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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose

• Registration Number: NCT01309698
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Primary Completion: 2011-04
• Status Verified: 2016-11
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 6	Vildagliptin (LAF237)	-
Treatment Sequence 2	Vildagliptin and Voglibose	-
Treatment Sequence 4	Vildagliptin and Voglibose	-
Treatment Sequence 5	Vildagliptin and Voglibose	-
Treatment Sequence 6	Vildagliptin and Voglibose	-
Treatment Sequence 4	Vildagliptin (LAF237)	-
Treatment Sequence 5	Vildagliptin (LAF237)	-
Treatment Sequence 1	Vildagliptin and Voglibose	-
Treatment Sequence 3	Vildagliptin (LAF237)	-
Treatment Sequence 3	Vildagliptin and Voglibose	-
Treatment Sequence 1	Vildagliptin (LAF237)	-
Treatment Sequence 2	Vildagliptin (LAF237)	-
Treatment Sequence 5	Voglibose	-
Treatment Sequence 4	Voglibose	-
Treatment Sequence 3	Voglibose	-
Treatment Sequence 1	Voglibose	-
Treatment Sequence 2	Voglibose	-
Treatment Sequence 6	Voglibose	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of vildagliptin	Up to 12 hours post-dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Tokyo, Japan