TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin XR, Celecoxib, Valsartan.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-Blind, Randomized, Active-Controlled Phase 2a Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TriGlytza®-01 in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
Overview
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
- Drug Metformin XR
Metformin extended-release tablets administered orally once daily according to protocol. - Drug Celecoxib
Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment. - Drug Valsartan
Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.
Primary outcome measures
- Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16. [Time frame: 16 weeks]
Secondary outcome measures (10)
- 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) [Time frame: 16 weeks]
- Requirement for rescue therapy [Time frame: 16 weeks]
- Maximum Plasma Concentration (Cmax) of Study Treatment Components [Time frame: 16 weeks]
- Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components [Time frame: 16 weeks]
- Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components [Time frame: 16 weeks]
- Terminal Elimination Half-life (t½) of Study Treatment Components [Time frame: 16 Weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- UniSC Clinical Trials — Maroochydore
- Momentum Sunshine — Melbourne
- Momentum Darlinghurst — Sydney
Publications
- Donath MY, Shoelson SE. Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 2011 Feb;11(2):98-107. doi: 10.1038/nri2925. Epub 2011 Jan 14. PMID 21233852
- Seferovic JP, Claggett B, Seidelmann SB, Seely EW, Packer M, Zile MR, Rouleau JL, Swedberg K, Lefkowitz M, Shi VC, Desai AS, McMurray JJV, Solomon SD. Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial. Lancet Diabetes Endocrinol. 2017 May;5(5):333-340. doi: 10.1016/S2213-8587(17)30087-6. PMID 28330649
- El-Bahrawy H, Hegazy S, Farrag W, Werida R. Targeting inflammation using celecoxib with glimepiride in the treatment of obese type 2 diabetic Egyptian patients. Int J Diabetes Dev Ctries. 2015.
Identifiers
NCT: NCT07139405 · MYP-001 · IND136121