Phase 3
Completed N=443
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03861039 ↗Enrolled (actual)
443
Serious AEs
5.4%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 1; 1 Participants
◆ Published Evidence
Highly cited
121citations · ~30 / year
Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial.
Summary
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
Linked Publications (2)
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Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial.
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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 Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 1; 1 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-2.57; -2.98; -3.02 | — |
| SECONDARY Percentage of Participants Who Achieve HbA1c <7% |
92.57; 97.95; 96.55 | — |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-58.6; -71.2; -74.4 | — |
| SECONDARY Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-80.0; -94.1; -96.3 | — |
| SECONDARY Change From Baseline in Body Weight |
-3.8; -7.5; -10.2 | — |
| SECONDARY Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline |
43.92; 70.55; 84.14 | — |
| SECONDARY Change From Baseline in Fasting Insulin |
6.2; -4.8; -7.7 | — |
| SECONDARY Change From Baseline in Fasting C-Peptide |
-0.12; -0.28; -0.34 | — |
| SECONDARY Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin) |
39.7; 44.9; 49.2 | — |
| SECONDARY Change From Baseline in HOMA-2S (Insulin) |
-0.1; 16.7; 24.1 | — |
| SECONDARY Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy |
1; 1; 3 | — |
| SECONDARY Number of Participants With Anti-Tirzepatide Antibodies |
87; 82; 88 | — |
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 ≥7.0% to 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 (NCT03861039) 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.