NCT00747968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

9 months

First QC Date

September 5, 2008

Last Update Submit

June 29, 2011

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo.

    oct. 2008 - oct 2010

Study Arms (2)

glp-1-analogue

ACTIVE COMPARATOR

During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be heart OR CNS-PET scanned

Drug: Byetta, Exenatide

placebo

PLACEBO COMPARATOR

During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be CNS OR heart-PET scanned.

Drug: Byetta, Exenatide

Interventions

Byetta, ExenatideDRUG

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

Also known as: placebo
glp-1-analogueplacebo

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Compliance problems
  • Abuse of alcohol or drugs
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital, Investigational Dept. M of Endocrinology

Aarhus, Aarhus C, 8000, Denmark

Location

Aarhus University Hospital, Investigational Dept. M of Endocrinology

Aarhus, Aarhus, 8000, Denmark

Location

Aarhus University Hospital, Investigational Dept. M of Endocrinology

Aarhus, 8000 C, Denmark

Location

Aarhus University Hospital, Investigational Dept. M of Endocrinology

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Gejl M, Sondergaard HM, Stecher C, Bibby BM, Moller N, Botker HE, Hansen SB, Gjedde A, Rungby J, Brock B. Exenatide alters myocardial glucose transport and uptake depending on insulin resistance and increases myocardial blood flow in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jul;97(7):E1165-9. doi: 10.1210/jc.2011-3456. Epub 2012 Apr 27.

    PMID: 22544917DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • michael g jensen, MD

    Aarhus University, Institute of Pharmacology

    PRINCIPAL INVESTIGATOR

  • Jørgen Rungby, Professor

    Aarhus University, Institute of Pharmacology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

March 1, 2011

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

DK(4)