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The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00747968
First received: September 5, 2008
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  Purpose

30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Byetta, Exenatide
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of the GLP-1 Analogue Exenatide on Glucose Metabolism in the CNS and Heart During Hyperglycemia in Type-2 Diabetic Patients Assessed by PET

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo. [ Time Frame: oct. 2008 - oct 2010 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: glp-1-analogue
During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be heart OR CNS-PET scanned
 Drug: Byetta, Exenatide
Drug: Exenatide or placebo Dosage form: Infusion Dosage: Exenatide (Eli Lilly/Amylin Pharmaceuticals) 0.066 pmol*kg-1*min-1 Duration: 5 hours Frequency: Drug given once, placebo given once
Other Name: placebo
Placebo Comparator: placebo
During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be CNS OR heart-PET scanned.
 Drug: Byetta, Exenatide
Drug: Exenatide or placebo Dosage form: Infusion Dosage: Exenatide (Eli Lilly/Amylin Pharmaceuticals) 0.066 pmol*kg-1*min-1 Duration: 5 hours Frequency: Drug given once, placebo given once
Other Name: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signed
  • Caucasian
  • Male
  • Diabetes for > 6 months
  • Diet treatment or a single OAD (metformin, SU)
  • Age > 50 years and < 70 years
  • BMI 20-45 kg/m²
  • Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11% inclusive.
  • Fasting PG 7-10 mmol/l
  • OAD discontinued 72 hours prior to study day 1

Exclusion Criteria:

  • Clinically significant liver- or kidney-disease (se-ALAT > 2 times upper reference, or se-Creatinin > 130 mM
  • Anemia
  • Other abnormal biochemical value

  • Any of the following:

    • Heart disease
    • Liver disease
    • Kidney disease
    • Lung disease
    • Gastro-intestinal disease
    • Dyslipidemia (total serum-cholesterol > 8 mmol/l, total cholesterol/HDL cholesterol ratio > 8 or se-triglyceride > 3.5 mmol/l)
    • Endocrine disease (other than diabetes)
    • CNS disease
    • Hematological disease
    • Loss of more than 100 ml blood within the latest month of inclusion
    • Compliance problems
    • Abuse of alcohol or drugs
    • Smoking
    • Participation in a clinical research study within 3 months of inclusion
    • Allergy towards study hormones
    • Medication with any drugs with effects on the glucose-metabolism, including *glitazones
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747968

Locations
Denmark
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Aarhus C, Denmark, 8000
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Denmark, 8000 C
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Eli Lilly and Company
Aarhus University Hospital
Investigators
Principal Investigator: michael g jensen, MD Aarhus University, Institute of Pharmacology
Study Director: Jørgen Rungby, Professor Aarhus University, Institute of Pharmacology
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MD, michael gejl jensen, Aarhus University Hospital, Aarhus
ClinicalTrials.gov Identifier: NCT00747968     History of Changes
Other Study ID Numbers: Brainandheart
Study First Received: September 5, 2008
Last Updated: June 29, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013