New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes
ConditionDiabetes Mellitus
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Group A (triple combination intensive therapy group)
Drug1\) Initiate with Tirzepatide 2.5 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, adjust Tirzepatide to 5.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 3) After 1 month, adjust Tirzepatide to 7.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. 4) After 1 month, adjust Tirzepatide to 10.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 5) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
Group B (standard therapy group)
Drug1\) Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After 1 month, if blood glucose remains uncontrolled, add Tirzepatide 2.5 mg qw; 4) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 5.0 mg qw; 5) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 7.5 mg qw; 6) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 10.0 mg qw.
Treatment groups
296 Participants
are divided into 2 treatment groupsGroup A: Group A (triple combination intensive therapy group)Experimental treatment 1 intervention
Group B: Group B (standard therapy group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diabetic remission rate
Diabetic remission rate at 6 months after discontinuation of medication (percentage of patients with HbA1c \<6.5% at 6 months after discontinuation of medication)
Time frame
6 months after discontinuation of medicationSecondary outcomes
1
Diabetic remission rate
Diabetic remission rate at 3 and 12 months after discontinuation of medication and the time of diabetic remission
Time frame
3 and 12 months after discontinuation of medication2
Time required to achieve glycemic goal
The time required to achieve glycemic goal(FBG \<6.1mmol/L, 2h PPG \<8.0mmol/L or HbA1c#6.5%)
Time frame
6 months of medication3
EQ-5D-5L questionnaires, quality of life
EQ-5D-5L questionnaires, assessment of quality of life. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame
At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication4
Incremental cost per additional remission
Incremental cost per additional remission at 6 months after discontinuation of medication
Time frame
6 months after discontinuation of medicationSponsors and contacts
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Source ClinicalTrials.gov
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