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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

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ClinicalTrials.gov Identifier: NCT00747968
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : June 30, 2011
Sponsor:
Collaborators:
Eli Lilly and Company
Aarhus University Hospital
Information provided by:
University of Aarhus

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Byetta, Exenatide Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo. [ Time Frame: oct. 2008 - oct 2010 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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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 ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glucagon-Like Peptide 1
 Glucagon
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents