Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.

Official Title
-----------------
An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Vildagliptin (LAF237)
* Drug: Voglibose
* Drug: Vildagliptin and Voglibose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP) Exclusion Criteria: Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1<br> | Drug: Vildagliptin (LAF237)<br> <br> Drug: Voglibose<br> <br> Drug: Vildagliptin and Voglibose<br> <br> |
| Experimental: Treatment Sequence 2<br> | Drug: Vildagliptin (LAF237)<br> <br> Drug: Voglibose<br> <br> Drug: Vildagliptin and Voglibose<br> <br> |
| Experimental: Treatment Sequence 3<br> | Drug: Vildagliptin (LAF237)<br> <br> Drug: Voglibose<br> <br> Drug: Vildagliptin and Voglibose<br> <br> |
| Experimental: Treatment Sequence 4<br> | Drug: Vildagliptin (LAF237)<br> <br> Drug: Voglibose<br> <br> Drug: Vildagliptin and Voglibose<br> <br> |
| Experimental: Treatment Sequence 5<br> | Drug: Vildagliptin (LAF237)<br> <br> Drug: Voglibose<br> <br> Drug: Vildagliptin and Voglibose<br> <br> |
| Experimental: Treatment Sequence 6<br> | Drug: Vildagliptin (LAF237)<br> <br> Drug: Voglibose<br> <br> Drug: Vildagliptin and Voglibose<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of vildagliptin |  | Up to 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon) |  | Up to 4 hours or 12 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug interaction