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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00651105 |
The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon secretion, using treatment observations of the overall glycemic response.
Condition | Intervention | Phase |
---|---|---|
Type-2 Diabetes Healthy |
Drug: Vildagliptin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomized, Cross-Over Study to Evaluate the GLP-1-Mediated and Non-GLP-1-Mediated Effects of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects |
Estimated Enrollment: | 80 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Vildagliptin |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion criteria - Type-2 Diabetes Patients
Inclusion Criteria - Healthy Volunteers
Exclusion Criteria:
Exclusion criteria - Type-2 Diabetes Patients
Exclusion Criteria - Healthy Volunteers
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis | +41 61 324 1111 |
Germany | |
Novartis Investigator Site | Recruiting |
Bad Lauterberg im Harz, Germany | |
Contact: Novartis +41 61 324 1111 | |
Novartis Investigator Site | Recruiting |
Berlin, Germany | |
Contact: Novartis +41 61 324 1111 |
Principal Investigator: | Novartis | Novartis investigator site |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLAF237A2347 |
Study First Received: | March 28, 2008 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00651105 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Diabetes Hyperglycemia Healthy Vildagliptin Adults |
Metabolic Diseases Glucagon Diabetes Mellitus Endocrine System Diseases Healthy Vildagliptin Protease Inhibitors |
Glucagon-Like Peptide 1 Dipeptidyl-Peptidase IV Inhibitors Hyperglycemia Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Enzyme Inhibitors Glucose Metabolism Disorders Vildagliptin Pharmacologic Actions Protease Inhibitors |