A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF THE ADDITION OF MK-3102 TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL ON METFORMIN THERAPY

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,0 个研究点目标入组 0 人开始时间: 2013年10月21日最近更新: 2023年9月4日

适应症

试验速览

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•1. Subject has T2DM, and must be ≥18 years of age on the day of signing the informed consent form. 2. Subject is on metformin monotherapy at a stable dose of metformin (≥1500 mg/day) for at least 12 weeks and has an A1C ≥7% and ≤10.5%.3. Subject meets one of the following criteria:a. Subject is a maleb. Subject is a female not of reproductive potential c. Subject is a female of reproductive potential and: 1) Agrees to remain abstinent from heterosexual activity OR2) Agrees to use (or her partner to use) adequate contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded study medication. Adequate methods of contraception 4. Subject understands the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.5. Subject has 100% compliance with MK-3102 placebo treatment during the single blind run-in period .

•1.Patient is younger than 18 years old. 2 Patient has type 2 diabetes is adequately controlled with metformin.3 .Patient has type 1 diabetes mellitus or ketoacidosis (a complication associated with diabetes mellitus in which your body produces very high levels of blood acids called ketones).4 . Patient has taken or will require medications that are not allowed in this study.5. Patient is allergic to one of the study drugs or you cannot be given the study drug according to the label in your country.6. Patient has participated in a study with an experimental drug or device within the past 12 weeks or you are planning to participate in a study with an experimental drug or device during this study. 7. Patient is on a weight-loss program, have started a weight-loss medication, or you have undergone bariatric surgery (weight loss surgery) within the past 12 months.8. Patient has a medical condition, illness, or symptom that could affect your safety or the study results.9.Patient is pregnant or breastfeeding or planning to become pregnant/breastfeed during the study. 10. Patient is planning to receive hormone medications in preparation to donate your own eggs during this study, including within the 21 days after you receive your last dose of study drug.11. Patient use illegal drugs or is dependent on alcohol.
•More specification can be found in the Exclusion Criteria Section in the Protocol

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,