Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
Interventions
DRUGPG-102
PG-102 is administered subcutaneously once weekly with a titration regimen.
DRUGPlacebo
Placebo is administered subcutaneously once weekly.
DRUGSemaglutide
Open-label semaglutide is administered subcutaneously once weekly with titration regimen.
Sponsors
ProGen. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
PG-102 and Placebo are administered double-blind; the Semaglutide comparator arm is open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. * Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF). * Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria. * Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening. * Body mass index (BMI) ≥25 to \<40 kg/m2 at screening.
Exclusion criteria
* Have a diagnosis of type 1 diabetes. * History of severe hypoglycaemia and/or hypoglycaemia unawareness within 6 months prior to screening. * Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy. * History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening. * Diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator (or delegate). * Have known liver disease or obvious clinical signs or symptoms of liver disease, including acute or chronic hepatitis; or have any of the following at screening: ALT ≥ 3 × ULN, AST ≥ 3 × ULN, and total bilirubin ≥2 × ULN. * Concomitant therapy in addition to metformin therapy with another oral antihyperglycaemic medication (OAM) including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransport 2 inhibitors, alpha-glucosidase inhibitors, and meglitinides. Participants may be randomised if the additional OAM was discontinued at least 3 months prior to screening. * Have used insulin for diabetic control within the prior year; however, short-term use of insulin for acute conditions is allowed (≤14 days) in certain situations, such as during a hospitalisation or perioperatively. * Have had any exposure to GLP-1 analogues (including combination products) or other related compounds within the prior 3 months prior to screening, or any history ever of allergies to these medications. Patients who previously took GLP-1 analogues or related compounds and who discontinued those medications for intolerability or lack of efficacy will not be randomised. * Have been treated with prescription drugs that promote weight loss or similar body weight loss medications including over-the-counter medications within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in HbA1c From Baseline at Week 24 | 24 weeks | Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Body Weight From Baseline at Week 12 and 24 | 12 and 24 weeks | Mean absolute change in body weight from baseline to Weeks 12 and 24. |
| Percent Change in Body Weight From Baseline at Week 12 and 24 | 12 and 24 weeks | Mean percent change in Body Weight from baseline to Week 12 and 24. |
| Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24. | 12 and 24 weeks | Mean change in fasting plasma glucose (mg/dL) from baseline to Week 12 and 24. |
| Absolute change in HbA1c from baseline to 12 weeks | 12 weeks | Mean absolute change in HbA1c from baseline to Week 12. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 24 weeks | Number and percentage of participants experiencing TEAEs, SAEs, and discontinuations due to adverse events. |
| Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal | 24 weeks | Incidence and severity of GI-related AESIs (e.g., nausea, vomiting, diarrhea). |
| Incidence of anti-drug antibodies (ADA) to PG-102 | 24 weeks | Number and percentage of participants developing anti-drug antibodies against PG-102. |
| Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24. | 12 and 24 weeks | Mean change in the 7-point SMPG profile from baseline to Week 12 and 24. |
Countries
Australia
Contacts
Primary ContactKyunghwa Son, Ph.D
Backup ContactRosanna Sung
Outcome results
None listed