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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00716092
First received: July 15, 2008
Last updated: June 18, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo (linagliptin)
Drug: Sitagliptin
Drug: Placebo (sitagliptin)
Drug: Linagliptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Weighted Mean Glucose (WMG) Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Fasting Plasma Glucose (FPG) Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.

  • Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.

  • Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.

  • Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.

  • Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.


Enrollment: 121
Study Start Date: July 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.
Drug: Placebo (linagliptin)
once daily for 28 days
Drug: Placebo (sitagliptin)
once daily for 28 days
Experimental: Linagliptin
Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin.
Drug: Placebo (sitagliptin)
once daily for 28 days
Drug: Linagliptin
5mg once daily for 28 days
Active Comparator: Sitagliptin
Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.
Drug: Placebo (linagliptin)
once daily for 28 days
Drug: Sitagliptin
100 mg once daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716092

Locations
Germany
1218.37.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1218.37.49002 Boehringer Ingelheim Investigational Site
Mainz, Germany
1218.37.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00716092     History of Changes
Other Study ID Numbers: 1218.37, 2007-007865-19
Study First Received: July 15, 2008
Results First Received: May 13, 2011
Last Updated: June 18, 2014
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014