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Completed

NCT Number: NCT00954447

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.36.54001 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetes type 2, detectable C-peptide, HbA1c 7-10%
  • Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria

  • Uncontrolled hyperglycemia during Run-in
  • Myocardial infarction, stroke or TIA within 3 months prior to informed consent
  • Liver impairment; gastric surgery; medical history of cancer in last 5 years
  • Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
  • Unsufficient birth control, pregnancy and nursing

Treatment and study plan

Placebo

Drug

Placebo, identical to Linagliptin tablet

Linagliptin

Drug

intended final marketed dose

Primary outcomes

  1. Change From Baseline in HbA1c After 24 Weeks

    Time frame: Baseline and 24 weeks

    HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)

Secondary outcomes

  1. Number of Patients With HbA1c < 7.0 Percent

    Time frame: 24 and 52 weeks

  2. Number of Patients Lowering HbA1c by at Least 0.5 Percent

    Time frame: 24 and 52 weeks

  3. Change From Baseline in HbA1c by Visit at Week 6

    Time frame: Baseline and 6 weeks

    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  4. Change From Baseline in HbA1c by Visit at Week 12

    Time frame: Baseline and 12 weeks

    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  5. Change From Baseline in HbA1c by Visit at Week 18

    Time frame: Baseline and 18 weeks

    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  6. Change From Baseline in HbA1c by Visit at Week 32

    Time frame: Baseline and 32 weeks

    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  7. Change From Baseline in HbA1c by Visit at Week 40

    Time frame: Baseline and 40 weeks

    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  8. Change From Baseline in HbA1c by Visit at Week 52

    Time frame: Baseline and 52 weeks

    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  9. Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment

    Time frame: Baseline and 24 weeks

    Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs

  10. Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

    Time frame: Baseline and 52 weeks

  11. Change From Baseline in FPG

    Time frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks

  12. Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment

    Time frame: Baseline and 52 weeks

    Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs

  13. Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment

    Time frame: Baseline, 24 and 52 weeks

    Mean Daily Glucose was calculated using the 8-point blood glucose profile

  14. Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment

    Time frame: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner

Other outcomes

  1. Number of Patients With HbA1c < 6.5 Percent

    Time frame: 24 and 52 weeks

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 for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy

Important dates

Study start
2009
Primary completion
2011
First posted
Aug 7, 2009
Registry last updated
Dec 30, 2013

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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