EUCTR2012-002309-23-PL进行中（未招募）不适用
A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 748
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject has T2DM and must be =18 of age on the day of signing the
- •informed consent form. For India: subject has T2DM and is =18 and =65
- •years of age.
- •2. Subject is on a stable dose of metformin (=1500 mg/day) for at least
- •12 weeks with inadequate glycemic control, i.e., A1C =6.5% (48
- •mmol/mol) and =9.0%.% (75 mmol/mol).
- •3. Subject meets one of the following criteria:
- •a. Subject is a male
- •b. Subject is a female not of reproductive potential defined as one who
- •has either:
- •(1) reached natural menopause (defined as 12 months of spontaneous
- •amenorrhea in women >45 years of age, or 6 months of spontaneous
- •amenorrhea with serum follicular stimulating hormone [FSH] levels in
- •the postmenopausal range as determined by the laboratory), or
- •(2) had a hysterectomy and/or bilateral oophorectomy, or had bilateral
- •tubal ligation or occlusion at least 6 weeks prior to screening.
- •c. Subject is a female of reproductive potential and:
- •(1) agrees to remain abstinent from heterosexual activity (if this form of
- •birth control is accepted by local regulatory agencies and ethics review
- •committees as the sole method of birth control), or
- •(2) agrees to use (or have their partner use) acceptable contraception to
- •prevent pregnancy within the projected duration of the trial and for 21
- •days after the last dose of blinded study medication. Two methods of
- •contraception will be used to avoid pregnancy. Acceptable combinations
- •of methods include:
- •- Use of one of the following double-barrier methods: diaphragm with
- •spermicide and a condom; cervical cap and a condom; or contraceptive
- •sponge and a condom.
- •- Use of hormonal contraception (any registered and marketed
- •contraceptive agent that contains an estrogen and/or a progestational
- •agent [including oral, subcutaneous, intrauterine and intramuscular
- •agents, and cutaneous patch]) with one of the following: diaphragm with
- •spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or
- •intrauterine device (IUD).
- •- Use of an IUD with one of the following: condom; diaphragm with
- •spermicide; contraceptive sponge; vasectomy; or hormonal
- •contraception (see above).
- •-Vasectomy with one of the following: diaphragm with spermicide;
- •cervical cap; contraceptive sponge; condom; IUD; or hormonal
- •contraception (see above).
- •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 (as determined by site performed capsule count).
- •Subject has 85% compliance with glimepiride placebo treatment during the singleblind run-in period (as determined by site performed capsule count).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- 另有 4 项未显示
排除标准
- •1. Subject has a history of T1DM or a history of ketoacidosis. OR is assessed by the investigator as possibly having T1DM confirmed with a
- •C-peptide <0.7 ng/mL
- •2. Subject has been treated with any AHA therapies other than the
- •protocol-required metformin within the prior 12 weeks of
- •V1/Screening or with MK-3102 at any time prior to signing informed
- •3. Subject has a history of hypersensitivity to a DPP-4 inhibitor.
- •4. Subject is currently participating in, or has participated, in a trial in
- •which the subject received an investigational compound or used an
- •investigational device within the prior 12 weeks of signing the informed
- •5. Subject has a history of intolerance or hypersensitivity to glimepiride,
- •or insulin glargine or any contraindication to metformin, glimepiride, or
- •insulin glargine based upon the label in the country of the investigational
- •6. Subject is on a weight loss program and is not in the maintenance
- •phase; has been on a weight loss medication in the past 6 months; or
- •has undergone bariatric surgery within 12 months prior to signing the
- •informed consent.
- •7. Subject has undergone a surgical procedure within 4 weeks prior to
- •signing informed consent
- •8. Subject is on or likely to require treatment for =14 consecutive days
- •or repeated courses of corticosteroids.
- •9. Subject is currently being treated for hyperthyroidism or subject is on
- •thyroid replacement therapy and has not been on a stable dose for at
- •least 6 weeks.
- •10. Subject is currently on or likely to require treatment with a
- •prohibited medication
- •11. Subject has a medical history of active liver disease including chronic
- •active hepatitis B or C primary biliary cirrhosis, or symptomatic
- •gallbladder disease.
- •12. Subject has HIV as assessed by medical history.
- •13. Subject has had new or worsening signs or symptoms of CHD or CHF
- •within the past 3 months, or has any of the following disorders within
- •the past 3 months: Acute coronary syndrome, Coronary artery
- •intervention, Stroke or transient ischemic neurological disorder
- •14. Subject has poorly controlled hypertension and blood pressure is
- •unlikely to be within these limits by Visit 2/Week -2 with an adjustment
- •in antihypertensive medication.
- •15. Subject has a history of malignancy =5 years prior to signing
- •informed consent, except for adequately treated basal cell or squamous
- •cell skin cancer, or in situ cervical cancer.
- •16. Subject has a clinically important hematological disorder
- •17. Subject has exclusionary laboratory values as listed in protocol
- •18. Subject has a positive urine pregnancy test (At screening)
- •19. Subject is pregnant or breast-feeding, or is expecting to conceive
- •during the trial, including 21 days following the last dose of blinded
- •study medication. Or Subject is expecting to undergo hormonal therapy
- •in preparation to donate eggs during the period of the trial, including 21
- •days following the last dose of blinded study medication.
- •20. Subject is, at the time of signing informed consent, a user of
- •recreational or illicit drugs or has had a recent history of drug abuse.
- •Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic
- 另有 7 项未显示
研究者
相似试验
进行中（未招募）
不适用
A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) compared with the addition of a licensed drug Glimepiride) in patients with Type 2 Diabetes.MedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2013-000301-23-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.680
进行中（未招募）
1 期
A Study of Sitagliptin in Pediatric Patients with Type 2 Diabetes MellitusMedDRA version: 20.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000072461Type 2 Diabetes MellitusEUCTR2011-002528-42-LTMerck Sharp & Dohme Corp. A subsidiary of Merck & Co. Inc200
进行中（未招募）
不适用
A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) compared with the addition of a licensed drug Glimepiride) in patients with Type 2 Diabetes.MedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2013-000301-23-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.680
进行中（未招募）
不适用
A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) compared with the addition of a licensed drug Glimepiride) in patients with Type 2 Diabetes.Type 2 Diabetes MellitusEUCTR2013-000301-23-ATMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.680
进行中（未招募）
不适用
A Phase III, Multicenter, Double-Blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly with 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis as Assessed at 12 and 24 Months. 2005032 (EFC6062) (HMR4003K/3001) - MERIT-OPOsteoporosis in post-menopausal womenMedDRA version: 7.0Level: PTClassification code 10031285EUCTR2005-002785-10-HUProcter & Gamble Pharmaceuticals Inc1,068