Effect of exenatide once weekly on gastric emptying in type 2 diabetes
- Conditions
- Type 2 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12619000497101
- Lead Sponsor
- niversity of Adelaide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
1. Male or female participants aged 40 – 80 years
2. Female subjects who are post-menopausal; or pre-menopausal with surgical contraception (such as tubal ligation) or an intrauterine device. Pre-menopausal women will require a confirmed negative urine ß-hCG pregnancy test at screening visit.
3. T2DM (World Health Organisation (WHO) criteria) managed by diet alone or on metformin
4. Glycated haemoglobin (HbA1c) greater than or equal to 6.0% and less than 8.5%, in the last 4 months prior to enrolment in the study
5. Body mass index (BMI) 25 – 35 kg/m2
6. Haemoglobin and ferritin in the normal range for gender and age.
7. Participant has provided written informed consent.
1. Evidence of renal disease (i.e. a creatinine clearance cut-off of less than 50 ml/min. Calculated creatinine clearance will be determined as follows using the Cockcroft-Gault equation: Cr clearance = [140 - age (years) x weight (kg)] / [0.814 x serum creatinine (µmol/L)] (For female subjects, multiply Cr clearance x 0.85)13)
2. Iron stores, or liver function tests outside the following ranges:
Alanine aminotransferase (ALT)less than 55 U/L
Alkaline phosphatase (ALP)30 - 110 U/L
Aspartate transaminase (AST)less than 45 U/L
Total bilirubin6 - 24 µmol/L
Haemoglobin115 – 155 g/L (Females); 135 – 172 g/L (Males)
Ferritin15 – 200 µg/L (Females); 30 – 300 µg/L (Males)
3. Hepatic or cardiovascular disease, pancreatitis (subjects with past history of acute or chronic pancreatitis, gastric surgery, or known gastroparesis on history or screening biochemistry tests.
4. Participants with any history of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy at least 12 months prior to screening or other malignancies treated with apparent success with curative therapy at least 5 years prior to screening will be excluded.
5. History of any clinically significant disease or disorder which may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study.
6. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
7. History of hyperthyroidism or uncontrolled hypothyroidism.
8. Chronic gastrointestinal symptoms as assessed by questionnaire.
9. Use of drugs potentially affecting gastrointestinal motility (nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids; histamine-2 receptor antagonists, anti-emetics (dopamine antagonists, 5HT-3 receptor antagonists), laxatives, prokinetic agents, anticholinergic agents, cholinergic agents, opioid medications, erythromycin).
10.Current use of anticoagulants.
11. Inability to abstain from smoking for 12 hours prior to the gastric emptying tests.
12. Consumption of more than 2 units alcohol daily on a regular basis.
13. Known or suspected history of alcohol or drug abuse, as judged by the Investigator.
14. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to exenatide or drugs with a similar chemical structure or its components.
15. Known hypersensitivity to IV infusion equipment, plastics, adhesive or silicone, or know history of hypotension or infusion site reactions with IV administration of other medicines
16. Participation in any research studies involving exposure to ionising radiation within the previous 12 months
17. Donated blood in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of 8 weeks treatment with exenatide QW (once weekly) versus placebo on gastric emptying, measured by scintigraphy, in type 2 diabetes.[ 8 weeks]
- Secondary Outcome Measures
Name Time Method