EUCTR2008-002121-36-IT进行中（未招募）1 期
A Phase IIb/III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Dose-Range Finding Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin. - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 724
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
入选标准
- •Patient has type 2 diabetes mellitus (T2DM).
- •b. Patient is ≥21 and ≤70 years of age on day of signing informed consent.
- •c. Patient meets one of the following criteria as indicated by a yes answer to one of
- •the following:
- •Patient is currently on LANTUS insulin at a stable dose of ≥15 units/day, either
- •alone or in combination with metformin monotherapy at a dose of ≥1500 mg/day, for
- •at least 6 weeks and has a Visit 1/Screening Visit HbA1c ≥7.5% and ≤11.0%
- •Patient is in 1 of the following 4 categories and based upon review of the patient?s
- •current diet, medical regimen, and Visit 1/Screening Visit HbA1c, patient is
- •considered by the investigator as likely to meet Visit 4/Week -2 inclusion criterion of
- •HbA1c ≥7.5% and ≤11.0% after a 6-week dose stable period on LANTUS (at a dose
- •of ≥15 units/day):
- •1) Patient is currently on any injectable insulin(s) (other than LANTUS alone) at a
- •stable dose of ≥15 units/day, either alone OR in combination with metformin
- •monotherapy at a dose of ≥1500 mg/day, for at least 6 weeks and has a
- •Visit 1/Screening Visit HbA1c ≥7.5% and ≤11.0%
- •2) Patient is currently on any injectable insulin(s) at a stable dose of ≥15 units/day in
- •combination with metformin monotherapy at a dose of <1500 mg/day OR another
- •oral monotherapy agent at any dose except a TZD (e.g., pioglitazone or
- •rosiglitazone), for at least 6 weeks and has a Visit 1/Screening Visit HbA1c
- •≥7.0% and ≤10.5%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- •Patient is assessed by the investigator as possibly having type 1 diabetes confirmed
- •with a C-peptide <0.7 ng/mL (<0.23 nmol/L).
- •Note: Only patients assessed by the investigator as possibly having type 1 diabetes
- •should have C-peptide measured at Visit 1/Screening Visit.
- •b. Patient received more than 1 week of dosing of TZD therapy (e.g., pioglitazone or
- •rosiglitazone) or injectable incretin-based therapy (e.g., Byetta) within the prior 8
- •c. Patient has had two or more episodes during their lifetime or more than one episode
- •within the past year that resulted in hypoglycemic seizures, comas or
- •unconsciousness.
- •Patients Requiring Specific Treatments
- •d. Hypersensitivity or contraindication to LANTUS insulin.
- •Patient is on a weight loss program and is not in the maintenance phase, or patient is
- •taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within
- •8 weeks of Visit 1/Screening Visit.
- •f. Patient has received treatment with an investigational drug within the prior 3 months
- •or is currently participating or planning to participate in another clinical trial.
- •g. Patient is on or likely to require treatment with warfarin or warfarin-like
- •anticoagulants, digoxin, or any other medication with a narrow therapeutic index
- •(refer to Appendix 6.4).
- •h. Patient is on or likely to require treatment with immunosuppressive/
- •immunomodulating agents (e.g., cyclosporine, methotrexate, etanercept) or patient is
- •on or likely to require treatment of ≥14 consecutive days or repeated courses of
- •pharmacologic doses of systemic (oral, injectable/parenteral) or ocular
- •corticosteroids, during the study.
研究者
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