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Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two pairs of medicines: pioglitazone plus tirzepatide and metformin plus sitagliptin. It looks at how well, how long, and how these medicines lower HbA1c, a measure of average blood sugar. It is for adults ages 18–75 who were diagnosed with type 2 diabetes within the past 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can understand the study and agree to sign a consent form.
  • Are 18–75 years old.
  • Were diagnosed with type 2 diabetes within the past 5 years.
  • Have not taken diabetes medicine, or take only metformin.
  • Have an HbA1c above 6.5%, with no upper limit.
  • Are willing to follow the study medicine plan and lifestyle rules.
  • Are in good overall health.
  • Have had a steady body weight for the past 3 months.

Who can't join

  • Test positive for anti-GAD antibodies, proteins made by the immune system.
  • Are pregnant or plan to become pregnant.
  • Have advanced diabetes-related eye disease with abnormal blood vessel growth.
  • Have a blood creatinine level above 1.4 for females or 1.5 for males. Creatinine is a measure of kidney function.
  • Have heart failure, meaning the heart does not pump blood well enough.
  • Have had cancer within the past 5 years, have bladder cancer, or have a family history of thyroid tumors.
  • Have ever had pancreatitis, or swelling of the pancreas.
  • Have blood in the urine on a urine test.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

TX