EUCTR2008-008127-15-DE进行中（未招募）不适用
A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by a 54 week blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg or linagliptin 5 mg in type 2 diabetic patients with insufficient glycaemic control on diet and exercise
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
- 1,800
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
- •- Diagnosis of type 2 diabetes mellitus prior to informed consent
- •- Male and female patients with insufficient glycaemic control (HbA1c = 7.0 to =
- •10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy
- •within 10 weeks prior to start of the run-in period
- •- Age = 18 and = 80 years at start of screening
- •- BMI = 45 kg/m2 (Body Mass Index) at start of screening
- •- Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period
- •- Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
- •- Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
- •- Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
- •- Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
- •- Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)
- •- Contraindications to pioglitazone as defined in the local prescribing information
- •- Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin
- •- Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
- •- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
- •- Alcohol or drug abuse within the 3 months prior to informed consent or documented history of alcoholism
- •- Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- •- Participation in another trial with an investigational drug within 30 days prior to informed consent
- •- Pre-menopausal women (last menstruation < 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control
- •- Symptomatic gallbladder disease in the last six months
- •- Medical history of pancreatitis
研究者
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