NCT Number: NCT00651105
Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
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.
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Notify MeKey information
Conditions
Age range
30 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Novartis Investigator Site, Bad Lauterberg im Harz, Germany
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects
Time frame: from baseline to Day 10
Secondary outcomes
-
Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.
Time frame: 10 day treatment periods
Sponsors and collaborators
Lead sponsor
Novartis
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2008
- Primary completion
- 2009
- First posted
- Apr 2, 2008
- Registry last updated
- Nov 18, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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