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NCT00351507 Clinical Trial

A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00351507
Other study ID # CLAF237A2343
Secondary ID
Status Completed
Phase Phase 3
First received July 11, 2006
Last updated May 4, 2012
Start date May 2005
Est. completion date February 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

This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosed with type 2 diabetes for at least 6 months

- Blood glucose criteria must be met

- BMI in the range 22-40

Exclusion Criteria:

- History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

- Use of thiazolidinediones or need for insulin within 3 months prior to screening

- Significant concomitant diseases or complications of diabetes

- High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on gastric emptying
Secondary Effect on gastric volume
Secondary Effect on satiety
Secondary Effect on endogenous glucose appearance, glucose appearance and glucose disposal
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