What SURPASS-6 measured first
| Pooled 5 mg/10 mg/15 mg Tirzepatiden=708 | Insulin Lispron=692 |
|---|---|
| -2.26(0.048) | -1.16(0.049) |
A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) (Percentage of HbA1c), Baseline, Week 52. Pooled 5 mg/10 mg/15 mg Tirzepatide: -2.26; Insulin Lispro: -1.16.
As posted on ClinicalTrials.gov (NCT04537923), updated at source Nov 2, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Pooled 5 mg/10 mg/15 mg Tirzepatiden=708 | Insulin Lispron=692 |
|---|---|
| -2.26(0.048) | -1.16(0.049) |
Percent of participants affected, Baseline up to week 56. The most common events the registry lists.
| Event | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide | Insulin Lispro |
|---|---|---|---|---|
| Any serious event | 8.2% | 6.7% | 7.2% | 11.4% |
| Nausea | 13.6% | 20.6% | 25.8% | 1.1% |
| Decreased appetite | 8.2% | 11.8% | 16.9% | 0.1% |
| Diarrhoea | 11.9% | 15.1% | 11% | 2.4% |
| Vomiting | 4.5% | 8.8% | 12.7% | 0.6% |
| Covid-19 | 11.5% | 8% | 8.9% | 10.2% |
| Dyspepsia | 6.2% | 11.3% | 11.4% | 0.6% |
| Constipation | 2.5% | 3.4% | 5.9% | 0.6% |
| 5 mg Tirzepatiden=241 | 10 mg Tirzepatiden=234 | 15 mg Tirzepatiden=233 | Insulin Lispron=692 |
|---|---|---|---|
| -2.05(0.082) | -2.27(0.083) | -2.46(0.084) | -1.16(0.049) |
| 5 mg Tirzepatiden=242 | 10 mg Tirzepatiden=238 | 15 mg Tirzepatiden=236 | Insulin Lispron=708 |
|---|---|---|---|
| 61.04 | 75.64 | 79.86 | 36.69 |
| 5 mg Tirzepatiden=241 | 10 mg Tirzepatiden=234 | 15 mg Tirzepatiden=233 | Insulin Lispron=694 |
|---|---|---|---|
| -6.9(0.37) | -9.9(0.37) | -12.0(0.38) | 3.8(0.22) |
| 5 mg Tirzepatiden=241 | 10 mg Tirzepatiden=235 | 15 mg Tirzepatiden=233 | Insulin Lispron=694 |
|---|---|---|---|
| -33.2(3.28) | -43.0(3.32) | -41.6(3.42) | -10.0(1.99) |
| 5 mg Tirzepatiden=219 | 10 mg Tirzepatiden=210 | 15 mg Tirzepatiden=204 | Insulin Lispron=574 |
|---|---|---|---|
| -56.7(1.80) | -61.5(1.85) | 67.6(1.86) | -55.8(1.13) |
| 5 mg Tirzepatiden=241 | 10 mg Tirzepatiden=234 | 15 mg Tirzepatiden=233 | Insulin Lispron=692 |
|---|---|---|---|
| 52.70 | 70.05 | 75.12 | 13.41 |
| 5 mg Tirzepatiden=242 | 10 mg Tirzepatiden=238 | 15 mg Tirzepatiden=236 | Insulin Lispron=708 |
|---|---|---|---|
| 64.19 | 79.21 | 83.15 | 6.34 |
| 5 mg Tirzepatiden=222 | 10 mg Tirzepatiden=217 | 15 mg Tirzepatiden=199 | Insulin Lispron=599 |
|---|---|---|---|
| 1.0(0.46) | 1.7(0.46) | 1.7(0.48) | -0.6(0.28) |
| 5 mg Tirzepatiden=222 | 10 mg Tirzepatiden=217 | 15 mg Tirzepatiden=199 | Insulin Lispron=599 |
|---|---|---|---|
| 0.3(0.59) | 1.5(0.59) | 0.7(0.62) | -1.3(0.36) |
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.
Inclusion Criteria: * Have been diagnosed with type 2 diabetes mellitus (T2DM) * Have HbA1c between ≥7.5% and ≤11% * Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors * Be of stable weight (± 5%) for at least 90 days * Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening Exclusion Criteria * Have type 1 diabetes mellitus * Have had chronic or acute pancreatitis any time prior to study entry * Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment * Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility * Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months * Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * Have been taking weight loss drugs, including over-the-counter medications during the last 3 months * Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.