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

ConditionType 2 Diabetes (Adult Onset)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

256 Participants
are divided into 4 treatment groups
Group A: Group ICExperimental treatment 2 interventions
Group B: Group IIActive comparator 2 interventions
Group C: Group IAActive comparator 2 interventions
Group D: Group 1BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)

Therapy failure will be determined as HbA1c \>6.5% in two consecutive HbA1c measurements 3 months apart. Time to cumulative incidence of therapy failure curves will be created in subjects receiving pioglitazone/tirzepatide versus subjects receiving metformin/sitagliptin

Time frame
6 months
2

Number of subjects failing to achieving HbA1c <6.5% Long-term

The failure to achieving HbA1c \<6.5% (Durability) at the end of study in subjects receiving pioglitazone/tirzepatide (Group I) versus metformin/sitagliptin (Group II) in two consecutive HbA1c measurements 3 months apart.

Time frame
month 60

Secondary outcomes

1

Change in insulin sensitivity

Matsuda Index of insulin sensitivity or total glucose disposal measured with the clamp.These are the gold standard methods for quantification insulin sensitivity with the OGTT or a euglycemic clamp

Time frame
from baseline to end of study (60 months)
2

Change in Beta Cell Function

A calculated value using plasma glucose, insulin and C-peptide concentrations during the Oral Glucose Tolerance Test (OGTT) test.

Time frame
Baseline to end of study (60 months)
3

Change in body weight

Change from study beginning to end, measured in kilograms (kg)

Time frame
Baseline to end of study (60 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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