GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

917

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7.5-11%

Primary endpoint

•HbA1c, change

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 IDNCT04093752

Org study ID17210

Secondary IDI8F-MC-GPHOEli Lilly and Company

Timeline

Milestones

Study first posted2019-09-18actual

Study start2019-12-09actual

Primary completion2021-11-01actual

Study completion2021-11-24actual

Last update posted2023-01-06actual

Results first posted2023-01-06actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus

•Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months

•Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use [≤14 consecutive days] for acute conditions)

•HbA1c ≥7.5% to ≤11.0% at screening

•Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment

•Body mass Index (BMI) ≥23 kilograms per meter squared

Exclusion criteria

•Type 1 diabetes mellitus

•Have history of chronic or acute pancreatitis

•Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment

•Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months

•Have a history of ketoacidosis or hyperosmolar state/coma

•Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility

•Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months

•Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

•Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months

Endpoints (20)

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

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
5 mg Tirzepatide	-5.0	—
10 mg Tirzepatide	-7.0	—
15 mg Tirzepatide	-7.2	—
Insulin Glargine	1.5	—

LS Mean Difference-6.595% CI-7.4 – -5.6p<0.001Mixed Models Analysis

LS Mean Difference-8.595% CI-9.5 – -7.6p<0.001Mixed Models Analysis

LS Mean Difference-8.795% CI-9.6 – -7.7p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieved Weight Loss ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
5 mg Tirzepatide	55.70	—
10 mg Tirzepatide	71.62	—
15 mg Tirzepatide	74.11	—
Insulin Glargine	5.58	—

Odds Ratio (OR)21.8995% CI11.63 – 41.20p<0.001Regression, Logistic

Odds Ratio (OR)43.7995% CI22.96 – 83.50p<0.001Regression, Logistic

Odds Ratio (OR)48.4195% CI25.34 – 92.49p<0.001Regression, Logistic

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
10 mg Tirzepatide	-2.44	—
15 mg Tirzepatide	-2.49	—
Insulin Glargine	-0.95	—

LS Mean Difference-1.4995% CI-1.69 – -1.29

LS Mean Difference-1.5495% CI-1.74 – -1.34

Primary/protocol endpoint

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Mean Change From Baseline in HbA1c (5 mg)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
5 mg Tirzepatide	-2.24	—
Insulin Glargine	-0.95	—

LS Mean Difference-1.2995% CI-1.49 – -1.09

Secondary/registry result

Percentage of Participants Achieving an HbA1c Target Value of <7.0%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
5 mg Tirzepatide	75.44	—
10 mg Tirzepatide	86.04	—
15 mg Tirzepatide	84.38	—
Insulin Glargine	23.72	—

Odds Ratio (OR)14.5495% CI8.94 – 23.64p<0.001Regression, Logistic

Odds Ratio (OR)28.7695% CI16.72 – 49.49p<0.001Regression, Logistic

Odds Ratio (OR)25.2795% CI14.88 – 42.95p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Achieving an HbA1c Target Value of <5.7%

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
5 mg Tirzepatide	14.91	—
10 mg Tirzepatide	20.72	—
15 mg Tirzepatide	27.68	—
Insulin Glargine	0.00	—

Odds Ratio (OR)82.5495% CI5.13 – 1327.81p0.002Regression, Logistic

Odds Ratio (OR)124.7695% CI7.79 – 1997.01p<0.001Regression, Logistic

Odds Ratio (OR)184.9095% CI11.59 – 2950.73p<0.001Regression, Logistic

Secondary/registry result

Mean Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
5 mg Tirzepatide	-58.6	—
10 mg Tirzepatide	-66.2	—
15 mg Tirzepatide	-64.8	—
Insulin Glargine	-46.2	—

LS Mean Difference-12.395% CI-18.3 – -6.3p<0.001Mixed Models Analysis

LS Mean Difference-20.095% CI-26.1 – -13.9p<0.001Mixed Models Analysis

LS Mean Difference-18.695% CI-24.6 – -12.5p<0.001Mixed Models Analysis

Secondary/registry result

Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values

Time frame:Baseline, Week 40

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
5 mg Tirzepatide	-77.0	—
10 mg Tirzepatide	-83.4	—
15 mg Tirzepatide	-84.6	—
Insulin Glargine	-42.8	—

LS Mean Difference-34.295% CI-40.1 – -28.3p<0.001Mixed Models Analysis

LS Mean Difference-40.695% CI-46.7 – -34.6p<0.001Mixed Models Analysis

LS Mean Difference-41.895% CI-47.9 – -35.8p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Mean Change From Baseline in HbA1c (5 mg)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving an HbA1c Target Value of <7.0%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving an HbA1c Target Value of <5.7%

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values

Time frame:Baseline, Week 40

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/registry result

Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score

Time frame:Baseline, Week 40

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	95% CI
5 mg TirzepatideHyperglycemia	-1.8	—
Hypoglycemia	-1.9	—
Treatment Satisfaction Score	16.0	—
10 mg TirzepatideHyperglycemia	-2.1	—
Hypoglycemia	-1.9	—
Treatment Satisfaction Score	15.8	—
15 mg TirzepatideHyperglycemia	-2.0	—
Hypoglycemia	-2.0	—
Treatment Satisfaction Score	15.9	—
Insulin GlargineHyperglycemia	-1.3	—
Hypoglycemia	-1.8	—
Treatment Satisfaction Score	14.2	—

LS Mean Difference-0.4795% CI-0.81 – -0.13p0.007ANCOVA

Hyperglycemia

LS Mean Difference-0.7795% CI-1.11 – -0.43p<0.001ANCOVA

Hyperglycemia

LS Mean Difference-0.7195% CI-1.05 – -0.36p<0.001ANCOVA

Hyperglycemia

LS Mean Difference-0.1495% CI-0.46 – 0.18p0.384ANCOVA

Hypoglycemia

LS Mean Difference-0.1795% CI-0.49 – 0.16p0.307ANCOVA

Hypoglycemia

LS Mean Difference-0.2295% CI-0.55 – 0.11p0.184ANCOVA

Hypoglycemia

LS Mean Difference1.8195% CI1.03 – 2.59p<0.001ANCOVA

Treatment Satisfaction Score

LS Mean Difference1.6395% CI0.84 – 2.41p<0.001ANCOVA

Treatment Satisfaction Score

LS Mean Difference1.6895% CI0.89 – 2.47p<0.001ANCOVA

Treatment Satisfaction Score

Secondary/protocol endpoint

Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score

Time frame:Baseline, Week 40

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia

Time frame:Baseline through end of safety follow-up (Up To Week 44)

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (mean), Episodes/participant/365.25 days	95% CI
5 mg Tirzepatide	0.0658	—
10 mg Tirzepatide	0.0890	—
15 mg Tirzepatide	0.0700	—
Insulin Glargine	0.0538	—

Secondary/protocol endpoint

Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia

Time frame:Baseline through end of safety follow-up (Up To Week 44)

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Publications (4)

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

Clinical benefits and cost saving of achieving composite treatment targets for type 2 diabetes - A modeling study.
Journal of medical economics2026 Dec (month)PMID41504525doi:10.1080/13696998.2025.2604454via pubmed nct search
Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups.
Diabetes therapy : research, treatment and education of diabetes and related disorders2024 May (month)PMID38494574doi:10.1007/s13300-024-01561-2via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS-AP-Combo.
Diabetes, obesity & metabolism2024 Apr (month)PMID38302718doi:10.1111/dom.15446via pubmed nct search
Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial.
Nature medicine2023 Jun (month)PMID37231074doi:10.1038/s41591-023-02344-1via clinicaltrials gov reference derived + pubmed nct search

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.