Phase 3
Completed N=1,444
A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03882970 ↗Enrolled (actual)
1,444
Serious AEs
6.8%
Results posted
Jan 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) — -2.20; -2.37; -1.34 Percentage of HbA1c — p=<0.001
◆ Published Evidence
Established
66citations · ~66 / year
Tirzepatide and muscle composition changes in people with type 2 diabetes (SURPASS-3 MRI): a post-hoc analysis of a randomised, open-label, parallel-group, phase 3 trial.
Summary
The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.
Linked Publications (5)
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Tirzepatide and muscle composition changes in people with type 2 diabetes (SURPASS-3 MRI): a post-hoc analysis of a randomised, open-label, parallel-group, phase 3 trial.
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Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme.
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Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3.
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Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics.
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Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) |
-2.20; -2.37; -1.34 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c (5 mg) |
-1.93; -1.34 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-7.5; -10.7; -12.9; 2.3 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-48.2; -54.8; -59.2; -55.7 | 0.004 sig |
| SECONDARY Percentage of Participants Achieving an HbA1c Target Value of <7% |
82.44; 89.71; 92.63; 61.25 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-52.6; -59.7; -60.6; -48.0 | — |
| SECONDARY Percentage of Participants Who Achieved Weight Loss ≥5% |
66.01; 83.71; 87.82; 6.27 | <0.001 sig |
| SECONDARY Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score |
-1.4; -1.4; -1.6; -1.1; -1.1; -0.9 | 0.096 |
| SECONDARY Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia |
0.0137; 0.0108; 0.0275; 0.1020 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must:
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between ≥7.0% and ≤10.5%
- Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
- Be of stable weight (± 5%) for at least 3 months before screening
- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria
- Participants must not:
- Have type 1 diabetes mellitus
- Have had chronic or acute pancreatitis any time prior to study entry
- Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
- Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
- Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
- 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 any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
- Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Data sourced from ClinicalTrials.gov (NCT03882970) 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.