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

Phase 3

Completed

• Conditions: Type-2 Diabetes; Healthy
• Interventions: Drug: Placebo; Drug: Vildagliptin

• Registration Number: NCT00651105
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Primary Completion: 2009-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects	from baseline to Day 10

Secondary Outcome Measures

Name	Time	Method
Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.	10 day treatment periods

Trial Locations

Locations (1)

Novartis Investigator Site; 🇩🇪 Berlin, Germany