Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: vildagliptin; Drug: pioglitazone

• Registration Number: NCT00138554
• Lead Sponsor: Novartis

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-08-27
• Study First Submitted QC: 2005-08-27
• Study First Posted: 2005-08-30
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

• Only patients successfully completing study CLAF237A2304 are eligible
• Written informed consent
• Ability to comply with all study requirements

Read More

Exclusion Criteria

• Premature discontinuation from study CLAF237A2304
• Other protocol-defined exclusion criteria may apply

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vildagliptin 50 mg bd+ pioglitazone 45 mg qd	vildagliptin	vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks
vildagliptin 50 mg qd + pioglitazone 45 mg qd	vildagliptin	vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks
vildagliptin 50 mg qd + pioglitazone 45 mg qd	pioglitazone	vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks
vildagliptin 50 mg bd+ pioglitazone 45 mg qd	pioglitazone	vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks

Primary Outcome Measures

Name	Time	Method
Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c between 24 weeks and 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Change in fasting plasma glucose between 24 weeks and 52 weeks
Change from baseline in HOMA B at 52 weeks
Change from baseline in HOMA IR at 52 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States