DelfaGLP-1 Atlas

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RecruitingPhase 3

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

2

Recruiting sites

2

Enrollment

256

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•HbA1c <6.5% achievement

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06246799
Org study IDSTUDY00000139
Secondary IDR01DK097554

Timeline

Milestones

Study first posted2024-02-07actual
Study start2024-11-07actual
Last update posted2026-03-10actual
Primary completion2029-04-30estimated
Study completion2029-06-30estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

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

Time frame:6 months

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Primary/protocol endpoint

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

Time frame:month 60

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in insulin sensitivity

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

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Beta Cell Function

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.