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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.
Participants will be randomized 1:1:1 to three treatment arms: two PG-102(MG12) dose groups and one active-control group (dulaglutide), over a 32-week treatment period , with an additional 4-week safety follow-up.
PG-102(MG12) will be administered with a dose titration schedule: once weekly for the first 4weeks, once every 2 weeks for the following 4 weeks, and once every 4 weeks for the remaining 24 weeks.
The dulaglutide control group will continue their current maintenance dose once weekly per label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG-102(MG12) 60mg | Experimental | PG-102(MG12) 60 mg (N=20). Subcutaneous Injection with dose titration: Once weekly for 4 weeks, once every 2 weeks for 4 weeks, then once every 4 weeks for 24 weeks |
|
| PG-102(MG12) 90mg | Experimental | PG-102(MG12) 90 mg (N=20). Subcutaneous Injection with dose titration: Once weekly for 4 weeks, once every 2 weeks for 4 weeks, then once every 4 weeks for 24 weeks |
|
| Dulaglutide | Active Comparator | Continued dulaglutide at current maintenance dose (N=20). Subcutaneous injection once weekly per label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG-102(MG12) | Drug | GLP-1 and GLP-2 fusion protein |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from Baseline at Week 32 | Percent change in glycated hemoglobin (HbA1c, %) from baseline to Week 32 | [Time Frame: Baseline to Week 32] |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Number of participants with treatment-emergent adverse events (TEAEs) reported following administration of PG-102. | [Time Frame: Baseline to Week 36] |
| Percent Change in HbA1c from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
"17. Severe or active diabetic complications, including:
Proliferative diabetic retinopathy currently receiving or requiring treatment (laser, vitrectomy, anti-VEGF, or steroid injections) within the past 3 months or planned treatment. (Non-proliferative or stable retinopathy is permitted with fundus examination at screening and regular follow-up.)
Diabetic nephropathy with overt proteinuria (≥300 mg/day) or eGFR <45 mL/min/1.73 m²
Severe diabetic neuropathy with uncontrolled pain despite optimized pharmacotherapy (e.g., antidepressants, gabapentinoids, analgesics) for ≥3 months, requiring continuous use of opioid or multiple combination analgesics.
Exception: patients with past complications that are currently stable and deemed safe to participate as assessed by the investigator." 18. Fertile women or fertile men (including those with fertile female partners) who do not agree to use dual contraception or abstinence from the time of written consent until 90 days after the last dose of investigational product. (Fertile women must have a negative serum pregnancy test during screening prior to study entry).
19. Currently pregnant or breastfeeding, or planning pregnancy during the study period or within 90 days after the last dose of investigational product.
20. Previous experience of persistent or recurrent vomiting or severe diarrhea requiring hospitalization, emergency treatment, or drug discontinuation following GLP-1 receptor agonist or GLP-2 analogue administration, or history of intestinal obstruction.
21. Patients who required dose reduction of dulaglutide due to intolerance and subsequently failed re-escalation to the previous dose. Exception: patients assessed by the investigator as currently maintaining stable treatment at the reduced dose.
22. History of or planned use of prohibited concomitant medications within 90 days prior to screening or during the study period. Exception: short-term use (≤14 days) for therapeutic necessity with no anticipated pharmacokinetic or pharmacodynamic interaction with the investigational product as judged by the investigator.
23. Use of insulin for diabetes management during the 1 year prior to screening. Exception: acute short-term use (≤14 days) during hospitalization or perioperative periods.
24. Patients deemed inappropriate for study participation by the investigator based on safety, compliance, or medical judgment (considering physical examination, baseline test results, medical history, etc.).
25. Self-reported body weight change of >5% within 12 weeks (90 days) prior to screening.
26. History of untreatable colorectal polyps. 27. Presence of factors that may affect IGF-1 measurement, such as growth hormone (GH) injections.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youngmin Cho, MD | Contact | 82-2-6098-2818 | bd@progen.co.kr |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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This is a randomized, open-label, active-controlled study evaluating the efficacy and safety of PG-102 compared with dulaglutide in participants with type 2 diabetes mellitus
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| Dulaglutide |
| Drug |
GLP-1 receptor agonist |
|
Percent change in glycated hemoglobin (HbA1c, %) from baseline at Weeks 8, 12, 16, 20, 24, 28, and 36
| [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, and 36] |
| 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: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36] |
| 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: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36] |
| Percent Change in Body Weight from Baseline | Percent change in body weight from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36. | [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36] |
| Absolute Change in Body Weight from Baseline | Absolute change in body weight (kg) from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36. | [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36] |
| D004700 | Endocrine System Diseases |