Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type-2 Diabetes, Healthy

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Vildagliptin<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects |  | from baseline to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects. |  | 10 day treatment periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Hyperglycemia, Healthy, Vildagliptin, Adults