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Completed

NCT Number: NCT01087502

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glimepiride

Drug

1-4 mg daily after 12 weeks

Placebo

Drug

Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily

Linagliptin

Drug

5 mg once daily

Primary outcomes

  1. HbA1c Change From Baseline to Week 12

    Time frame: Baseline and week 12

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.

Secondary outcomes

  1. HbA1c Change From Baseline Over Time

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.

  2. Fasting Plasma Glucose (FPG) Change From Baseline to Week 12

    Time frame: Baseline and week 12

    This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.

  3. Fasting Plasma Glucose (FPG) Change From Baseline Over Time

    Time frame: Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52

    This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.

  4. Percentage of Patients With HbA1c <7.0%

    Time frame: Baseline, week 12 and week 52

    The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.

  5. Percentage of Patients With HbA1c <6.5%

    Time frame: Baseline, week 12 and week 52

    The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.

  6. Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%

    Time frame: Baseline, week 12 and week 52

    The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.

  7. Plasma Concentration of Linagliptin at Trough

    Time frame: Week 12, 24 and 52

    Trough levels of concentration of Linagliptin in plasma.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
First posted
Mar 16, 2010
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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