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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138554
• Other study ID #: CLAF237A2304E1
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2005
• Last updated: February 21, 2017
• Start date: November 2004
• Est. completion date: July 2006

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

• Other protocol-defined exclusion criteria may apply

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• vildagliptin

• pioglitazone
pioglitazone 45 mg qd

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
Primary	Change from baseline in HbA1c at 52 weeks
Secondary	Change in HbA1c between 24 weeks and 52 weeks
Secondary	Change from baseline in fasting plasma glucose at 52 weeks
Secondary	Change in fasting plasma glucose between 24 weeks and 52 weeks
Secondary	Change from baseline in HOMA B at 52 weeks
Secondary	Change from baseline in HOMA IR at 52 weeks

External Links

•   Results for CLAF237A2304E1 from Novartis Clinical Trials Website