Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Study Evaluates New Diabetes Treatments
Plain English Summary
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes is a Phase 3 clinical trial sponsored by The University of Texas Health Science Center at San Antonio studying Type 2 Diabetes (Adult Onset). Compares two combination therapies for newly diagnosed type 2 diabetes. Patients aged 18-75 with recent type 2 diabetes diagnosis can participate. Involves taking study drugs weekly and monthly, with regular check-ups. Alternative treatments include metformin and sitagliptin. The trial aims to enroll 256 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Ages 18-75, recently diagnosed type 2 diabetes, not pregnant, no cancer history. No history of pancreatitis, no severe heart issues, and no high creatinine levels. Good general health and stable weight for 3 months. Willing to follow lifestyle recommendations. This trial is studying Type 2 Diabetes (Adult Onset), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the treatments lower HbA1c levels, crucial for managing diabetes. The specific primary outcome measures are: number of subjects achieving HbA1c <6.5% at 6 months (Efficacy) (6 months); Number of subjects failing to achieving HbA1c <6.5% Long-term (month 60). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial fills a gap by comparing new combination therapies for type 2 diabetes, offering better management options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Type 2 Diabetes (Adult Onset), where improved treatment options are needed.
Investor Insight
Market size for diabetes treatments is large, with this trial potentially leading to new approved therapies. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about your eligibility and the benefits of participating. Expect weekly and monthly visits, and follow the study drug regimen. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 256 participants
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 Outcomes
- number of subjects achieving HbA1c <6.5% at 6 months (Efficacy) (6 months)
- Number of subjects failing to achieving HbA1c <6.5% Long-term (month 60)
Secondary Outcomes
- Change in insulin sensitivity (from baseline to end of study (60 months))
- Change in Beta Cell Function (Baseline to end of study (60 months))
- Change in body weight (Baseline to end of study (60 months))
Full Eligibility Criteria
Inclusion Criteria: 1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Males and females; Age 18-75 years 3. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients 4. Drug naïve or receiving metformin monotherapy 5. HbA1c \>6.5% (no limit on upper HbA1c value); 6. Willingness to adhere to the investigational product regimen 7. Good general health 8. Stable body weight over the preceding 3 months 9. Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: 1. positive anti-GAD (antibodies to glutamic acid decarboxylase) 2. pregnancy or plan of becoming pregnant 3. evidence of proliferative diabetic retinopathy, 4. plasma creatinine \>1.4 females or \>1.5 males; 5. presence of congestive heart failure (CHF); 6. history of cancer (\<5 years); 7. prior history of pancreatitis, 8. bladder cancer or family history of thyroid tumors; 9. presence of hematuria in the urine analysis.
Trial Locations
- University Health System Texas Diabetic Institute, San Antonio, Texas, United States
- UT Health Science Center, San Antonio, Texas, United States
Frequently Asked Questions
What is clinical trial NCT06246799?
NCT06246799 is a Phase 3 INTERVENTIONAL study titled "Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes." It is currently recruiting and is sponsored by The University of Texas Health Science Center at San Antonio. The trial targets enrollment of 256 participants.
What conditions does NCT06246799 study?
This trial investigates treatments for Type 2 Diabetes (Adult Onset). The primary condition under study is Type 2 Diabetes (Adult Onset).
What treatments are being tested in NCT06246799?
The interventions being studied include: Tirzepatide (DRUG), Pioglitazone (DRUG), Sitagliptin (DRUG), Metformin HCI XR (DRUG). 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.
What does Phase 3 mean for NCT06246799?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06246799?
This trial is currently "Recruiting." It started on 2024-11-07. The estimated completion date is 2029-06-30.
Who is sponsoring NCT06246799?
NCT06246799 is sponsored by The University of Texas Health Science Center at San Antonio. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06246799?
The trial aims to enroll 256 participants. The trial is currently recruiting and accepting new participants.
How is NCT06246799 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06246799?
The primary outcome measures are: number of subjects achieving HbA1c <6.5% at 6 months (Efficacy) (6 months); Number of subjects failing to achieving HbA1c <6.5% Long-term (month 60). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06246799 being conducted?
This trial is being conducted at 2 sites, including San Antonio, Texas (United States).
Where can I find official information about NCT06246799?
The official record for NCT06246799 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06246799. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06246799 testing in simple terms?
Compares two combination therapies for newly diagnosed type 2 diabetes. Patients aged 18-75 with recent type 2 diabetes diagnosis can participate.
Why is this trial significant?
This trial fills a gap by comparing new combination therapies for type 2 diabetes, offering better management options. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06246799?
Potential side effects include nausea, weight changes, and low blood sugar. Monitor your health closely and report any issues to the study team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06246799?
Ask your doctor about your eligibility and the benefits of participating. Expect weekly and monthly visits, and follow the study drug regimen. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06246799 signal from an investment perspective?
Market size for diabetes treatments is large, with this trial potentially leading to new approved therapies. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Involves taking study drugs weekly and monthly, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Type 2 Diabetes (Adult Onset) Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.