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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Metformin extended-release tablets administered orally once daily according to protocol.
Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.
UniSC Clinical Trials
Maroochydore, Queensland, Australia
Momentum Sunshine
Melbourne, Victoria, Australia
Momentum Darlinghurst
Sydney, Australia
Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.
Time frame: 16 weeks
Change in HbA1c
Time frame: 16 weeks
Proportion achieving HbA1c <7.0%
Time frame: 16 weeks
Change in fasting plasma glucose
Time frame: 16 weeks
Change in body weight
Time frame: 16 weeks
Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA)
Change in total body fat (%) measured using whole-body dual-energy X-ray absorptiometry (DEXA).
Time frame: 16 weeks
Requirement for rescue therapy
Time frame: 16 weeks
Maximum Plasma Concentration (Cmax) of Study Treatment Components
Plasma maximum observed concentration (Cmax)
Time frame: 16 weeks
Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components
Time to maximum observed plasma concentration (Tmax)
Time frame: 16 weeks
Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components
Plasma area under the concentration-time curve (AUC)
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Time frame: 16 weeks
Terminal Elimination Half-life (t½) of Study Treatment Components
Plasma terminal elimination half-life (t½)
Time frame: 16 Weeks