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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00237250
Other study ID # CLAF237A2357
Secondary ID
Status Completed
Phase Phase 3
First received October 9, 2005
Last updated May 4, 2012
Start date October 2005
Est. completion date July 2006

Study information

Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Blood glucose criteria must be met

- Body mass index (BMI) in the range 23-45

Exclusion Criteria:

- Diagnosis of diabetes

- Serious cardiovascular events within the past 6 months

- Use of insulin or any oral antidiabetic agent

- Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
vildagliptin


Locations

Country Name City State
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in area under the 0-2 hour prandial glucose curve at 12 weeks
Secondary Adverse event profile after 12 weeks of treatment
Secondary Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
Secondary Change in HOMA B at 12 weeks
Secondary Change in fasting insulin at 12 weeks
Secondary Change in fasting proinsulin/insulin ratio at 12 weeks
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