NCT01408095撤回2 期
A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2608204 Given as Monotherapy or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c)
研究概览
简要总结
The study is designed to see if once daily oral dosing of LY2608204 will help control diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also help to determine the safety of the medication and the most useful doses of the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
- •May be treated with:
- •Diet and exercise alone or
- •Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
- •Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
- •Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
- •Must have an Hemoglobin A1c value between 7% and 10%
- •Must have a body mass index (BMI) between 20 and 40 kg/m2
- •Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
- •If female, you must not be able to get pregnant
- •Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
排除标准
- •Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
- •Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
- •Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
- •Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
- •Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
- •Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
- •Have a QTcB (Bazett's-corrected QT interval) interval greater than 450 msec for men or greater than 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
- •Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
- •Are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dL (177 μmol/L) or a calculated creatinine clearance of less than 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
- •Have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
- •Are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
- •Have an active or untreated malignancy or have been in remission from a clinically significant 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 a history of seizure disorder
- •Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
- •Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
研究组 & 干预措施
LY2608204
Experimental
80 to 400 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. The starting dose level depends on the participant's HbA1c level measured at Screening. Administered orally, daily for 12 weeks
干预措施: LY2608204 (Drug)
Glimepiride
Active Comparator
1 to 6 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. Administered orally, daily for 12 weeks
干预措施: Glimepiride (Drug)
结局指标
主要结局
Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c)
时间窗: Baseline, 12 Weeks
次要结局
- Change from baseline to 12 week endpoint in fasting blood glucose(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint in average Seven Point Self Monitored Blood Glucose(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint for Oral Glucose Tolerance Test (OGTT)(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint in Homa-B: Insulin(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint in Homa-IR: Insulin(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint in Homa-S: Insulin(Baseline, 12 weeks)
- Change from baseline to 12 week endpoint in fasting lipids(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint in free fatty acids(Baseline, 12 Weeks)
- Change from baseline to 12 week endpoint in body weight(Baseline, 12 Weeks)
- Incidence of Hypoglycemic Episodes(Baseline through 12 weeks)
- Percentage of participants at each dose level up to 12 weeks(Baseline up to 12 weeks)
- Pharmacokinetics: Maximum plasma concentration (Cmax) of LY2608204(pre-dose, up to 12 hours post-dose)
- Number of participants with severe hypoglycemic episodes(Baseline through 12 weeks)
- Rate of hypoglycemic episodes(Baseline through 12 weeks)
- Pharmacokinetics: Area under the curve of concentration-time curve for one dosing interval at steady state (AUC0-tau, ss) of LY2608204(pre-dose, up to 12 hours post-dose)
研究者
研究点 (1)
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