Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

What Was Tested

This registered not phased trial tested Tirzepatide and Semaglutide.

It had seven arms (groups): Dulaglutide (active comparator), semaglutide (active comparator), Loseenatide (active comparator), tirzepatide (active comparator) and elbenatide (active comparator).

Once a week, subcutaneous injection.

Once a week, subcutaneous injection.

Once a week, subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

This study intends to follow up for 1-4 years.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed type 2 diabetes according to the 1999 WHO standards;. Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG);. Be willing to sign written informed consent and comply with the study protocol.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening;; history of acute and chronic pancreatitis; a history of medullary c-cell carcinoma, men (multiple endocrine tumors) 2a or 2b syndrome, or related family history;; tumors of any organ system that have been treated or not treated in the 5 years prior to screening;.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-08-01 with completion listed for 2024-01-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effects of different GLP-1 on blood glucose (time frame: 1,2,3,4 year).

It also tracked 1 secondary outcome, for example Effects of different GLP-1 on body fat mass.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tirzepatide and Semaglutide in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.