Efficacy of REducing cardiometabolic risk with SEmaglutide in Type 1 diabetes

Phase 2

Recruiting

Conditions: type 1 diabetes
Metabolic and Endocrine - Diabetes
Cardiovascular - Coronary heart disease

Registration Number: ACTRN12623001277639

Lead Sponsor: Garvan Institute of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

Main study:
1. type 1 diabetes of greater than or equal to 2 years duration
2. body mass index greater than or equal to 25 kg/m2
3. HbA1c greater than or equal to 7.0%
4. at least one cardiovascular risk factor:
- history of microalbuminuria [urinary albumin:creatinine ratio greater than 2.5 mg/mmol for males, greater than 3.5 mg/mmol for females]
- hypertension [Blood pressure (BP) greater than 140/90mmHg] or anti-hypertensive treatment
- hyperlipidemia [Total Cholesterol(TC):High Density Lipoprotein (HDL) ratio greater than 6] or lipid lowering therapy
- current smoking

Sub-study (Pancreatic hormones and carotid femoral pulse wave velocity only in people without diabetes to provide comparative data for baseline measures in type 1 diabetes group):
1. body mass index greater than or equal to 25 kg/m2

Exclusion Criteria

Main and sub-study:
1. treatment with a GLP1 receptor agonist, metformin or SGLT2 inhibitor in the last 3 months
2. current or planned treatment with medications that affect glucose metabolism (i.e. glucocorticoids, antipsychotics, immunosuppressants)
3. previous or planned bariatric surgery during study period
4. diabetic ketoacidosis or severe hypoglycaemia in the last 12 months
5. eGFR less than 45 ml/min/1.73m2
6. evidence of significant liver disease (known cirrhosis, LFTs greater than 3x upper limit of normal)
7. known gastroparesis
8. history of pancreatitis or cholecystitis
9. pregnant, breastfeeding or female of childbearing potential not using adequate contraception
10. coronary event or stroke in the last 3 months
11. active or untreated proliferative diabetic retinopathy
12. personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
13. previous adverse reaction to semaglutide necessitating discontinuation

Sub-study:
1. diabetes mellitus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in arterial stiffness[Carotid femoral pulse wave velocity using applanation tonometry of carotid artery and thigh cuff baseline, 13 weeks and 26 weeks post initiation of treatment (primary endpoint), 12 weeks post cessation of treatment]

Secondary Outcome Measures