Change From Baseline in Hemoglobin A1c (HbA1c)
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -2.37 | 0.066 |
| 10 mg Tirzepatide | -2.55 | 0.067 |
| 15 mg Tirzepatide | -2.82 | 0.066 |
| 0.75 mg Dulaglutide | -1.29 | 0.065 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name SURPASS J-mono
Japan
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
5 mg Tirzepatide
Participants received 5 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 52 weeks.
Experimental
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
Experimental
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
Active comparator
0.75 mg Dulaglutide
Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 52
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants With HbA1c of <7.0%
Time frame · Week 52
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Change From Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 52
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Time frame · Baseline, Week 52
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for with Baseline + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment (Type III sum of squares) as variables.
Change From Baseline in Body Weight
Time frame · Baseline, Week 52
Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline
Time frame · Week 52
Percentage of participants who achieve weight loss ≥5% from baseline.
Change From Baseline in Fasting Insulin
Time frame · Baseline, Week 52
Fasting Insulin is a test used to measure the amount of insulin in the body. LS mean was determined by MMRM model for post-baseline measures with log (Actual Measurement) = log (Baseline) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Change From Baseline in Fasting C-Peptide
Time frame · Baseline, Week 52
Fasting C-peptide is a test used to measure the amount of C-peptide in the body. A high level of C-peptide can mean that body is making too much insulin. LS mean was determined by MMRM model for post-baseline measures: log (Actual Measurement) = log (Baseline) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)
Time frame · Baseline, Week 52
HOMA-2B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in HOMA-2S (Insluin)
Time frame · Baseline, Week 52
HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia
Time frame · Baseline through Week 52
The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL) (\<3.0 mmol/L\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model for post-baseline comparisons between treatment and control group: number of episodes = baseline hypoglycemia incidence + baseline BMI Group (\<25 or \>=25 kg/m\^2) + washout of antidiabetic medication + baseline hemoglobin A1C (%) + treatment, with log (exposure in days/365.25) as an offset variable.
Number of Participants With Anti-Tirzepatide Antibodies
Time frame · Baseline through Week 52
Number of participants with anti-tirzepatide antibodies. A participant is treatment emergent (TE) anti-drug antibody (ADA) evaluable if there is at least one non-missing test result for tirzepatide ADA for each of the baseline period and the postbaseline period. All percentages are relative to the total number of TE ADA evaluable participants in each treatment group. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -2.37 | 0.066 |
| 10 mg Tirzepatide | -2.55 | 0.067 |
| 15 mg Tirzepatide | -2.82 | 0.066 |
| 0.75 mg Dulaglutide | -1.29 | 0.065 |
| Group | Value (percentage of participants) |
|---|---|
| 5 mg Tirzepatide | 93.67 |
| 10 mg Tirzepatide | 96.79 |
| 15 mg Tirzepatide | 99.37 |
| 0.75 mg Dulaglutide | 67.30 |
| Group | Value (milligrams per decilitre (mg/dL)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -57.9 | 1.73 |
| 10 mg Tirzepatide | -64.6 | 1.76 |
| 15 mg Tirzepatide | -67.6 | 1.75 |
| 0.75 mg Dulaglutide | -31.9 | 1.73 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -59.5 | 1.46 |
| 10 mg Tirzepatide | -64.2 | 1.50 |
| 15 mg Tirzepatide | -68.6 | 1.50 |
| 0.75 mg Dulaglutide | -42.2 | 1.48 |
| Group | Value (kilogram (kg)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -5.8 | 0.41 |
| 10 mg Tirzepatide | -8.5 | 0.42 |
| 15 mg Tirzepatide | -10.7 | 0.41 |
| 0.75 mg Dulaglutide | -0.5 | 0.41 |
| Group | Value (percentage of participants) |
|---|---|
| 5 mg Tirzepatide | 60.76 |
| 10 mg Tirzepatide | 82.05 |
| 15 mg Tirzepatide | 89.31 |
| 0.75 mg Dulaglutide | 10.69 |
| Group | Value (milliunits per litre (mU/L)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -1.07 | 0.374 |
| 10 mg Tirzepatide | -1.87 | 0.344 |
| 15 mg Tirzepatide | -2.00 | 0.335 |
| 0.75 mg Dulaglutide | 1.40 | 0.482 |
| Group | Value (micrograms per liter (ug/L)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -0.25 | 0.045 |
| 10 mg Tirzepatide | -0.39 | 0.042 |
| 15 mg Tirzepatide | -0.37 | 0.042 |
| 0.75 mg Dulaglutide | 0.01 | 0.052 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 5 mg TirzepatideParticipants received 5 mg tirzepatide administered SC once weekly for 52 weeks. | 0 / 159 | 8 / 159 | 131 / 159 |
| 10 mg TirzepatideParticipants received 10 mg tirzepatide administered SC once weekly for 52 weeks. | 0 / 158 | 10 / 158 | 121 / 158 |
| 15 mg TirzepatideParticipants received 15 mg tirzepatide administered SC once weekly for 52 weeks. | 0 / 160 | 7 / 160 | 134 / 160 |
| 0.75 mg DulaglutideParticipants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks. | 0 / 159 | 14 / 159 | 120 / 159 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
4 studies on this page
PubMed tag: none · 2025
Hamamoto et al. 2025Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 3
PMID 39951042PMC11926299DOI 10.1007/s13300-025-01704-zPUB-39951042
PubMed tag: none · 2024
Onishi et al. 2024Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 4
PMID 38310163PMC10942919DOI 10.1007/s13300-024-01534-5PUB-38310163
PubMed tag: none · 2023
Ishii et al. 2023Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 8
PMID 37843771PMC10597937DOI 10.1007/s13300-023-01485-3PUB-37843771
Indexing hint: Meta-analysis (pooled) · 2022
Sattar et al. 2022Nature medicinecited by 268
PMID 35210595PMC8938269DOI 10.1038/s41591-022-01707-4PUB-35210595
2 studies on this page
PubMed tag: none · 2025
Mimura et al. 2025Diabetes therapy : research, treatment and education of diabetes and related disorders
PMID 40711720PMC12399453DOI 10.1007/s13300-025-01775-yPUB-40711720
Indexing hint: Randomized controlled trial · 2022
Inagaki et al. 2022The lancet. Diabetes & endocrinologycited by 185
PMID 35914543DOI 10.1016/s2213-8587(22)00188-7PUB-35914543
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