CTRI/2009/091/000105已完成2 期
Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 168
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
入选标准
- •Diabetes mellitus, type 2
- •-Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
- •-Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
- •-Have a qualifying HbA1c value, as determined by the central laboratory: at screening (for diet and exercise only = greater than or equal to 7.0% to less than or equal to 9.5%; for metformin monotherapy = >6.0% to less than or equal to 8.5%) and at time of randomization for all patients = greater than or equal to 7.0% to less than or equal to 9.5%
- •-Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
- •-Have a body mass index (BMI) between 23 and 40 kg/m2, inclusive, for patients who are native to, and reside in, South and/or East Asia; all other patients must have a BMI between 25 and 40 kg/m2, inclusive.
- •-Stable weight for 3 months prior to screening
排除标准
- •-Diabetes mellitus, type 1
- •-Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
- •-Use of GLP-1 analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
- •-Use of medications (prescription or over-the counter) to promote weight loss
- •-Chronic (>2 weeks) use of systemic glucocorticoid therapy
- •-Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
- •-Use of CNS stimulant (for example, Ritalin-SR)
- •-Cardiovascular event within 6 months prior to screening
- •-Poorly controlled hypertension (determined by a mean seated systolic BP greater than or equal to 160 mm Hg or mean seated diastolic BP greater than or equal to 95 mm Hg at screening or randomization)
- •-ECG reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
- •-Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal
- •-Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
- •-Amylase greater than or equal to 3 times the upper limit of normal and/or lipase greater than or equal to 2 times upper limit of normal which are determined by central labs at the time of screening
- •-Serum creatinine greater than or equal to 1.5 mg/dL for men or greater than or equal to 1.4 mg/dL for women or a creatinine clearance <60 mL/minute which are determined by central labs at the time of screening
- •-Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
- •-Significant active, uncontrolled endocrine or autoimmune abnormality
- •-History of a transplanted organ (corneal transplants are allowed)
- •-Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- •-Have any other condition, in the opinion of the investigator, that may preclude the patient from following or completing the protocol
- •-Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
- •-Sponsor employees
- •-Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •-Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
- •-Have previously completed or withdrawn from this study after providing informed consent
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