CTRI/2009/091/001081已完成3 期
A phase III, randomized, double blind, placebo-controlled parallel group efficacy and safety study of Linagliptin 5 mg administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with pioglitazone
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 10
- 主要终点
- Change from baseline in HbA1c value
研究概览
简要总结
Short description of the primary purpose of the protocol, including a brief statement of the study hypothesis. This study is a randomized, double blind, parallel group, multi-centre trail comparing the safety and efficacy of Linagliptin 5 mg daily for 6 months in 290 patients with diabetes that will be conducted in seven centers in India and sixty three in USA, France and Philippines. The primary outcome measures will be the change from baseline in HbA1c values after 24 weeks of treatment. The secondary outcomes will be occurrence of a treat to target response that is an HbA1c under treatment of < 7.0 % after 24 weeks of treatment. Occurrence of a treat to target response that is an HbA1c under treatment of < 6.5 % after 24 weeks of treatment. Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5 % after 24 weeks of treatment). HbA1c reduction from baseline by visit over time. Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Change from baseline in FPG by visit over time.
Expected date of First Enrollment in India - 4th February 2010
The final (actual) enrollment from India - 140 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Diagnosis of type 2 Diabetes Mellitus prior to Informed consent
- •Male and female patients pretreated with metformin and pioglitazone;antidiabetic therapy has to be unchanged for 12 weeks prior to Informed consent
- •Metformin therapy should be greater than or equal to1500 mg/day or on the maximum tolerated dose for 12 weeks prior to Informed consent
- •Pioglitazone therapy should be 45 mg/day or the maximum clinically acceptable dose in investigators opinion.
- •The dose should be unchanged for 12 weeks prior to Informed consent
- •Glycosylated haemoglobin A1 (HbA1c) greater than or equal to 7.5% and less than or equal to10% at visit 1 (randomization criterion)
- •Age greater than or equal to 18 and less than or equal to 80 years at Visit 1 (Screening)
- •Signed and dated written Informed consent by date of visit 1 in accordance with GCP and local legislation.
- •Note: patients currently treated with a total daily dose of metformin of less than 1500 mg can be included in the trial if investigator has documented that the dose is maximum tolerated dose of metformin for that patient.
排除标准
- •1.Uncontrolled hyperglycemia with a glucose level greater than 240 mg/dl (greater than13.3mmol/L) after an overnight fasting or greater than 400 mg/dl (greater than 22.2 mmol/L)in a randomly performed measurement during placebo run in and confirmed by secondary measurement (not on the same day).
- •2.Myocardial infarction, stroke or TIA within 3 months prior to informed consent.
- •3.Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit
- •4.Gastric Bypass surgery.
- •5.Known hypersensitivity or allergy to the investigational product or its excipients, metformin or pioglitazone.
- •6.Metformin and/or pioglitazone are not used in accordance with prescribing information.
- •7.Treatment with rosiglitazone, GLP-1 analogues, DPP-4 inhibitor or insulin within 3 months prior to informed consent 8.Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent 9.Alcohol or drug abuse within the 3 months prior to informed consent that in the investigators opinion would interfere with trial participation 10.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent 11.Participation in another trial with an investigational drug within 2 months prior to informed consent 12.Pre-menopausal women (last menstruation less than or equal toƒn1 year prior to informed consent) who: -are nursing or pregnant or -are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
- •Acceptable methods of birth control include transdermal patch, intrauterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomized partner.
结局指标
主要结局
Change from baseline in HbA1c value
时间窗: 24 weeks of treatment
次要结局
- Occurrence of a treat to target response that is an HbA1c under treatment of less than 7.0 %(24 weeks of treatment.)
- Occurrence of a treat to target response that is an HbA1c under treatment of < 6.5 %(24 weeks of treatment.)
- Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5 %)(24 weeks of treatment.)
- HbA1c reduction from baseline(Visit over time)
- Change from baseline in fasting plasma glucose (FPG)(24 weeks of treatment.)
- Change from baseline in FPG(Visit over time)
研究者
研究点 (10)
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