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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00099853

Collaborator

(none)

362

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: pioglitazone Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

362 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin 50 mg qd + pioglitazone 45 mg qd Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks	Drug: Vildagliptin Vildagliptin 50 mg tablets Other Names: LAF237 Galvus Drug: pioglitazone pioglitazone 45 mg qd
Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks	Drug: Vildagliptin Vildagliptin 50 mg tablets Other Names: LAF237 Galvus Drug: pioglitazone pioglitazone 45 mg qd
Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks	Drug: pioglitazone pioglitazone 45 mg qd Drug: Placebo Vildagliptin matching placebo

Arm

Intervention/Treatment

Experimental: Vildagliptin 50 mg qd + pioglitazone 45 mg qd

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

Drug: Vildagliptin

Vildagliptin 50 mg tablets

Other Names:

LAF237

Galvus

Drug: pioglitazone

pioglitazone 45 mg qd

Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd

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

Drug: Vildagliptin

Vildagliptin 50 mg tablets

Other Names:

LAF237

Galvus

Drug: pioglitazone

pioglitazone 45 mg qd

Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd

Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks

Drug: pioglitazone

pioglitazone 45 mg qd

Drug: Placebo

Vildagliptin matching placebo

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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