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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Vildagliptin

pioglitazone

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes, vildagliptin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin 50 mg qd + pioglitazone 45 mg qd

Vildagliptin 50 mg bid + pioglitazone 45 mg qd

Vildagliptin placebo + pioglitazone 45 mg qd

Arm Description

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

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

Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00099853

First Posted

December 21, 2004

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00099853

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes, vildagliptin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

362 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin 50 mg qd + pioglitazone 45 mg qd

Arm Type

Experimental

Arm Description

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

Arm Title

Vildagliptin 50 mg bid + pioglitazone 45 mg qd

Arm Type

Experimental

Arm Description

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

Arm Title

Vildagliptin placebo + pioglitazone 45 mg qd

Arm Type

Placebo Comparator

Arm Description

Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Other Intervention Name(s)

LAF237, Galvus

Intervention Description

Vildagliptin 50 mg tablets

Intervention Type

Drug

Intervention Name(s)

pioglitazone

Intervention Description

pioglitazone 45 mg qd

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Vildagliptin matching placebo

Primary Outcome Measure Information:

Title

Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in fasting plasma glucose at 24 weeks

Title

Patients with endpoint HbA1c <7% after 24 weeks

Title

Patients with reduction in HbA1c >/= to 0.7% after 24 weeks

Title

Adverse event profile after 24 weeks of treatment

Title

Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Pharmaceuticals

City

East Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17300592

Citation

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.

Results Reference

derived

Links:

URL

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

Description

Results for CLAF237A2304 from the Novartis Clinical Trials website

Learn more about this trial

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

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