Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirzepatide, Pioglitazone, Sitagliptin, Metformin HCI XR.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (Adult Onset). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Overview
The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.
Detailed description
This is a randomized open label controlled 2 arm study (with one of the arms containing 3 sub-groups) which aims to examine the effectiveness and long term effects on HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (T2DM) patients.
A subgroup of patients from group 1 will be invited to participate in a sub-study which lasts for 6 months and aims at exploring the metabolic/molecular mechanisms responsible for the study results. The selection of subjects to each subgroup will be done randomly and the end of sub-study, subjects will continue therapy and follow-up from month 6 on in the main study.
Interventions
- Drug Tirzepatide
Tirzepatide:Participants will be initiated on 2.5mg weekly and increase their dose to 5mg at week 4, 10mg at week 8 and 15mg at week 12 as tolerated. - Drug Pioglitazone
Pioglitazone: Participants will begin therapy at 15mg daily for the first 4 weeks then increase dose to 30mg at week 4 and to 45 mg at week 8, as tolerated. - Drug Sitagliptin
Sitagliptin: will be administered as a 100mg dose once daily. - Drug Metformin HCI XR
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Primary outcome measures
- number of subjects achieving HbA1c <6.5% at 6 months (Efficacy) [Time frame: 6 months]
- Number of subjects failing to achieving HbA1c <6.5% Long-term [Time frame: month 60]
Secondary outcome measures (3)
- Change in insulin sensitivity [Time frame: from baseline to end of study (60 months)]
- Change in Beta Cell Function [Time frame: Baseline to end of study (60 months)]
- Change in body weight [Time frame: Baseline to end of study (60 months)]
Eligibility criteria
Inclusion criteria
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18-75 years
- Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients
- Drug naïve or receiving metformin monotherapy
- HbA1c >6.5% (no limit on upper HbA1c value);
- Willingness to adhere to the investigational product regimen
- Good general health
- Stable body weight over the preceding 3 months
- Agreement to adhere to Lifestyle Considerations throughout study duration.
Exclusion criteria
- positive anti-GAD (antibodies to glutamic acid decarboxylase)
- pregnancy or plan of becoming pregnant
- evidence of proliferative diabetic retinopathy,
- plasma creatinine >1.4 females or >1.5 males;
- presence of congestive heart failure (CHF);
- history of cancer (<5 years);
- prior history of pancreatitis,
- bladder cancer or family history of thyroid tumors;
- presence of hematuria in the urine analysis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- University Health System Texas Diabetic Institute — San Antonio
- UT Health Science Center — San Antonio
Identifiers
NCT: NCT06246799 · STUDY00000139 · R01DK097554