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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01309698

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Sequence 1	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 2	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 3	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 4	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 5	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 6	Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of vildagliptin [Up to 12 hours post-dose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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