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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: Byetta, Exenatide | Phase 2 Phase 3 |

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 |

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

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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 |
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
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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

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
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 |
Principal Investigator: | michael g jensen, MD | Aarhus University, Institute of Pharmacology | |
Study Director: | Jørgen Rungby, Professor | Aarhus University, Institute of Pharmacology |
Responsible Party: | MD, michael gejl jensen, Aarhus University Hospital, Aarhus |
ClinicalTrials.gov Identifier: | NCT00747968 |
Other Study ID Numbers: |
Brainandheart |
First Posted: | September 8, 2008 Key Record Dates |
Last Update Posted: | June 30, 2011 |
Last Verified: | June 2011 |
Diabetes Mellitus, Type 2 Hyperglycemia Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |