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OpenTrials
Completed

NCT Number: NCT00996658

Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

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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–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.61.3301A Boehringer Ingelheim Investigational Site, Besançon, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of diabetes mellitus prior to informed consent
  • Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
  • Glycosylated haemoglobin A1 >= 7.5% and <= 10%
  • Age between 18 and less than 80
  • - Body Mass index less or equal to 45

Exclusion criteria

  • Uncontrolled hyperglycaemia during run in period
  • Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
  • Impaired hepatic function
  • Gastric by pass surgery
  • Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
  • Treatment with anti-obesity drugs
  • Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  • Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial

Treatment and study plan

Placebo

Drug

Placebo matching linagliptin tablets once daily

Linagliptin

Drug

Linagliptin tablets once daily

Primary outcomes

  1. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks

    Time frame: baseline, 24 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

Secondary outcomes

  1. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks

    Time frame: baseline, 6 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  2. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks

    Time frame: baseline, 12 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  3. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks

    Time frame: baseline, 18 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  4. Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks

    Time frame: 24 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  5. Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks

    Time frame: 24 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  6. Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks

    Time frame: 24 weeks

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  7. Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks

    Time frame: baseline, 24 weeks

    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24

  8. Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks

    Time frame: baseline, 6 weeks

    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6

  9. Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks

    Time frame: baseline, 12 weeks

    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12

  10. Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks

    Time frame: baseline, 18 weeks

    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18

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 Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone

Important dates

Study start
2009
Primary completion
2012
First posted
Oct 16, 2009
Registry last updated
Mar 26, 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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