Type 2 Diabetes (T2DM)
Conditions
Keywords
Type 2 Diabetes, Diabetes, Metformin, Myopharm, Valsartan, Celecoxcib
Brief summary
This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed
Detailed description
This is a multicentre, randomized, double-blind, active-controlled Phase 2a study evaluating TriGlytza®-01 in adults with Type 2 diabetes inadequately controlled on metformin therapy. Eligible participants will be randomized in a 1:1:1 ratio to metformin alone, low-dose TriGlytza®-01, or high-dose TriGlytza®-01. Treatment will continue for 16 weeks following screening. The study will evaluate safety, tolerability, glycaemic efficacy, body weight, pharmacokinetics, and selected metabolic biomarkers.
Interventions
DRUGMetformin XR
Metformin extended-release tablets administered orally once daily according to protocol.
DRUGCelecoxib
Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
DRUGValsartan
Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.
Sponsors
Myopharm Limited
Southern Star Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18 to 70 years. Confirmed diagnosis of Type 2 diabetes mellitus. Inadequate glycaemic control while receiving a stable dose of metformin. Inclusion Criteria: * Adults aged 18 to 70 years. * Confirmed diagnosis of Type 2 diabetes mellitus. * Inadequate glycaemic control while receiving a stable dose of metformin. * HbA1c within the protocol-defined screening range. * Body mass index (BMI) 25 to 40 kg/m². * Adequate renal function. * Able and willing to provide written informed consent and comply with study procedures.
Exclusion criteria
* Type 1 diabetes mellitus or history of diabetic ketoacidosis. * Use of prohibited glucose-lowering medications before screening. * Clinically significant renal, hepatic, gastrointestinal, cardiovascular, or other medical conditions that could interfere with study participation or safety. * Recent major cardiovascular event or unstable cardiovascular disease. * Previous bariatric surgery or recent treatment with anti-obesity medication. * Active infection or other uncontrolled medical condition. * Pregnant or breastfeeding, or unwilling to comply with protocol-required contraception. * Any condition that, in the investigator's opinion, would make participation unsuitable or compromise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16. | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 16 weeks | — |
| Proportion achieving HbA1c <7.0% | 16 weeks | — |
| Change in fasting plasma glucose | 16 weeks | — |
| Change in body weight | 16 weeks | — |
| Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA) | 16 weeks | Change in total body fat (%) measured using whole-body dual-energy X-ray absorptiometry (DEXA). |
| Requirement for rescue therapy | 16 weeks | — |
| Maximum Plasma Concentration (Cmax) of Study Treatment Components | 16 weeks | Plasma maximum observed concentration (Cmax) |
| Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components | 16 weeks | Time to maximum observed plasma concentration (Tmax) |
| Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components | 16 weeks | Plasma area under the concentration-time curve (AUC) |
| Terminal Elimination Half-life (t½) of Study Treatment Components | 16 Weeks | Plasma terminal elimination half-life (t½) |
Countries
Australia
Contacts
CONTACTCharles Czank, PhD MBA
CONTACTKurt Sales, PhD PGCM
STUDY_DIRECTORCharles Czank
Myopharm Limited
Outcome results
None listed