PER-062-11未知未知
A 66-WEEK EXTENSION TO: A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTRO
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2011年9月30日最近更新:
试验速览
- 阶段
- 未知
- 发起方
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
- 70 至 18（—）
入选标准
- •1. COMPLETE THE DOUBLE-BLIND BASE STUDY (WITH OR WITHOUT INIATIATION OF GLYCEMIC RESCUE MEDICATION WITH OPEN-LABEL METFORMIN).
- •2. HAVE ≥ 75% COMPLIANCE WITH DOUBLE-BLIND STUDY MEDICATION DURING THE BASE STUDY DOUBLE-BLIND TREATMENT PERIOD.
- •3. UNDERSTAND THE EXTENSION STUDY PROCEDURES AND AGREE TO PARTICIPATE IN THE EXTENSION BY GIVING WRITTEN INFORMED CONSENT.
- •4. WOMEN OF CHILDBEARING POTENTIAL MUST CONTINUE TO COMPLY WITH THE PROTOCOL- SPECIFIED CONTRACEPTIVE METHODS AS PREVIOUSLY OUTLINED IN THE BASE STUDY.
排除标准
- •1. PATIENT HAS A HISTORY OF INTOLERANCE OR ANY CONTRAINDICATION FOR THE USE OF PIOGLITAZONE OR METFORMIN DESCRIBED IN THE PACKAGE INSERT FROM THE COUNTRY OF THE INVESTIGATIONAL SITE.
- •2. PATIENT MEETS ANY OF THE BASE STUDY CRITERIA FOR DISCONTINUATION FROM THE STUDY DRUG.
- •3. PATIENT HAS CONGESTIVE HEART FAILURE (NYHA 1-IV).
- •4. PATIENT REQUIRES OR IS LIKELY TO REQUIRE THERAPY WITH GEMFIBROZIL OR OTHER STRONG CYP2C8 INHIBITORS.
- •5. PATIENT HAS EXCLUSIONARY LABORATORY VALUES BASED ON THE CENTRAL LAB RESULTS FROM THE LAST VISIT PRIO TO THIS AMENDMENT BEING APPROVED (OR FROM VISIT 7 FOR THOSE PATIENTS NOT ALREADY ENTERED INTO THE EXTENSION) AS LISTED IN TABLE THE 2-1 BELOW.
- •6. PATIENT HAS BLADDER CANCER OR HAS A HISTORY OF BLADDER CANCER.
研究者
相似试验
进行中（未招募）
不适用
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding, Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control. (Original Study EudraCT # 2010-022193-13)Type 2 Diabetes MellitusEUCTR2011-000656-42-FIMSD Finland Oy510
进行中（未招募）
1 期
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic ControlMedDRA version: 13.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2010-022193-13-LVMerck Sharp & Dohme Corp.663
进行中（未招募）
不适用
.A.Type 2 Diabetes MellitusEUCTR2011-000656-42-LTMerck Sharp & Dohme Corp.663
进行中（未招募）
不适用
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic ControlType 2 Diabetes MellitusEUCTR2010-022193-13-DKMerck Sharp & Dohme Corp.600
进行中（未招募）
不适用
A 66 week extension to:A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic ControlMedDRA version: 13.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2010-022193-13-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.663