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Completed

NCT Number: NCT00716092

The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate 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 2

Primary location

1218.37.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany

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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 not more than one drug
  • Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Exclusion criteria

  • Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
  • Impaired hepatic function
  • Renal insufficiency with a creatinine clearance < 50 mL/min
  • Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.

Treatment and study plan

Placebo (linagliptin)

Drug

once daily for 28 days

Sitagliptin

Drug

100 mg once daily for 28 days

Placebo (sitagliptin)

Drug

once daily for 28 days

Linagliptin

Drug

5mg once daily for 28 days

Primary outcomes

  1. Weighted Mean Glucose (WMG) Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.

  2. GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.

Secondary outcomes

  1. Fasting Plasma Glucose (FPG) Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.

  2. Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).

Other outcomes

  1. Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.

  2. Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.

  3. Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.

  4. Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28

    Time frame: Baseline and day 28

    The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients

Important dates

Study start
2008
Primary completion
2008
First posted
Jul 16, 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.

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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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