Phase 1
Completed N=42
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04050553 ↗Enrolled (actual)
42
Serious AEs
5.3%
Results posted
May 2024
Primary outcomePrimary: Change in Mean Glucagon Concentration During Induced Hypoglycemia From Target Plasma Glucose (PG) Concentration of 100 Milligrams Per Deciliter (mg/dL) to a Nadir Target of 45 mg/dL — 18.55; 18.07 picomole per liter (pmol/L) — p=0.7556
Summary
The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes. It will last about 42 weeks for each participant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Glucagon Concentration During Induced Hypoglycemia From Target Plasma Glucose (PG) Concentration of 100 Milligrams Per Deciliter (mg/dL) to a Nadir Target of 45 mg/dL |
18.55; 18.07 | 0.7556 |
| SECONDARY Change in Mean Insulin Concentrations From Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL |
-1053.31; -1228.08 | 0.0043 sig |
| SECONDARY Change in Mean C-peptide Concentrations From Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL |
-177.69; -665.99 | <0.0001 sig |
| SECONDARY Time From Termination of Insulin Infusion at PG Concentration of 45 mg/dL to Reach Recovery PG Concentration (72 mg/dL) |
43.34; 47.73 | 0.0023 sig |
| SECONDARY Hypoglycemia Symptoms Score From Induced Hypoglycemia at Target PG Concentrations of 100 mg/dL, 63 mg/dL, 45 mg/dL and Recovery (PG Concentration 72 mg/dL) |
1.19; 1.13; 1.35; 1.17; 1.68; 1.49 | 0.0505 |
| SECONDARY Mean Change in Blood Pressure From Induced Hypoglycemia Target PG Nadir Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL |
-5.01; -5.51; -9.84; -7.88 | 0.8298 |
| SECONDARY Mean Change in Heart Rate From Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL |
5.56; 4.67 | 0.5776 |
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes mellitus (T2DM) for at least 1 year
- Treated with diet and exercise and stable dose(s) of metformin 3 months prior to study entry with or without 1 additional oral antidiabetic medication (OAM) other than metformin.
- Have a hemoglobin A1c (HbA1c) value at screening of ≥6.5% and ≤9.0 % if on metformin only.
- Have a HbA1c value at screening of ≥6.0% and ≤8.5 %, if on metformin and 1 more allowed OAM.
- Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m²) inclusive, at screening
- Are of stable weight (±5%) >3 months prior to screening
Exclusion Criteria
- Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (<6 months) ophthalmologic examination
- Impaired renal estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
- Have had acute myocardial infarction, congestive heart failure New York Heart Association Class III or IV, history of or suspected ischemic heart disease, and/or cerebrovascular accident (stroke [including transient ischemic attack])
Data sourced from ClinicalTrials.gov (NCT04050553). 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.