Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00099853

First received: December 21, 2004

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2004

Last Updated Date

January 2, 2013

Start Date ^ICMJE

May 2004

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c after 24 weeks

Original Primary Outcome Measures ^ICMJE

Blood glucose levels

Change History

Complete list of historical versions of study NCT00099853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Official Title ^ICMJE

Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is 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 either pioglitazone or rosiglitazone alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Vildagliptin
Vildagliptin 50 mg tablets
Other Names:
- LAF237
- Galvus
Drug: pioglitazone
pioglitazone 45 mg qd
Drug: Placebo
Vildagliptin matching placebo

Study Arm (s)

Experimental: Vildagliptin 50 mg qd + pioglitazone 45 mg qd
Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks
Interventions:
- Drug: Vildagliptin
- Drug: pioglitazone
Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd
Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks
Interventions:
- Drug: Vildagliptin
- Drug: pioglitazone
Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd
Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks
Interventions:
- Drug: pioglitazone
- Drug: Placebo

Publications *

Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

362

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Blood glucose criteria must be met
Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
Body mass index (BMI) in the range 22-45

Exclusion Criteria:

Type 1 diabetes
Pregnancy or lactation
Evidence of serious cardiovascular complications
Evidence of serious diabetic complications
Laboratory value abnormalities as defined by the protocol
Known sensitivity to pioglitazone
Other protocol-defined exclusion criteria may apply

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00099853

Other Study ID Numbers ^ICMJE

CLAF237A2304

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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