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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01087502
First received: March 15, 2010
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Glimepiride
Drug: Placebo
Drug: Linagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c lowering at least 0,5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c bt visit over time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in FPG by visit over time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of linagliptin [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Composite of HbA1c <7,0%, no weight gain and hypoglyaemia [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • HbA1c of <6,5% as well as < 7,5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: March 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linagliptin
52 weeks treatment
 Drug: Placebo
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Drug: Linagliptin
5 mg once daily
Placebo Comparator: Placebo
First 12 weeks of treatment
 Drug: Placebo
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Active Comparator: Glimepiride
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
 Drug: Glimepiride
1-4 mg daily after 12 weeks
Drug: Placebo
Placebo mach to 5 mg linagliptin once daily after 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087502

  Show 52 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01087502     History of Changes
Other Study ID Numbers: 1218.64, 2009-016971-31
Study First Received: March 15, 2010
Last Updated: October 17, 2012
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Health Canada
Finland: Finnish Medicines Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Japan: Ministry of Health, Labor and Welfare
New Zealand: Multi-Regional Ethics Committee
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
BI 1356
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013