Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

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

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-06-30

Brief Summary

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

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

Related Clinical Trials

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

Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

NCT00138593

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

NCT00101712

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

A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

NCT00300287

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

NCT00237250

Prediabetic State

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

Interventions

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

vildagliptin

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No