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Completed

NCT Number: NCT00654381

Japanese P III vs Voglibose and Placebo

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

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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

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.23.05 Boehringer Ingelheim Investigational Site, Asahi, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
  • Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
  • Age: >= 20 and <= 80
  • Body Mass Index (BMI) <= 40 kg/m2

Exclusion criteria

  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
  • Impaired hepatic function
  • History of severe allergy/hypersensitivity
  • Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
  • Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

Treatment and study plan

BI 1356

Drug

5 mg/daily

voglibose placebo

Drug

three times daily

BI 1356 placebo

Drug

once daily

Voglibose

Drug

0.6 mg/daily

Primary outcomes

  1. Change From Baseline in HbA1c at Week 12

    Time frame: 12 weeks

    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  2. Change From Baseline in HbA1c at Week 26

    Time frame: 26 weeks

    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  3. Examination of Long-term Safety of Linagliptin (52-week Treatment)

    Time frame: 52 weeks

    The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks

Secondary outcomes

  1. Relative Efficacy Response of HbA1c at Week 12

    Time frame: 12 weeks

    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12

  2. Relative Efficacy Response of HbA1c at Week 26

    Time frame: 26 weeks

    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26

  3. Relative Efficacy Response of HbA1c at Week 52

    Time frame: 52 weeks

    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

    Time frame: 12 weeks

    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  5. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

    Time frame: 26 weeks

    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  6. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

    Time frame: 52 weeks

    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety

Important dates

Study start
2008
Primary completion
2010
First posted
Apr 8, 2008
Registry last updated
Jan 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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