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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00390520 |
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Date of registration:
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19/10/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes
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Scientific title:
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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. |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00390520 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 3
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Vildagliptin
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Primary Outcome(s)
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Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment
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Secondary Outcome(s)
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The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment
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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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Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose
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Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment
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Secondary ID(s)
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CLAF237A2386
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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