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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Vildagliptin and Voglibose; Drug: Vildagliptin (LAF237); Drug: Voglibose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309698

CLAF237A1103

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Treatment Sequence 1

Experimental group

Treatment:

Drug: Voglibose

Drug: Vildagliptin and Voglibose

Drug: Vildagliptin (LAF237)

Treatment Sequence 2

Experimental group

Treatment:

Drug: Voglibose

Drug: Vildagliptin and Voglibose

Drug: Vildagliptin (LAF237)

Treatment Sequence 3

Experimental group

Treatment:

Drug: Voglibose

Drug: Vildagliptin and Voglibose

Drug: Vildagliptin (LAF237)

Treatment Sequence 4

Experimental group

Treatment:

Drug: Voglibose

Drug: Vildagliptin and Voglibose

Drug: Vildagliptin (LAF237)

Treatment Sequence 5

Experimental group

Treatment:

Drug: Voglibose

Drug: Vildagliptin and Voglibose

Drug: Vildagliptin (LAF237)

Treatment Sequence 6

Experimental group

Treatment:

Drug: Voglibose

Drug: Vildagliptin and Voglibose

Drug: Vildagliptin (LAF237)