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Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control

Plain-language guide to NCT07244003: phase 4 randomized trial of Liraglutide, 430 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07244003
Phase
phase 4
Status
recruiting participants
Start
2025-03-29
Completion (planned or actual)
2027-12-31
Participants
430 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
T2DM (Type 2 Diabetes Mellitus)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Liraglutide.

It had two arms (groups): Met+SGLT-2i+GLP-1RA (experimental) and Triple Therapy of Other Oral Antidiabetic Drugs (active comparator).

Metformin+Ganagliflozin+Liraglutide.

Building upon the previously stable treatment regimen, the addition of 1-2 oral hypoglycemic agents (excluding SGLT-2 inhibitors and oral GLP-1 receptor agonists) constitutes a triple oral hypoglycemic regimen.

The registry classes the interventions as drug.

Who Took Part

The registry lists 430 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Body mass index (BMI) ≥20kg/m² ;. Volunteer to participate in this study and sign informed consent.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: patients with type 1 diabetes or other special types of diabetes;; patients with acute complications of ketoacidosis/hyperglycemic hyperosmolar state/lactic acidosis within 6 months before screening; those who received insulin treatment within the previous week.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2025-03-29 with completion listed for 2027-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The change of HbA1c compared to the baseline (time frame: from baseline to week 24).

It also tracked 9 secondary outcomes, for example The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets, The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning, The changes of waist circumference and hip circumference compared to the baseline, Changes in systolic and diastolic blood pressure compared to the baseline, The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline and The changes of body mass compared to the baseline.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 430 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.