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

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-75
SponsorProGen. Co., Ltd.

About this trial

This is a randomized, open-label, multi-center, active-controlled Phase 2 clinical trial to evaluate the efficacy and safety of switching from once-weekly dulaglutide to PG-102(MG12) in patients with type 2 diabetes mellitus receiving stable dulaglutide therapy.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 to 75 years who provide informed consent.

Diagnosed with type 2 diabetes for at least 6 months prior to screening.

Stable on dulaglutide therapy (0.75 or 1.5 mg) for at least 12 weeks prior to screening, with dose and dosing interval maintained unchanged for 8 weeks prior to enrollment.

HbA1c ≤ 7.5% at screening.

Disqualifiers

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

Severe gastrointestinal disorders affecting gastric emptying (e.g., gastroparesis, inflammatory bowel disease, gastric/duodenal ulcer, intestinal obstruction) or history of related surgery within the past year (e.g., sleeve gastrectomy, biliopancreatic diversion, jejunal/ileal bypass).

Trial design

Design model

Parallel

Treatments tested in this trial

  • PG-102(MG12)

    Drug

    GLP-1 and GLP-2 fusion protein

  • Dulaglutide

    Drug

    GLP-1 receptor agonist

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: PG-102(MG12) 60mgExperimental treatment 1 intervention
Group B: PG-102(MG12) 90mgExperimental treatment 1 intervention
Group C: DulaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c from Baseline at Week 32

Percent change in glycated hemoglobin (HbA1c, %) from baseline to Week 32

Time frame
[Time Frame: Baseline to Week 32]

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Number of participants with treatment-emergent adverse events (TEAEs) reported following administration of PG-102.

Time frame
[Time Frame: Baseline to Week 36]
2

Percent Change in HbA1c from Baseline

Percent change in glycated hemoglobin (HbA1c, %) from baseline at Weeks 8, 12, 16, 20, 24, 28, and 36

Time frame
[Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, and 36]
3

Percent Change in Fasting Plasma Glucose (FPG) from Baseline

Percent change in fasting plasma glucose (FPG, mg/dL) from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36.

Time frame
[Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
4

Absolute Change in Fasting Plasma Glucose (FPG) from Baseline

Absolute change in fasting plasma glucose (FPG, mg/dL) from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36.

Time frame
[Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ProGen. Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: