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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Not yet enrolling
Phase 3

Conditions

Type 2 Diabetes (Adult Onset)

Treatments

Drug: Pioglitazone
Drug: Metformin HCI XR
Drug: Sitagliptin
Drug: Tirzepatide

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06246799
R01DK097554 (U.S. NIH Grant/Contract)
STUDY00000139

Details and patient eligibility

About

The goal of this randomized, open labelled clinical trial is to examine the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus patients.

The main question[s] it aims to answer are:

How effective is the combination of pioglitazone plus tirzepatide in managing blood sugar levels in people with type 2 diabetes? How does this combination compare to the use of metformin plus sitagliptin in controlling blood sugar levels? Participants will receive Pioglitazone beginning at 15 mg daily and ending 45 mg daily. (15mg month 1, 30mg month 2 and 45mg at month 3 onwards)

Full 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.

Enrollment

730 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

730 participants in 4 patient groups

Group IC
Experimental group
Description:
Tirzepatide starting at 2.5mg weekly titrated to 15mg weekly (2.5 month 1, 5mg month 2, 10mg month 3 and 15mg at month 4) with Pioglitazone beginning at 15mg daily and ending at 45mg daily (15mg month 1, 30mg month 2 and 45mg at month 3 onwards).
Treatment:
Drug: Tirzepatide
Drug: Pioglitazone
Group II
Active Comparator group
Description:
Metformin starting at 1000mg XR daily and Sitagliptin 100mg daily at week 4, Metformin will be increased to 200mg.
Treatment:
Drug: Sitagliptin
Drug: Metformin HCI XR
Group IA
Active Comparator group
Description:
Tirzepatide will be started at 2.5mg and increased to 15mg by month 4. At month 6, Pioglitazone will be added to the Tirzepatide, 15 mg daily.
Treatment:
Drug: Tirzepatide
Drug: Pioglitazone
Group 1B
Active Comparator group
Description:
Pioglitazone will be started at 15mg and increased to 45 mg by month 3. At month 6, tirzepatide 2.5mg will be started and increased weekly as tolerated.
Treatment:
Drug: Tirzepatide
Drug: Pioglitazone

Trial contacts and locations

1

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Central trial contact

Gozde Baskoy, PhD; Muhammad Abdul-Ghani, MD

Data sourced from clinicaltrials.gov

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