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

Novartis

Status and phase

Completed

Phase 3

Conditions

Healthy

Type-2 Diabetes

Treatments

Drug: Vildagliptin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00651105

CLAF237A2347

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.