITH ORAL OR ANY INSULIN IN 12 WEEKS PRIOR TO RANDOMIZATION 3. ACUTE CORONARY SYNDROME (HEART ATTACK ST SEGMENT ELEVATION WITHOUT ST SEGMENT ELEVATION AND UNSTABLE ANGINA) STROKE OR TIA WITHIN 3 MONTHS PRIOR TO THE INFORMED CONSENT 4. INDICATION OF LIVER DISEASE / LIVER DYSFUNCTION, SERUM LEVELS DEFINED ALT (SGPT), AST (SGOT) ALKALINE PHOSPHATASE OR 3 TIMES ABOVE NORMAL HIGH LIMIT (UPPER LIMIT OF NORMAL, ULN) AS DETERMINED IN THE SELECTION AND/OR IN PHASE 5. RENAL DYSFUNCTION, DEFINED AS ESTIMATED GFR <60 ml/min (MDRD FORMULA) AS DETERMINED IN THE SELECTION OR IN PHASE 6. BARIATRIC SURGERY WITHIN THE LAST TWO YEARS AND OTHER GASTROINTESTINAL SURGERY THAT INDUCE CHRONIC MALABSORPTION 7. CANCER MEDICAL HISTORY (EXCEPT BASAL CELL CARCINOMA) AND / OR CANCER TREATMENT WITHIN THE LAST 5 YEARS
Countries
Bangladesh, Belgium, Canada, China, Germany, Guatemala, India, Lebano, Mexico, Peru, Philippines, Spain, Taiwan
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed