New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

The goal of this clinical trial is to learn the efficacy of combination therapy with tirzepatide, empagliflozin and pioglitazone versus standard therapy in newly diagnosed type 2 diabetes. The main objectives to achieve are:

1. To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM. 2. To compare the effects on β-cell function and glycemic control of the triple combination therapy against standard therapy in patients newly diagnosed with T2DM Researchers will compare drug new triple combination therapy with tirzepatide, empagliflozin, and pioglitazone to standard therapy (metformin based treatment) to see if new triple combination therapy works better in achieving type 2 diabetes remission.

Participants will:

1. Take new triple combination therapy or a standard therapy every day for 6 months 2. Visit the clinic once every 0.5-1 month for checkups and tests 3. Keep a diary of their fingertip blood glucose and adverse events

Eligibility criteria

Qualifiers

Male or female, 18 years≤age≤75 years at the time of signing informed consent.

Newly diagnosed with type 2 diabetes, or diagnosed within 1 years according to the WHO diagnostic criteria.

Individuals who had not received previous antidiabetic therapy, or had not received antidiabetic therapy within 3 months prior to screening, or had not received antidiabetic therapy for more than 3 consecutive months or a combined total of more than 3 months in the past 2 years.

6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.

Disqualifiers

Individuals with type 1 diabetes or special types of diabetes.

Allergy or intolerance to investigational drugs.

Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².

Individuals with heart failure in New York Heart Association [NYHA] class III or IV in the 6 months prior to randomization.

Trial design

Treatments tested in this trial

  • Group A (triple combination intensive therapy group)
  • Group B (standard therapy group)

Treatment groups

296 Participants
are divided into 2 treatment groups

Sponsors and collaborators