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Completed

NCT Number: NCT00601250

Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.17.42001 Boehringer Ingelheim Investigational Site, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
  • Diagnosis of type 2 diabetes prior to informed consent
  • Glycosylated haemoglobin A1 (HbA1c)at screening:

For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

  • Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
  • Age 18 -80 years
  • BMI (Body Mass Index) less than 40 kg/m2
  • Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria

  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Impaired hepatic function
  • Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
  • Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
  • Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
  • Treatment with insulin within 3 months prior to informed consent
  • Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
  • Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
  • Participation in another trial with an investigational drug within 2 months prior to informed consent
  • Pre-menopausal 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 throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
  • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  • Renal failure or renal impairment
  • Unstable or acute congestive heart failure
  • Acute or chronic metabolic acidosis (present in patient history)
  • Hereditary galactose intolerance

Treatment and study plan

Linagliptin

Drug

Patients receive linagliptin 5 mg tablets once daily

Primary outcomes

  1. HbA1c Change From Baseline at Week 24

    Time frame: Baseline and week 24

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Secondary outcomes

  1. HbA1c Change From Baseline at Week 6

    Time frame: Baseline and week 6

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  2. HbA1c Change From Baseline at Week 12

    Time frame: Baseline and week 12

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  3. HbA1c Change From Baseline at Week 18

    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 baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  4. FPG Change From Baseline at Week 24

    Time frame: Baseline and week 24

    This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  5. FPG Change From Baseline at Week 6

    Time frame: Baseline and week 6

    This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  6. FPG Change From Baseline at Week 12

    Time frame: Baseline and week 12

    This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  7. FPG Change From Baseline at Week 18

    Time frame: Baseline and week 18

    This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  8. Percentage of Patients With HbA1c <7.0% at Week 24.

    Time frame: Baseline and week 24

    The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%

  9. Percentage of Patients With HbA1c < 7.0% at Week 24

    Time frame: Baseline and week 24

    The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.

  10. Percentage of Patients With HbA1c <6.5% at Week 24

    Time frame: Baseline and week 24

    The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%

  11. Percentage of Patients With HbA1c<6.5% at Week 24

    Time frame: Baseline and week 24

    The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.

  12. Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24

    Time frame: Baseline and week 24

    The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.

  13. Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24

    Time frame: Baseline and week 24

    This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.

  14. 2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline and week 24

    This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Important dates

Study start
2008
Primary completion
2009
First posted
Jan 28, 2008
Registry last updated
Jan 28, 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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