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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00468039

Enrollment

Registered

2007-05-01

Start date

2007-03-06

Completion date

2008-06-06

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

metformin, vildagliptin, initial combination

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.

Interventions

DRUGvildagliptin + metformin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

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

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/

Design outcomes

Primary

Measure	Time frame
glycosylated hemoglobin (HbA1c)at Baseline and week 24	24 weeks

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026