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NCT00390520 Clinical Trial

Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on Glucagon Counterregulatory Response During Hypoglycemia in Patients With Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00390520
Other study ID # CLAF237A2386
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2006
Est. completion date September 2007

Study information
Verified date July 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months

- >/= 18 years

- Body mass index in the range of 22-35 kg/m2

- HbA1c </=7.5%

Exclusion Criteria:

- Type 1 diabetes

- Acute metabolic diabetic complications

- Evidence of significant diabetic complications

- Insulin treatment within the past 6 months

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment
Secondary Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment
Secondary The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment
Secondary Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose
Secondary Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events
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