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Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

Plain-language guide to NCT07677891: phase 2 randomized trial of Dulaglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07677891
Phase
phase 2
Status
not yet recruiting
Start
2026-10
Completion (planned or actual)
2027-05
Participants
60 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Type 2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Dulaglutide.

The treatment period is 32 weeks, with an additional 4-week safety follow-up.

The primary endpoint is the change in HbA1c(%) from baseline at Week 32.

It had three arms (groups): one (experimental), one (experimental) and Dulaglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 19 years up to 75 years.

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

Examples of who could join: Adults aged 19 to 75 years who provide informed consent. Diagnosed with type 2 diabetes for at least 6 months prior to screening. BMI between 18.5 kg/m² and 30.0 kg/m².

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: received any investigational medicinal product within 30 days prior to screening, or within 5 half-lives of the product if known (whichever is longer); history of hypersensitivity or severe adverse reactions to glp-1ra, glp-2 agents, the investigational product, or its components; type 1 diabetes, special forms of diabetes (e.g., monogenic, post-pancreatectomy, steroid-induced), or history of dka or hhs within 6 months prior to screening.

How the Study Was Run

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

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

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

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

It started in 2026-10 with completion listed for 2027-05.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c from Baseline at Week 32 (time frame: [Time Frame: Baseline to Week 32]).

It also tracked 6 secondary outcomes, for example Incidence of Treatment-Emergent Adverse Events (TEAEs), Percent Change in HbA1c from Baseline, Percent Change in Fasting Plasma Glucose (FPG) from Baseline, Absolute Change in Fasting Plasma Glucose (FPG) from Baseline, Percent Change in Body Weight from Baseline and Absolute Change in Body Weight from Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

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.