Status:
COMPLETED
The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Eli Lilly and Company
Aarhus University Hospital
Conditions:
Type 2 Diabetes
Eligibility:
MALE
50-70 years
Phase:
PHASE2
PHASE3
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 c...
Detailed Description
Background Type 2 diabetes (T2D) is epidemically increasing throughout the world. T2D is frequently associated with multiple complications, where particularly the macrovascular complications in the fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00747968
Start Date
February 1 2010
End Date
March 1 2011
Last Update
June 30 2011
Active Locations (4)
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1
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Aarhus C, Denmark, 8000
2
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Aarhus, Denmark, 8000
3
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Denmark, 8000 C
4
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Denmark, 8000