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NCT00300287 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00300287
Other study ID # CLAF237A2307E1
Secondary ID
Status Completed
Phase Phase 3
First received March 6, 2006
Last updated July 31, 2017
Start date February 20, 2006
Est. completion date June 26, 2007

Study information
Verified date July 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 26, 2007
Est. primary completion date June 26, 2007
Accepts healthy volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Completion of study CLAF237A2307 within 4 weeks of entering into the extension

- Written informed consent

- Ability to comply with all study requirements

- Blood glucose criteria must be met

Exclusion Criteria:

- Premature discontinuation from study CLAF237A2307

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c at 108 weeks
Secondary Adverse event profile after 108 weeks of treatment
Secondary Change in HbA1c from week 52 to week 108
Secondary Change from baseline in fasting plasma glucose at week 108
Secondary Change in fasting plasma glucose from week 52 to week 108
Secondary Change from baseline in body weight at week 108
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