Phase 3
Completed N=636
A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes
Type 2 Diabetes
Source: ClinicalTrials.gov NCT03861052 ↗
Enrolled (actual)
636
Serious AEs
6.1%
Results posted
Apr 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -2.37; -2.55; -2.82; -1.29 percentage of HbA1c — p=<0.001
◆ Published Evidence
Highly cited
207citations · ~52 / year
Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial.
Summary
The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.
Linked Publications (5)
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Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial.
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Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial.
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Metabolic Abnormalities Following Tirzepatide Monotherapy in Japanese Patients with Type 2 Diabetes: A Phase 3 SURPASS J-mono Post Hoc Analysis.
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Insulin Sensitivity and Beta-Cell Function Following Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J-mono Analysis.
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Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-2.37; -2.55; -2.82; -1.29 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c of <7.0% |
93.67; 96.79; 99.37; 67.30 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-57.9; -64.6; -67.6; -31.9 | <0.001 sig |
| SECONDARY Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-59.5; -64.2; -68.6; -42.2 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-5.8; -8.5; -10.7; -0.5 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline |
60.76; 82.05; 89.31; 10.69 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Insulin |
-1.07; -1.87; -2.00; 1.40 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting C-Peptide |
-0.25; -0.39; -0.37; 0.01 | <0.001 sig |
| SECONDARY Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin) |
38.5; 43.0; 46.3; 22.4 | <0.001 sig |
| SECONDARY Change From Baseline in HOMA-2S (Insluin) |
14.5; 21.6; 25.7; -5.4 | <0.001 sig |
| SECONDARY Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia |
0; 0; 0.012; 0 | — |
| SECONDARY Number of Participants With Anti-Tirzepatide Antibodies |
97; 102; 123; 8 | — |
Eligibility Criteria
Inclusion Criteria
Participant must:
- Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.
- Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:
- for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.
- for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.
- Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
- Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive 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.
Exclusion Criteria
Participant 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 immediate or urgent 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 there ALT level is ≤3.0 the ULN for the reference range.
- 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.
Data sourced from ClinicalTrials.gov (NCT03861052) 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.