A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00468039

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin + metformin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control

Actual Study Start Date :

Mar 6, 2007

Actual Primary Completion Date :

Jun 6, 2008

Actual Study Completion Date :

Jun 6, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vildagliptin + metformin	Drug: vildagliptin + metformin

Arm

Intervention/Treatment

Experimental: vildagliptin + metformin

Drug: vildagliptin + metformin

Outcome Measures

Primary Outcome Measures

glycosylated hemoglobin (HbA1c)at Baseline and week 24 [24 weeks]

Secondary Outcome Measures

HbA1c at Baseline and week 12 [12 weeks]
Fasting plasma glucose test (FPG) at Baseline and week 24 [24 weeks]
Weight at baseline and week 24 [24 weeks]
Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks [24 weeks]
Safety assessed by monitoring and recording all adverse events, serious adverse events. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
Body mass index 22-40 kg/meter squared
HbA1c > 11% and/or FPG >270 mg/dL