EUCTR2012-003626-24-BG进行中（未招募）不适用
A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
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
- 300
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 years of age (for India: =18 and =65 years of age) on the day of signing the informed consent form.
- •2. Subject meets one of the following criteria:
- •a. Subject is currently not on an AHA (off AHA therapies for =12 weeks) and has a Visit 1/Screening Visit A1C =7.0 and =10.0%.
- •b. Subject is currently on a stable dose for > 12 weeks of a single AHA or low-dose dual oral AHA
- •combination therapy (i.e., =50% maximum labeled dose of each agent [except thiazolidinediones (TZDs)]) and has a Visit 1/ Screening Visit A1C =6.5 and =9.0% AND based upon review of the
- •subject’s current diet, medical regimen, and Visit 1 A1C, subject is considered by the investigator
- •to be likely to meet Visit 3/Week -2 inclusion criterion of A1C =7.0 and =10.0% AFTER the 8-week
- •wash-off period prior to Visit 3/Week-2 (Visit 2/Week -10 to Visit 3/ Week -2).
- •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
- •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
- •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 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
- •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, 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 an A1C of =7.0% and =10.0% within 2 weeks of Visit 3/Week -2.
- •Note: If the A1C is not within the Visit 3 A1C inclusion criterion, a single repeat measurement
- •maybe performed at the discretion of the investigator. If repeat value meets Visit 3 A1C inclusion criterion, subject
排除标准
- •1.Subject has a history of type 1 diabetes mellitus or a history of
- •ketoacidosis or is assessed by the investigator as possibly having type 1
- •diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L)
- •2.has been treated with:
- •a.thiazolidinedione (TZD) within 4 months of signing informed consent,
- •b.GLP-1 receptor mimetic or agonist or DPP-4 inhibitors within 6 months of signing informed consent, or
- •c.insulin or sodium-glucose cotransporter (SGLT2) inhibitor within 12 weeks prior to signing informed consent
- •d.MK-3102 at any time prior to signing informed consent
- •3.has a history of hypersensitivity to a DPP-4 inhibitor
- •4.is currently participating in/has participated in another trial with an investigational compound or device within the prior 12 weeks of signing the informed consent and does not agree to refrain from participating in any other trial
- •5.has a history of intolerance,hypersensitivity or any contraindication to metformin (in Phase A),glimepiride or other sulfonyurea (in Phase B) based upon the label in the country of the investigational site
- •6.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.has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial
- •8.Subject is on or likely to require treatment for =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
- •9.is currently being treated for hyperthyroidism or subject is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
- •10.is currently on or likely to require treatment with a prohibited
- •11.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
- •12.has a medical history of active liver disease,including chronic active hepatitis B or C,primary biliary cirrhosis, or symptomatic gallbladder disease
- •13.has HIV as assessed by medical history
- •14.has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months,or has any of the following disorders within the past 3 months:
- •a.Acute coronary syndrome
- •b.Coronary artery intervention
- •c.Stroke or transient ischemic neurological disorder
- •15.has poorly controlled hypertension defined as systolic blood pressure of =160 mm Hg or diastolic blood pressure of =90 mm Hg
- •16.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
- •17.has a clinically important hematological disorder
- •18.has exclusionary laboratory values (as per protocol)
- •19.has a positive urine pregnancy test
- •20.is pregnant or breast-feeding,or is expecting to conceive during the trial,including 21 days following the last dose of blinded study medication
- •21.is a user of recreational or illicit drugs or has had a recent history of drug abuse
- •22.routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week,or engages in binge drinking
- •23.has a history or current evidence of any condition that makes
- •participation not in the subject's best interest
- •24.has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products w
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