Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin; Drug: Placebo; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01087502

2009-016971-31 (EudraCT Number)

1218.64

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 over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 2 diabetes mellitus
2. GFR<60 ml/min
3. HbA1c >=7.0% to <= 10%
4. Age >= 18 years
5. BMI <=45 kg/m2
6. Signed and dated written informed consent

Exclusion criteria

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
2. Renal impairment requiring dialysis
3. Bariatric surgery
4. Impaired hepatic function
5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
6. Treatment with anti-obesity drugs
7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 3 patient groups, including a placebo group

Linagliptin

Experimental group

Description:

52 weeks treatment

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Linagliptin

Placebo

Placebo Comparator group

Description:

First 12 weeks of treatment

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Glimepiride

Active Comparator group

Description:

Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Glimepiride