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Completed

NCT Number: NCT00819091

Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.35.54003 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

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug

Exclusion criteria

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance

Treatment and study plan

BI 1356

Drug

5mg orally (po) tablet qd

Placebo

Drug

Placebo matching BI 1356 5mg one tablet daily

Primary outcomes

  1. Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18

    Time frame: Baseline, week 18

    HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose at Week 18

    Time frame: Baseline, week 18

    Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.

  2. Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18

    Time frame: week 18

    An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.

  3. Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18

    Time frame: week 18

    An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.

  4. Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18

    Time frame: Baseline, week 18

    An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.

  5. Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6

    Time frame: Baseline, week 6

    HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  6. Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12

    Time frame: Baseline, week 12

    HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  7. Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18

    Time frame: Baseline, week 18

    HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  8. Change From Baseline in Fasting Plasma Glucose at Week 6

    Time frame: Baseline, week 6

    Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.

  9. Change From Baseline in Fasting Plasma Glucose at Week 12

    Time frame: Baseline, week 12

    Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.

Important dates

Study start
2008
Primary completion
2010
First posted
Jan 8, 2009
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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