Effect of Ozempic on stomach emptying, blood sugar levels and blood pressure after a high carbohydrate meal in people with type 2 diabetes

Phase 2

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12624000570583
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-06
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

•Male or female participants aged 40 – 80 years
•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.
•T2DM (World Health Organisation (WHO) criteria) managed by diet alone or on metformin
•Glycated haemoglobin (HbA1c) greater than or equal to 6.0% and less than or equal to 8.5%, in the last 4 months prior to enrolment in the study
•Body mass index (BMI) 25 – 40 kg/m2
•Haemoglobin and ferritin in the normal range for gender and age.
•Participant has provided written informed consent.

Exclusion Criteria

•Evidence of renal disease (i.e. a creatinine clearance cut-off of < 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)(24)
• Iron stores, or liver function tests outside the following ranges:
Alanine aminotransferase (ALT)< 55 U/L
Alkaline phosphatase (ALP)30 - 110 U/L
Aspartate transaminase (AST)< 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)
•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.
•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 = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to screening will be excluded.
•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.
•Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
•History of hyperthyroidism or uncontrolled hypothyroidism.
•Chronic gastrointestinal symptoms as assessed by questionnaire.
•Use of drugs potentially affecting gastrointestinal motility (corticosteroids; anti-emetics (dopamine antagonists, 5HT-3 receptor antagonists), laxatives, prokinetic agents, anticholinergic agents, cholinergic agents, opioid medications, erythromycin).
•Current use of anticoagulants.
•Inability to abstain from smoking for 12 hours prior to the gastric emptying tests.
•Consumption of greater than 2 units alcohol daily on a regular basis.
•Known or suspected history of alcohol or drug abuse, as judged by the Investigator.
•History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to semaglutide or drugs with a similar chemical structure or its components.
•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
•Participation in any research studies involving exposure to ionising radiation exceeding 2.5mSv in the previous 12 months
•Donated blood in the past 3 months
•Vegetarian

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of 12 weeks treatment with semaglutide QW (once weekly) versus placebo on gastric emptying in type 2 diabetes.[Scintigraphy - radiolabelled mashed potato meal Gastric emptying will be assessed at baseline (before drug), 12 weeks after drug and 1 and 4 weeks after cessation of the study drug.<br><br>On each day, gastric emptying will be assessed immediately after ingestion of the mashed potato meal (t=0 minutes) in dynamic mode i.e. in 1 min frames for the first 60 minutes and in 3-minute frames thereafter until t=180 minutes.<br><br>The primary outcome measure will be AUC0-180min.]