Phase 3
Completed N=917
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Type 2 Diabetes
Source: ClinicalTrials.gov NCT04093752 ↗
Enrolled (actual)
917
Serious AEs
7.1%
Results posted
Jan 2023
Primary outcomePrimary: Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) — -2.44; -2.49; -0.95 Percentage of HbA1c
◆ Published Evidence
Established
94citations · ~31 / year
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.
Summary
The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.
Linked Publications (2)
-
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.
-
Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) |
-2.44; -2.49; -0.95 | — |
| SECONDARY Mean Change From Baseline in HbA1c (5 mg) |
-2.24; -0.95 | — |
| SECONDARY Mean Change From Baseline in Body Weight |
-5.0; -7.0; -7.2; 1.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an HbA1c Target Value of <7.0% |
75.44; 86.04; 84.38; 23.72 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an HbA1c Target Value of <5.7% |
14.91; 20.72; 27.68; 0.00 | 0.002 sig |
| SECONDARY Mean Change From Baseline in Fasting Serum Glucose |
-58.6; -66.2; -64.8; -46.2 | <0.001 sig |
| SECONDARY Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-77.0; -83.4; -84.6; -42.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Weight Loss ≥5% |
55.70; 71.62; 74.11; 5.58 | <0.001 sig |
| SECONDARY Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score |
-1.8; -2.1; -2.0; -1.3; -1.9; -1.9 | 0.007 sig |
| SECONDARY Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia |
0.0658; 0.0890; 0.0700; 0.0538 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04093752) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.