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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651105
• Other study ID #: CLAF237A2347
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2008
• Last updated: November 16, 2016
• Start date: February 2008

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy
• Type-2 Diabetes

Intervention

Drug:
• Vildagliptin

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Bad Lauterberg im Harz
Germany	Novartis Investigator Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Nauck MA, Kind J, Köthe LD, Holst JJ, Deacon CF, Broschag M, He YL, Kjems L, Foley J. Quantification of the Contribution of GLP-1 to Mediating Insulinotropic Effects of DPP-4 Inhibition With Vildagliptin in Healthy Subjects and Patients With Type 2 Diabet — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Results for CLAF237A2347 from the Novartis Clinical Trials website