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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Glucagon; Vildagliptin

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.