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

NCT ID: NCT00138554

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-07-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vildagliptin 50 mg qd + pioglitazone 45 mg qd

vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks

Group Type: EXPERIMENTAL

vildagliptin

Intervention Type: DRUG

pioglitazone

Intervention Type: DRUG

pioglitazone 45 mg qd

vildagliptin 50 mg bd+ pioglitazone 45 mg qd

vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks

Group Type: EXPERIMENTAL

vildagliptin

Intervention Type: DRUG

pioglitazone

Intervention Type: DRUG

pioglitazone 45 mg qd

Interventions

vildagliptin

Intervention Type: DRUG

pioglitazone

pioglitazone 45 mg qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Premature discontinuation from study CLAF237A2304

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

References

Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab. 2010 Jun;12(6):495-509. doi: 10.1111/j.1463-1326.2010.01214.x.

Reference Type: RESULT

PMID: 20518805 (View on PubMed)

Other Identifiers

CLAF237A2304E1

Identifier Type: -

Identifier Source: org_study_id