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| ID | Type | Description | Link |
|---|---|---|---|
| IND136121 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Southern Star Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Metformin XR Monotherapy | Active Comparator | Participants receive metformin XR 1000-2000 mg/day together with matching placebo capsules and tablets corresponding to celecoxib and valsartan. |
|
| Arm 2: TriGlytza Low Dose | Experimental | Participants receive metformin XR 1000-2000 mg/day together with celecoxib 100 mg once daily and valsartan 40 mg once daily. |
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| High-dose TriGlytza®-01 | Experimental | Participants receive metformin XR 1000-2000 mg/day together with celecoxib 200 mg once daily and valsartan 80 mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin XR | Drug | Metformin extended-release tablets administered orally once daily according to protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 16 weeks | |
| Proportion achieving HbA1c <7.0% | 16 weeks | |
| Change in fasting plasma glucose |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles Czank, PhD MBA | Contact | +61 2 8527 2453 | cczank@myopharm.com | |
| Kurt Sales, PhD PGCM | Contact | +61 2 8527 2453 | ksales@myopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Charles Czank | Myopharm Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniSC Clinical Trials | Maroochydore | Queensland | Australia | |||
| Momentum Sunshine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21233852 | Background | 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. | |
| 28330649 | Background | 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. Epub 2017 Mar 18. |
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Individual participant data are not planned to be shared.
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| Celecoxib | Drug | Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment. |
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| Valsartan | Drug | Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment. |
|
| 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) | Change in total body fat (%) measured using whole-body dual-energy X-ray absorptiometry (DEXA). | 16 weeks |
| Requirement for rescue therapy | 16 weeks |
| Maximum Plasma Concentration (Cmax) of Study Treatment Components | Plasma maximum observed concentration (Cmax) | 16 weeks |
| Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components | Time to maximum observed plasma concentration (Tmax) | 16 weeks |
| Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components | Plasma area under the concentration-time curve (AUC) | 16 weeks |
| Terminal Elimination Half-life (t½) of Study Treatment Components | Plasma terminal elimination half-life (t½) | 16 Weeks |
| Melbourne |
| Victoria |
| Australia |
| Momentum Darlinghurst | Sydney | Australia |
| Background | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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