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
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
Treatments tested in this trial
- PG-102(MG12)
- Dulaglutide
Treatment groups
60 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov