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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00651105
First received: March 28, 2008
Last updated: November 5, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Type-2 Diabetes
Healthy
Drug: Vildagliptin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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 [ Time Frame: from baseline to Day 10 ] [ Designated as safety issue: No ]

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. [ Time Frame: 10 day treatment periods ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: February 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Vildagliptin
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651105

Locations
Germany
Novartis Investigator Site
Bad Lauterberg Im Harz, Germany
Novartis Investigator Site
Berlin, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00651105     History of Changes
Other Study ID Numbers: CLAF237A2347
Study First Received: March 28, 2008
Last Updated: November 5, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Diabetes
Hyperglycemia
Healthy
Vildagliptin
Adults

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Vildagliptin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 29, 2014