Clinical trial

TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy

Opening soon · Phase 2 · 1 countries · Registry ID NCT07139405

Opening soonPhase 2Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes (T2DM)

Full registry criteria

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.

Treatments and study arms

Metformin XR

Drug

Metformin extended-release tablets administered orally once daily according to protocol.

Celecoxib

Drug

Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.

Valsartan

Drug

Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.

Primary outcomes

Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.16 weeks

Study locations

3 locations were listed when this page was built. The first 40 are shown.

UniSC Clinical Trials🇦🇺 Maroochydore, Queensland, Australia

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Momentum Sunshine🇦🇺 Melbourne, Victoria, Australia

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Momentum Darlinghurst🇦🇺 Sydney, Australia

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