Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes
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.
1 other identifier
interventional
28
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Sep 2006
Shorter than P25 for phase_3 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 19, 2006
CompletedFirst Posted
Study publicly available on registry
October 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFebruary 11, 2020
July 1, 2009
1 year
October 19, 2006
February 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Type 1 diabetes
- Acute metabolic diabetic complications
- Evidence of significant diabetic complications
- Insulin treatment within the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis
Basel, Switzerland
Related Publications (1)
Ahren B, Schweizer A, Dejager S, Dunning BE, Nilsson PM, Persson M, Foley JE. Vildagliptin enhances islet responsiveness to both hyper- and hypoglycemia in patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Apr;94(4):1236-43. doi: 10.1210/jc.2008-2152. Epub 2009 Jan 27.
PMID: 19174497DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 19, 2006
First Posted
October 20, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
February 11, 2020
Record last verified: 2009-07