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

NCT ID: NCT00099853

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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type 2 diabetes vildagliptin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vildagliptin 50 mg qd + pioglitazone 45 mg qd

Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin 50 mg tablets

pioglitazone

Intervention Type DRUG

pioglitazone 45 mg qd

Vildagliptin 50 mg bid + pioglitazone 45 mg qd

Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin 50 mg tablets

pioglitazone

Intervention Type DRUG

pioglitazone 45 mg qd

Vildagliptin placebo + pioglitazone 45 mg qd

Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks

Group Type PLACEBO_COMPARATOR

pioglitazone

Intervention Type DRUG

pioglitazone 45 mg qd

Placebo

Intervention Type DRUG

Vildagliptin matching placebo

Interventions

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Vildagliptin

Vildagliptin 50 mg tablets

Intervention Type DRUG

pioglitazone

pioglitazone 45 mg qd

Intervention Type DRUG

Placebo

Vildagliptin matching placebo

Intervention Type DRUG

Other Intervention Names

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LAF237 Galvus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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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. doi: 10.1111/j.1463-1326.2006.00684.x.

Reference Type DERIVED
PMID: 17300592 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2286

Results for CLAF237A2304 from the Novartis Clinical Trials website

Other Identifiers

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CLAF237A2304

Identifier Type: -

Identifier Source: org_study_id