Obesity Treatment to Improve Diabetes

NCT05390307 · Completed

Last updated 2026-05-28

This clinical trial is testing whether a new obesity treatment helps people with Type 1 diabetes manage their weight.

Status Completed The study has finished.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 60 people

Who can join Ages 21–65 · all sexes

Timeline Started 2023-04 · est. completion 2024-01

Where 1 site · Kuwait

What this study is testing ClinicalTrials.gov NCT05390307 ↗

Description as written by the study sponsor.

As the obesity pandemic continues unabated, one can expect to see an increase in the prevalence of TID/T2D and associated CKD. As a result, death will rise, preceded by an increase in kidney failure, requiring dialysis and renal transplantation. Innovative medical treatment may help prevent chronic kidney disease (CKD) across our healthcare system. The guideline of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) suggest that patients with obesity, TID/ T2D, and CKD needed either glucagon-like peptide 1 receptor analogs (GLP1-RA) or sodium-glucose cotransport-2 inhibitors (SGLT2i). If neither achieve metabolic control, then the recommendation is to combine both drugs. The evidence base for combining GLP1RA and SGLT2i are not well developed, and hence the impact of the guidelines are limited. This study will provide evidence of discrete metabolic pathways by the GLP1RA/or SGLT2i alone or in combination contributed to metabolic control. The aim of this randomised control trial (RCT) is to test the impact of the combination of GLP1RA/SGLT2i on body weight and kidney damage, in patients with T1DM and CKD. In addition, we will explore associated changes in metabolic pathways with each of the treatments used in the RCT.

Treatments tested

Liraglutide / Semaglutide also known as GLP1RA alone Drug

Liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection for 6 months.
Dapagliflozin also known as SGLT2i alone Drug

Dapagliflozin 5-10 mg once daily for 6 months.
Liraglutide or Semaglutide / Dapagliflozin also known as Combination of GLP1RA and SGLT2i Drug

Combined treatment with Liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection plus Dapagliflozin 5-10 mg once daily for 6 months.
Liraglutide or Semaglutide / Dapagliflozin plus intensive weight loss nutrition also known as Combination of GLP1RA, SGLT2i and intensive weight loss nutrition Drug

Liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection plus Dapagliflozin 5-10 mg once daily for 6 months combined with intensive lifestyle changes.
Usual care Other

Usual standard care

Main thing measured	Weight
Sponsor	Dasman Diabetes Institute
Conditions studied	Type 1 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05390307 ↗