DelfaGLP-1 Atlas

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CompletedPhase 1Results posted

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

The Effect of Tirzepatide on α and β Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

Assets

Semaglutide / Tirzepatide

Listed sites

2

Recruiting sites

—

Enrollment

117

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7-9.5%

Primary endpoint

•Total Clamp Disposition Index (cDI)

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 IDNCT03951753
Org study ID17091
Secondary ID2018-003343-37
Secondary IDI8F-MC-GPGTEli Lilly and Company

Timeline

Milestones

Study first posted2019-05-15actual
Study start2019-06-28actual
Primary completion2021-04-08actual
Study completion2021-04-08actual
Last update posted2023-03-20actual
Results first posted2023-03-20actual

Assets

Investigational agents

SemaglutideTirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age74 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have T2DM for at least 6 months
•Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
•Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
•Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) >3 months prior to screening

Exclusion criteria

•Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination
•Impaired renal estimated glomerular filtration rate (eGFR) <45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
•Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data

Endpoints (18)

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
13
Other (unclassified)
4
Other clinical outcomes
1

Glycemic / diabetes

13 endpoints
Primary/registry result

Change From Baseline in Total Clamp Disposition Index (cDI)

Time frame:Baseline, Week 28

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), pmol*m-2*L*min-2*kg-195% CI
Tirzepatide 15 mg1.9—
Semaglutide 1 mg1.1—
Placebo0.0—
Least Squares Mean Difference1.0895% CI0.87 – 1.29p<0.001ANCOVA
Least Squares Mean Difference1.9295% CI1.59 – 2.24p<0.001ANCOVA
Least Squares Mean Difference0.8495% CI0.46 – 1.21p<0.001ANCOVA
Primary/protocol endpoint

Change From Baseline in Total Clamp Disposition Index (cDI)

Time frame:Baseline, Week 28

change from baseline, improvement

Secondary/registry result

Change From Baseline in Fasting Glucose

Time frame:Baseline, Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligrams per decilitre (mg/dL)95% CI
Tirzepatide 15 mg-51.4—
Semaglutide 1 mg-42.4—
Placebo-4.3—
Least Squares Mean Difference-38.195% CI-45.4 – -30.7p<0.001ANCOVA
Least Squares Mean Difference-47.195% CI-54.6 – -39.5p<0.001ANCOVA
Least Squares Mean Difference-9.095% CI-15.4 – -2.6p0.006ANCOVA
Secondary/registry result

Change From Baseline in Postmeal Glucose

Time frame:Baseline, Week 28

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Milligrams per decilitre*minute95% CI
Tirzepatide 15 mg-17414.0—
Semaglutide 1 mg14236.9—
Placebo459.2—
Least Squares Mean Difference-14696.195% CI-17045.0 – -12347.3p<0.001ANCOVA
Least Squares Mean Difference-17873.295% CI-20239.0 – -15507.4p<0.001ANCOVA
Least Squares Mean Difference-3177.195% CI-5194.3 – -1159.8p0.002ANCOVA
Secondary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), % of HbA1c95% CI
Tirzepatide 15 mg2.05—
Semaglutide 1 mg-1.64—
Placebo0.29—
Least Squares Mean Difference-1.9395% CI-2.18 – -1.67p<0.001Mixed Models Analysis
Least Squares Mean Difference-2.3395% CI-2.58 – -2.08p<0.001Mixed Models Analysis
Least Squares Mean Difference-0.4195% CI-0.63 – -0.19p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)

Time frame:Baseline and Week 28

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), pmol/min/m^295% CI
Tirzepatide 15 mg388.6—
Semaglutide 1 mg286.6—
Placebo7.4—
Least Squares Mean Difference279.1495% CI245.10 – 313.18p<0.001ANCOVA
Least Squares Mean Difference381.2395% CI339.29 – 423.17p<0.001ANCOVA
Least Squares Mean Difference102.0995% CI51.84 – 152.33p<0.001ANCOVA
Secondary/registry result

Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

Time frame:Baseline, Week 28

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), umol/min/kg [body weight]95% CI
Tirzepatide 15 mg19.2—
Semaglutide 1 mg10.7—
Placebo-0.6—
Least Squares Mean Difference11.395% CI4.9 – 17.7p<0.001ANCOVA
Least Squares Mean Difference19.895% CI13.4 – 26.1p<0.001ANCOVA
Least Squares Mean Difference8.595% CI3.0 – 14.0p0.003ANCOVA
Secondary/protocol endpoint

Change From Baseline in Fasting Glucose

Time frame:Baseline, Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Postmeal Glucose

Time frame:Baseline, Week 28

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)

Time frame:Baseline and Week 28

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

Time frame:Baseline, Week 28

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glucagon Concentration at Fasting

Time frame:Baseline and Week 28

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/registry result/low confidence

Change From Baseline in Food Intake During Ad Libitum Meal

Time frame:Baseline, Week 28

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilocalorie (kcal)95% CI
Tirzepatide 15 mg-348.4—
Semaglutide 1 mg-284.1—
Placebo-38.6—
Least Squares Mean Difference-245.595% CI-357.7 – -133.3p<0.001Mixed Models Analysis
Least Squares Mean Difference-309.895% CI-423.0 – -196.6p<0.001Mixed Models Analysis
Least Squares Mean Difference-64.395% CI-160.3 – 31.7p0.187Mixed Models Analysis

Other (unclassified)

4 endpoints
Secondary/registry result/low confidence

Change From Baseline in Glucagon Concentration at Fasting

Time frame:Baseline and Week 28

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), picomoles per litre (pmol/L)95% CI
Tirzepatide 15 mg-3.6—
Semaglutide 1 mg-2.8—
Placebo0.8—
Least Squares Mean Difference-3.695% CI-5.5 – -1.8p<0.001ANCOVA
Least Squares Mean Difference-4.595% CI-6.3 – -2.6p<0.001ANCOVA
Least Squares Mean Difference-0.895% CI-2.4 – 0.7p0.277ANCOVA
Secondary/registry result/low confidence

Change From Baseline in Glucagon Concentration at Postmeal

Time frame:Baseline and Week 28

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), (pmol/L)*min95% CI
Tirzepatide 15 mg-843.6—
Semaglutide 1 mg-502.0—
Placebo-205.9—
Slope-296.195% CI-584.8 – -7.5p0.044ANCOVA
Least Squares Mean Difference-637.795% CI-925.2 – -350.2p<0.001ANCOVA
Least Squares Mean Difference-341.695% CI-585.2 – -97.9p0.006ANCOVA
Secondary/protocol endpoint/low confidence

Change From Baseline in Glucagon Concentration at Postmeal

Time frame:Baseline and Week 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Food Intake During Ad Libitum Meal

Time frame:Baseline, Week 28

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.