Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00954447

1218.36

2008-008296-33 (EudraCT Number)

Details and patient eligibility

About

The objective of the current study is to investigate the 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.

Enrollment: 1,263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%
2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria

1. Uncontrolled hyperglycemia during Run-in
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
5. Unsufficient birth control, pregnancy and nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,263 participants in 2 patient groups, including a placebo group

Linagliptin

Experimental group

Description:

patient receives a tablet with intended final marketed dose

Treatment:

Drug: Linagliptin

Placebo

Placebo Comparator group

Description:

patient receives a tablet identical to those containing Linagliptin

Treatment:

Drug: Placebo