Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 :
Actual Primary Completion Date :
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Ages Eligible for Study:
30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 - 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.