Type 2 Diabetes Mellitus MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Product Name: BI 1356
Product Code: BI 1356 BS
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: linagliptin
CAS Number: 668270-12-0
Current Sponsor code: BI 1356 BS
Concentration unit: mg
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients pre-treated with metformin and pioglitazone; antidiabetic therapy has to be unchanged for 12 weeks prior to informed consent. 3. Metformin therapy should be >= 1500 mg/day or on the maximum tolerated dose for 12 weeks prior to informed consent*. 4. Pioglitazone therapy should be 45 mg/day or the maximum clinically acceptable dose in the investigators opinion. The dose should be unchanged for 12 weeks prior to informed consent. 5. Glycosylated haemoglobin A1 (HbA1c) =7.5% and = 10 at Visit 1 (randomisation criterion) 4. Age >= 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast or > 400 mg/dl (22.2 mmol/l) in a randomly performed measurement during placebo run-in and confirmed by a second 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 1 4. Gastric bypass surgery 5. Known hypersensitivity or allergy to the investigational product or its excipients, to metformin or pioglitazone. 6. Metformin and/or pioglitazone are not used in accordance with the local prescribing information. 7. Treatment with rosiglitazone, GLP-1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent 8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent 9. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation as well as drug abuse 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 (other than oral antidiabetic treatments) within 2 months prior to informed consent 12. Pre-menopausal women (last menstruation <= 1 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, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • 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 ;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the last observation prior to the treatment phase.;Main Objective: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control. | — |
Countries
France
Outcome results
None listed