Type 2 diabetes pretreated with basal Insulin therapy MedDRA version: 9.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus, confirmed by a measurable C-peptide level at Visit 1 (screening) 2. Pre-treatment with basal insulin alone or basal insulin in combination with Metformin or/and Pioglitazone. Acceptable basal insulins could be insulin glargin, insulin detemir or NPH (neutral protamin hagedorn) insulin with duration of action up to 24 h. This antidiabetic therapy has to be unchanged for at least 12 weeks prior to Visit 3 (randomisation). 3. HbA1c =7.0 % and 18 years at Visit 1 5. BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled fasting hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after fast of at least 6 hours during placebo run-in, confirmed by a second measurement on a following day. 2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent. 3. Impaired hepatic function at Visit 1. 4. Gastric bypass surgery. 5. Medical history of cancer (except for basal cell carcinoma) with respective treatment in the last 5 years prior to screening. 6. Known hypersensitivity or allergy to the investigational product or its recipients. 7. Any contraindications to metformin according to the local label for those patients that enter the study with metformin therapy. 8. Any contraindications to Pioglitazone according to the local label for those patients that enter the study with pioglitazone therapy. 9. Treatment with rosiglitazone, sulfonylurea, GLP-1 analogues or DPP-IV inhibitors within 3 months prior to informed consent. 10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent. 11. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation. 12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 13. Participation in another trial with an investigational drug within 2 months prior to informed consent. 14. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.;Secondary Objective: Evaluation of efficacy, safety and tolerability of linagliptin in patients with mild to moderate renal impairment.;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment. | — |
Countries
Czech Republic, Finland, Germany, Italy, Netherlands, Slovakia, Spain, Sweden
Outcome results
None listed