A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin therapy

• Conditions: Type 2 diabetes pretreated with basal Insulin therapy; MedDRA version: 9.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent; MedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitus

• Registration Number: EUCTR2008-008296-33-DE
• Lead Sponsor: Boehringer-Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-20
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

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 =10.0 % at Visit 1
4. Age = 18 years at Visit 1
5. BMI = 45 kg/m2 (Body Mass Index) at Visit 1
6. Signed and dated written informed consent by date of Visit 1
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.