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Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
This study is currently recruiting participants.
Verified by Novartis, March 2009
First Received: March 28, 2008   Last Updated: March 6, 2009   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00651105
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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 ]

Estimated Enrollment: 80
Study Start Date: September 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Vildagliptin
2: Placebo Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651105

Contacts
Contact: Novartis +41 61 324 1111

Locations
Germany
Novartis Investigator Site Recruiting
Bad Lauterberg im Harz, Germany
Contact: Novartis     +41 61 324 1111        
Novartis Investigator Site Recruiting
Berlin, Germany
Contact: Novartis     +41 61 324 1111        
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CLAF237A2347
Study First Received: March 28, 2008
Last Updated: March 6, 2009
ClinicalTrials.gov Identifier: NCT00651105     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Diabetes
Hyperglycemia
Healthy
Vildagliptin
Adults

Study placed in the following topic categories:
Metabolic Diseases
Glucagon
Diabetes Mellitus
Endocrine System Diseases
Healthy
Vildagliptin
Protease Inhibitors
Glucagon-Like Peptide 1
Dipeptidyl-Peptidase IV Inhibitors
Hyperglycemia
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Glucose Metabolism Disorders
Vildagliptin
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009