Phase 2
Completed N=111
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03311724 ↗Enrolled (actual)
111
Serious AEs
0.9%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Haemoglobin A1c (HbA1c) — 0.2; -1.7; -2.0; -1.8 Percentage of HbA1C — p=<0.001
Summary
The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Haemoglobin A1c (HbA1c) |
0.2; -1.7; -2.0; -1.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving HbA1c Target of <7.0% |
10; 74.1; 87; 84.6 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) |
-12.3; -60.7; -70.2; -74.2 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-0.5; -5.3; -5.5; -5.7 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-2.5; -4.8; -4.9; -4.9 | 0.075 |
| SECONDARY Number of Participants With Anti Drug Antibodies |
0; 10; 8; 4 | — |
| SECONDARY Number of Episodes of Total Hypoglycemia Episodes |
0; 0; 0; 1 | — |
| SECONDARY Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide |
508; 704; 630 | — |
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017).
- Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
- If on metformin, have been treated with stable doses of metformin for at least 3 months.
- Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.
Exclusion Criteria
- Have type 1 diabetes (T1D).
- Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.
- Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
- Have had chronic or acute pancreatitis any time prior to study entry.
- Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
- Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
- Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
Data sourced from ClinicalTrials.gov (NCT03311724). 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.