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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Placebo (linagliptin)
* Drug: Placebo (linagliptin)
* Drug: Sitagliptin
* Drug: Placebo (sitagliptin)
* Drug: Placebo (sitagliptin)
* Drug: Linagliptin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin. | Drug: Placebo (linagliptin)<br>* once daily for 28 days<br>Drug: Placebo (sitagliptin)<br>* once daily for 28 days<br>|
| Experimental: Linagliptin<br>Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin. | Drug: Placebo (sitagliptin)<br>* once daily for 28 days<br>Drug: Linagliptin<br>* 5mg once daily for 28 days<br>|
| Active Comparator: Sitagliptin<br>Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin. | Drug: Placebo (linagliptin)<br>* once daily for 28 days<br>Drug: Sitagliptin<br>* 100 mg once daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |