Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00651105
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 2008
Actual Primary Completion Date : May 2009

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00651105

Layout table for location information
Novartis Investigator Site
Bad Lauterberg im Harz, Germany
Novartis Investigator Site
Berlin, Germany
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Novartis Novartis investigator site
Publications of Results:
Layout table for additonal information
Responsible Party: Novartis Identifier: NCT00651105    
Other Study ID Numbers: CLAF237A2347
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action