Status:
COMPLETED
Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
Lead Sponsor:
Novartis
Conditions:
Type-2 Diabetes
Healthy
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00651105
Start Date
February 1 2008
Last Update
November 18 2016
Active Locations (2)
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1
Novartis Investigator Site
Bad Lauterberg im Harz, Germany
2
Novartis Investigator Site
Berlin, Germany