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Completed

NCT Number: NCT00740051

A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.50.11001 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

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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 (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria

Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance

Treatment and study plan

Linagliptin

Drug

5mg once daily

linagliptin placebo

Drug

0 mg placebo comparator for part 1 of study (to 18 weeks)

Glimepiride

Drug

1-4mg for part 2 of study (weeks 19-52)

Primary outcomes

  1. HbA1c Change From Baseline at Week 18 (Interim Analysis)

    Time frame: Baseline and week 18

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

  2. HbA1c Change From Baseline at Week 18 (Final Analysis)

    Time frame: Baseline and week 18

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.

Secondary outcomes

  1. Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)

    Time frame: Baseline and week 18

    This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).

  2. Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)

    Time frame: Week 18

    Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

  3. Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)

    Time frame: Week 18

    Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

  4. Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)

    Time frame: Week 18

    Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

  5. The Change in HbA1c From Baseline by Visit Over Time

    Time frame: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.

  6. The Change in FPG From Baseline by Visit Over Time

    Time frame: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52

    This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 22, 2008
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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