Improving Glucose Outcomes Using a Novel Treatment Strategy in Young Adult Onset Type 2 Diabetes

Phase 4

Completed

• Conditions: Young Adult Onset Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000480381
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-03
• Study Completion: 2019-09-06
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Recent diagnosis of type 2 diabetes (< 6 months since diagnosis)
Age range: 18 to 40 years of age
Diabetes management at time of recruitment: diet alone or metformin monotherapy

Exclusion Criteria

Type 1 diabetes / GAD or IA2 positive diabetes
Current pregnancy
HbA1c <6.5% at time of screening
Contraindication to metformin, SGLT2 inhibitor or GLP-1 receptor agonist treatment
History of diabetic ketoacidosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control assessed by HbA1c. HbA1c will be measured on a sample of whole blood using an IFCC standardised method.[12 months]

Secondary Outcome Measures

Name	Time	Method
Change in beta-cell function. Beta-cell function will be primarily assessed indirectly from the results obtained during oral glucose tolerance testing and will include the derivation of the oral disposition index (ODI).[12 months (with reference point being beta-cell function at baseline)];Markers of renal function (including serum creatinine, eGFR, urinary albumin to creatinine ratio plus additional novel serum and urinary biomarkers)[12 months (with reference point being the baseline assessment)]