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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Eli Lilly and Company
• Treatments: Exenatide; Glucagon; Glucagon-Like Peptide 1

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