Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
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| ClinicalTrials.gov Identifier: NCT00651105 |
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Recruitment Status :
Completed
First Posted : April 2, 2008
Last Update Posted : November 18, 2016
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Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Type-2 Diabetes Healthy | Drug: Vildagliptin Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 63 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | February 2008 |
| Actual Primary Completion Date : | May 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: Vildagliptin |
| Placebo Comparator: 2 |
Drug: Placebo |
Primary Outcome Measures :
- GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects [ Time Frame: from baseline to Day 10 ]
Secondary Outcome Measures :
- Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects. [ Time Frame: 10 day treatment periods ]
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| Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Inclusion criteria - Type-2 Diabetes Patients
- Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and who are in otherwise good health
- 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
Inclusion Criteria - Healthy Volunteers
- 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:
Exclusion criteria - Type-2 Diabetes Patients
- A history of:
- 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
Exclusion Criteria - Healthy Volunteers
- 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.
Other protocol-defined inclusion/exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651105
Locations
| Germany | |
| Novartis Investigator Site | |
| Bad Lauterberg im Harz, Germany | |
| Novartis Investigator Site | |
| Berlin, Germany | |
Sponsors and Collaborators
Novartis
Investigators
| Principal Investigator: | Novartis | Novartis investigator site |
Publications of Results:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00651105 |
| Other Study ID Numbers: |
CLAF237A2347 |
| First Posted: | April 2, 2008 Key Record Dates |
| Last Update Posted: | November 18, 2016 |
| Last Verified: | November 2016 |
Keywords provided by Novartis:
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Diabetes Hyperglycemia Healthy Vildagliptin Adults |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin |
Hypoglycemic Agents Physiological Effects of Drugs Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |