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

ConditionType 2 Diabetes (T2DM)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMyopharm Limited

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Arm 1: Metformin XR MonotherapyActive comparator 1 intervention
Group B: Arm 2: TriGlytza Low DoseExperimental treatment 3 interventions
Group C: High-dose TriGlytza®-01Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.

Time frame
16 weeks

Secondary outcomes

1

Change in HbA1c

Time frame
16 weeks
2

Proportion achieving HbA1c <7.0%

Time frame
16 weeks
3

Change in fasting plasma glucose

Time frame
16 weeks
4

Change in body weight

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myopharm Limited

Lead sponsor

Southern Star Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: