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A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050553
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : August 8, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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 38 weeks for each participant.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypoglycemia Drug: Tirzepatide Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : May 24, 2021
Estimated Study Completion Date : May 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC) in one of two study periods.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Placebo Comparator: Placebo
Placebo administered SC in one of two study periods.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Mean Insulin Concentrations from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL) [ Time Frame: Week 12 in each study period: 30 minutes after reaching the nadir glucose level and when reaching normoglycemia ]
    Change in Mean Insulin Concentrations from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL)

  2. 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 study period: 30 minutes after reaching the nadir glucose level and when reaching normoglycemia ]
    Time from Termination of Insulin Infusion at PG Concentration of 45 mg/dL to Reach Recovery PG Concentration (72 mg/dL)

  3. Change in Hypoglycemia Symptoms Score from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL) [ Time Frame: Week 12 in each study period: 30 minutes after reaching the nadir glucose level and when reaching normoglycemia ]
    Change in Hypoglycemia Symptoms Score from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL)

  4. Mean Change in Blood Pressure from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL) [ Time Frame: Week 12 in each study period: 30 minutes after reaching the nadir glucose level and when reaching normoglycemia ]
    Mean Change in Blood Pressure from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL)

  5. Mean Change in Heart Rate from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL) [ Time Frame: Week 12 in each study period: 30 minutes after reaching the nadir glucose level and when reaching normoglycemia) ]
    Mean Change in Heart Rate from Induced Hypoglycemia Target PG Nadir Concentration of 45 mg/dL to Recovery (PG Concentration 72 mg/dL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Have a hemoglobin A1c (HbA1c) value at screening of ≥6.5% and ≤9.0 %
  • Have a body mass index (BMI) between 25 and 40 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])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050553


Locations
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Austria
Universitätsklinikum Graz
Graz, Steiermark, Austria, 8036
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04050553    
Other Study ID Numbers: 17222
I8F-MC-GPHG ( Other Identifier: Eli Lilly and Company )
2019-001360-29 ( EudraCT Number )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases