Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
NCT ID: NCT00651105
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
63 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
Vildagliptin
2
Placebo
Interventions
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Vildagliptin
Placebo
Eligibility Criteria
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Inclusion Criteria
* Must have been diagnosed with T2DM at least 6 months prior to screening, and whose diabetes is controlled by diet and exercise alone or by stable dosage ( \> 3 months) of metformin
* HbA1c in the range of 6.5% to 9% at screening
* Male or female subjects aged 30 to 75 years, determined to be in good health
* Normal oral glucose tolerance test (OGTT) at screening
* Age, gender and weight matched to subjects with T2DM
Exclusion Criteria
* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly
* Acute metabolic diabetic complications (such as ketoacidosis or hyperosmolar state (coma)) within the past 6 months
* Torsades de Pointes, ventricular tachycardia or ventricular fibrillation
* Any severe hypoglycemic episode within 3 months of screening
* Use of any of the following medications:
* Antihypertensive or lipid-lowering agents unless on a stable dose for at least 3 months prior to screening
* Chronic insulin treatment (\> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
* Chronic oral/intramuscular/intravenous corticosteroid treatment ( \> 7 consecutive days of treatment) within 8 weeks prior to screening
* First degree relative of an individual with T2DM
* History of gestational diabetes
* Use of any prescription medication within 1 month prior to dosing. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
30 Years
75 Years
ALL
Yes
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Novartis investigator site
Locations
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Novartis Investigator Site
Bad Lauterberg im Harz, , Germany
Novartis Investigator Site
Berlin, , Germany
Countries
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References
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Nauck MA, Kind J, Kothe LD, Holst JJ, Deacon CF, Broschag M, He YL, Kjems L, Foley J. Quantification of the Contribution of GLP-1 to Mediating Insulinotropic Effects of DPP-4 Inhibition With Vildagliptin in Healthy Subjects and Patients With Type 2 Diabetes Using Exendin [9-39] as a GLP-1 Receptor Antagonist. Diabetes. 2016 Aug;65(8):2440-7. doi: 10.2337/db16-0107. Epub 2016 Apr 5.
Other Identifiers
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CLAF237A2347
Identifier Type: -
Identifier Source: org_study_id