Clinical trial

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

Opening soon · Phase 2, Phase 3 · 1 countries · Registry ID NCT06913023

Opening soonPhase 2, Phase 3Interventional

What this study is about

The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of placebo and semaglutide therapy in 74 KTR at risk of post-transplant diabetes mellitus (PTDM).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionKidney Transplant Recipient

Full registry criteria

Inclusion Criteria: 1. Signed and dated written informed consent. 2. Adult (≥18 years) recipients of a living or deceased donor kidney transplant 3. Between 4- and 12-weeks post kidney transplant 4. Stable kidney function defined as an eGFR \> 30 ml/min/1.73m2 (CKD-EPI) 5. At risk for PTDM at the time of transplant based on the following criteria: 1. BMI ≥ 25 kg/m2, or 2. Fasting plasma glucose 6.1-6.9 mmol/L (impaired fasting glucose), or 3. 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or 4. HbA1C 5.5-6.4% (at risk for DM or prediabetes). Exclusion Criteria: 1. Established diagnosis of type 1 or type 2 DM as per Diabetes Canada (including the need for glucose-lowering therapy for hyperglycemia at the time of screening) 2. Kidney-Pancreas transplant recipient 3. Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening 4. History of pancreatitis 5. Personal or family history of medullary thyroid cancer or MEN2B 6. Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial 7. Use of GLP1RA in the 30 days prior to screening 8. Contraindication to MRI (applicable only to those undergoing the optional MRI assessments) 9. With known or suspected hypersensitivity to semaglutide or related products 10. Patient not able to understand and comply with study requirements, based on Investigator's judgment. 11. Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcom 12. History of glucose-galactose malabsorption syndrome

Treatments and study arms

Semaglutide 3 MG [Rybelsus]

Drug

Semaglutide 3mg for 4 weeks.

Semaglutide 7 MG [Rybelsus]

Drug

Semaglutide 7mg for 4 weeks.

Semaglutide 14 MG [Rybelsus]

Drug

Semaglutide 14mg for 16 weeks.

Placebo Oral Tablet

Drug

Placebo tablet

Primary outcomes

2-hour OGTT24 weeks

The primary outcome of this study is the change in plasma glucose at 120 minutes following a 75g oral glucose challenge (2-hour OGTT) at 24 weeks. The 2-hour OGTT was selected as the primarily outcome in this study for the following reasons: 1) In selecting a surrogate outcome for PTDM in KTR, there are limitations to HbA1c and fasting glucose in this population; 2) The 2-hour OGTT is the recommended test for the diagnosis of PTDM in KTR and 3) The use of OGTT has been used in other PTDM prevention studies.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Toronto General Hospital🇨🇦 Toronto, Ontario, Canada
Vesta LaiContact
Sunita Singh, MD MSc FRCPCPrincipal Investigator
St. Paul's Hospital🇨🇦 Vancouver, British Columbia, Canada
Vikas S Srinivasan, MD FRCPCContact