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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00390520
• Lead Sponsor: Novartis

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Study First Posted: 2006-10-20
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-07
• Last Update Submitted: 2020-02-08
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland