Clinical trial
Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Name
STUDY00000139
Description
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)
Trial arms
Trial start
2024-07-01
Estimated PCD
2029-04-01
Trial end
2029-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Group 1B, Group IA, Group IC
Other names:
Mounjaro
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.
Arms:
Group 1B, Group IA, Group IC
Other names:
Actos
Sitagliptin
Sitagliptin: will be administered as a 100mg dose once daily.
Arms:
Group II
Other names:
Januvia
Metformin HCI XR
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Arms:
Group II
Other names:
Extended Release Metformin
Size
730
Primary endpoint
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
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open label study. There are 2 groups, with 2 sub groups, 1A, 1B and 1C included within Group 1.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 730, 'type': 'ESTIMATED'}}
Updated at
2024-02-07
1 organization
3 products
1 drug
1 indication
Product
TirzepatideIndication
Type 2 DiabetesProduct
PioglitazoneDrug
SitagliptinProduct
Metformin HCI