- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050553
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus
February 24, 2022 updated by: Eli Lilly and Company
A Randomized, Placebo-Controlled, Crossover Study to Investigate the Effect of Once-Weekly Tirzepatide on the Counter-Regulatory Response to Hypoglycemia in Patients With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Steiermark
-
Graz, Steiermark, Austria, 8036
- Universitätsklinikum Graz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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])
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC) in one of two study periods.
|
Administered SC
Other Names:
|
Placebo Comparator: Placebo
Placebo administered SC in one of two study periods.
|
Administered SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level
|
Change in Mean Glucagon Concentration During Induced Hypoglycemia from Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Insulin Concentrations from Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
Time Frame: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Change in Mean Insulin Concentrations from Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Change in Mean C-peptide Concentrations from Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
Time Frame: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Change in Mean C-peptide Concentrations from Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Time from Termination of Insulin Infusion at PG Concentration of 45 mg/dL to Reach Recovery PG Concentration (72 mg/dL)
Time Frame: Week 12 in each treatment period (treatment period = 12 weeks): 1 minute after reaching the nadir glucose level and when reaching normoglycemia (estimated as 30 mins)
|
Time from Termination of Insulin Infusion at PG Concentration of 45 mg/dL to Reach Recovery PG Concentration (72 mg/dL)
|
Week 12 in each treatment period (treatment period = 12 weeks): 1 minute after reaching the nadir glucose level and when reaching normoglycemia (estimated as 30 mins)
|
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)
Time Frame: Week 12 in each treatment period (treatment period = 12 weeks): 1 minute after reaching the nadir glucose level and when reaching normoglycemia (estimated as 30 mins)
|
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)
|
Week 12 in each treatment period (treatment period = 12 weeks): 1 minute after reaching the nadir glucose level and when reaching normoglycemia (estimated as 30 mins)
|
Mean Change in Blood Pressure from Induced Hypoglycemia Target PG Nadir Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
Time Frame: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Mean Change in Blood Pressure from Induced Hypoglycemia Target PG Nadir Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Mean Change in Heart Rate from Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
Time Frame: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Mean Change in Heart Rate from Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2020
Primary Completion (Actual)
January 25, 2022
Study Completion (Actual)
January 25, 2022
Study Registration Dates
First Submitted
August 7, 2019
First Submitted That Met QC Criteria
August 7, 2019
First Posted (Actual)
August 8, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2022
Last Update Submitted That Met QC Criteria
February 24, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17222 (Other Identifier: City of Hope Medical Center)
- I8F-MC-GPHG (Other Identifier: Eli Lilly and Company)
- 2019-001360-29 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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