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

Novartis94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptin + metforminDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Pregnant or lactating female * History of type 1 diabetes * Evidence of significant diabetic complications * Treatment with insulin or any other oral antidiabetic agent Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Diabetes and Glandular Disease Research Associates

San Antonio, Texas, United States

Outcomes

Primary Outcomes

glycosylated hemoglobin (HbA1c)at Baseline and week 24

Time frame: 24 weeks

Secondary Outcomes

HbA1c at Baseline and week 12

Time frame: 12 weeks

Fasting plasma glucose test (FPG) at Baseline and week 24

Time frame: 24 weeks

Weight at baseline and week 24

Time frame: 24 weeks

Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks

Time frame: 24 weeks

Safety assessed by monitoring and recording all adverse events, serious adverse events.

Time frame: 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.