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 blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg or linagliptin 5 mg for up to 54 weeks in type 2 diabetic patients with insufficient glycaemic control on diet and exercise
- Conditions
- type 2 diabetes mellitusMedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2008-008127-15-GB
- Lead Sponsor
- Boehringer Ingelheim Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1800
- 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
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
- 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
- Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
- Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method