PER-083-11未知未知
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
Boehringer Ingelheim,0 个研究点目标入组 52 人开始时间: 2011年11月10日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
入选标准
- •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.
排除标准
- •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.
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