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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716092
• Other study ID #: 1218.37
• Secondary ID: 2007-007865-19
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2008
• Last updated: June 18, 2014
• Start date: July 2008

Study information

• Verified date: January 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo (linagliptin)
once daily for 28 days
• Placebo (linagliptin)
once daily for 28 days
• Sitagliptin
100 mg once daily for 28 days
• Placebo (sitagliptin)
once daily for 28 days
• Placebo (sitagliptin)
once daily for 28 days
• Linagliptin
5mg once daily for 28 days

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Sensitivity Analysis of the WMG Change From Baseline at 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.	Baseline and day 28	No
Other	Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at 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.	Baseline and day 28	No
Other	Exploratory Sensitivity Analysis of FPG Change From Baseline at 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.	Baseline and day 28	No
Other	Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at 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.	Baseline and day 28	No
Primary	Weighted Mean Glucose (WMG) Change From Baseline at 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.	Baseline and day 28	No
Primary	GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at 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.	Baseline and day 28	No
Secondary	Fasting Plasma Glucose (FPG) Change From Baseline at 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.	Baseline and day 28	No
Secondary	Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at 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).	Baseline and day 28	No

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