Completed

Vildagliptin vs Metformin: Safety and Effectiveness in Drug-Naive Type 2 Diabetes

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Study Aim

This study aims to compare the safety and effectiveness of Vildagliptin versus Metformin in treating type 2 diabetes in individuals who have not previously taken medication, by observing changes in HbA1c levels over 52 weeks.

What is being tested

vildagliptin

+ Metformin Comparator

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Official TitleEfficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
NCT00099866
Principal SponsorNovartis Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

570 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
Not currently on durg therapy for type 2 diabetes
Body mass index (BMI) in the range 22-45
Blood glucose criteria must be met
6 exclusion criteria prevent from participating
Type 1 diabetes
Pregnancy or lactation
Evidence of serious diabetic complications
Evidence of serious cardiovascular conditions
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Novartis investigative Site

Investigative Sites, GermanyOpen Novartis investigative Site in Google Maps
CompletedOne Study Center