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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Metformin XR
  Metformin extended-release tablets administered orally once daily according to protocol.
• Препарат Celecoxib
  Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
• Препарат Valsartan
  Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16. [Срок оценки: 16 weeks]

Вторичные конечные точки (10)

• Change in HbA1c [Срок оценки: 16 weeks]
• Proportion achieving HbA1c <7.0% [Срок оценки: 16 weeks]
• Change in fasting plasma glucose [Срок оценки: 16 weeks]
• Change in body weight [Срок оценки: 16 weeks]
• Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA) [Срок оценки: 16 weeks]
• Requirement for rescue therapy [Срок оценки: 16 weeks]
• Maximum Plasma Concentration (Cmax) of Study Treatment Components [Срок оценки: 16 weeks]
• Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components [Срок оценки: 16 weeks]
• Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components [Срок оценки: 16 weeks]
• Terminal Elimination Half-life (t½) of Study Treatment Components [Срок оценки: 16 Weeks]

Критерии участия

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.

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 3 центра

• UniSC Clinical Trials — Maroochydore
• Momentum Sunshine — Melbourne
• Momentum Darlinghurst — Sydney

Публикации

• 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.

Идентификаторы

NCT: NCT07139405 · MYP-001 · IND136121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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