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

Boehringer Ingelheim logo

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

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

Trial contacts and locations

52

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Data sourced from clinicaltrials.gov

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