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).

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

Conditions

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Further Details

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 ]

 

Arms  Assigned Interventions
 Linagliptin: Experimental

 52 weeks treatment
 5 mg once daily

 Drug: Linagliptin
 Placebo: Placebo Comparator 
 First 12 weeks of treatment
 once daily
 Drug: Placebo
 Glimepiride: Active Comparator
 Placebo patients switch to glimepiride

 after 12 weeks (40 weeks treatment)

 Drug: Glimepiride
 1-4 mg daily

Study Start

March 2010 – November 2011

Eligibility & Criteria

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


Inclusion Criteria:

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

 

Exclusion Criteria:

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

Total Enrolment

240

Contact Details

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

 

Australia, New South Wales

1218.64.61005 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia

1218.64.61001 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia

1218.64.61002 Boehringer Ingelheim Investigational Site, St Leonards, New South Wales, Australia

Australia, South Australia

1218.64.61003 Boehringer Ingelheim Investigational Site, Adelaide, South Australia, Australia

Australia, Victoria

1218.64.61004 Boehringer Ingelheim Investigational Site, Reservoir, Victoria, Australia