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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00651105

Collaborator

(none)

Enrollment

Locations

Arms

31.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type-2 Diabetes Healthy	Drug: Vildagliptin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Vildagliptin
Placebo Comparator: 2	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 1

Drug: Vildagliptin

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.