A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351585
• Other study ID #: CLAF237A2344
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2006
• Last updated: May 4, 2012
• Start date: July 2004
• Est. completion date: September 2005

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

Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with type 2 diabetes for at least 6 months

• Patients whose diabetes is controlled by diet and exercise only or patients taking metformin

• BMI in the range 22-45

• Blood glucose criteria must be met

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes or diabetes resulting from pancreatic injury

• Cardiovascular complications as defined by the protocol

• Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Vildagliptin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in maximal insulin secretory capacity at 12 weeks
Primary	Durability of this effect after a 2-week washout
Secondary	Change from baseline in beta-cell sensitivity to glucose at 12 weeks
Secondary	Durability of this effect after a 2-week washout
Secondary	Chance from baseline in glucagon secretion at 12 weeks