Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084005

1218.63

2009-015255-25 (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 given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control

Enrollment: 241 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 2 diabetes mellitus
2. HbA1c >= 7.0%
3. Age >= 70 years
4. Signed and dated written informed consent

Exclusion criteria

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
2. Impaired hepatic function
3. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins
4. Treatment with anti-obesity drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 2 patient groups, including a placebo group

linagliptin

Experimental group

Description:

patients receive linagliptin 5 mg tablets once daily

Treatment:

Drug: linagliptin

placebo

Placebo Comparator group

Description:

patients receive placebo tablets matching linagliptin 5 mg once daily

Treatment:

Drug: placebo