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

Conditions

• Type 2 Diabetes (Adult Onset)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — 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.
• Pioglitazone — DRUG
  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.
• Sitagliptin — DRUG
  Sitagliptin: will be administered as a 100mg dose once daily.
• Metformin HCI XR — DRUG
  Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.

Study Details

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.

Key Dates

Start date

Nov 7, 2024

Status verified

Mar 2026

Primary completion

Apr 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

256 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Group IC
  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).
• Active Comparator: Group II
  Metformin starting at 1000mg XR daily and Sitagliptin 100mg daily at week 4, Metformin will be increased to 200mg.
• Active Comparator: Group IA
  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.
• Active Comparator: Group 1B
  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.

Primary Outcome Measure

number of subjects achieving HbA1c <6.5% at 6 months (Efficacy) [ Time Frame: 6 months ]

Central Contacts

• Muhammad Abdul-Ghani, MD
  210-567-6691
  [email protected]
• Gozde Baskoy, PhD
  210-358-7200
  [email protected]

Locations (2)

Find similar trials in San Antonio, TX

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