Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

NCT00099892

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

NCT00102466

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

NCT00138567

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

NCT00102388

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

NCT00099931

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vildagliptin

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

Metformin

Group Type ACTIVE_COMPARATOR

Metformin Comparator

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vildagliptin

Intervention Type DRUG

Metformin Comparator

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LAF237A

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Not currently on durg therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No