A Randomised, Double-blind, Double-dummy, Active-comparator Controlled Study Investigating the Efficacy and Safety of Linagliptin Co-administered With Metformin once a day at Evening Time Versus Metformin twice a day Over 14 Weeks in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Boehringer Ingelheim,0 个研究点目标入组 35 人开始时间: 2011年12月16日最近更新: 2023年9月4日

试验速览

暂无简介。

•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

•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

发起方

Boehringer Ingelheim,