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

December 11, 2020 updated by: Novartis

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycosylated hemoglobin (HbA1c)at Baseline and week 24
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c at Baseline and week 12
Time Frame: 12 weeks
12 weeks
Fasting plasma glucose test (FPG) at Baseline and week 24
Time Frame: 24 weeks
24 weeks
Weight at baseline and week 24
Time Frame: 24 weeks
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
24 weeks
Safety assessed by monitoring and recording all adverse events, serious adverse events.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2007

Primary Completion (Actual)

June 6, 2008

Study Completion (Actual)

June 6, 2008

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

May 1, 2007

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLMF237A2302S1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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