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A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

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: NCT03951753
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : May 15, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 38 weeks, including a 28-week treatment period.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Tirzepatide on α and β Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : March 16, 2021
Estimated Study Completion Date : March 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Active Comparator: Semaglutide
Semaglutide administered SC
Drug: Semaglutide
Administered SC

Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Total Clamp Disposition Index (cDI) [ Time Frame: Baseline, Week 28 ]
    cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study.


Secondary Outcome Measures :
  1. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 28 ]
    Measured prior to standardized mixed-meal tolerance tests (sMMTT)

  2. Change from Baseline in Postmeal Glucose [ Time Frame: Baseline, Week 28 ]
    Measured during sMMTT

  3. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 28 ]
    Change from Baseline in HbA1c

  4. Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) [ Time Frame: Baseline and Week 28 ]
    ISR0-120 will be determined from C-peptide concentrations using the deconvolution technique

  5. Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value [ Time Frame: Baseline, Week 28 ]
    Hyperinsulinemic euglycemic clamp M-value is calculated from glucose infusion rate (GIR) over the last 30 minutes, corresponding to steady-state (+150 to +180 minutes), corrected for urine loss and space

  6. Glucagon Concentration at Fasting [ Time Frame: Baseline and Week 28 ]
    Measured prior to sMMTT

  7. Glucagon Concentration at Postmeal [ Time Frame: Baseline and Week 28 ]
    Incremental AUC from time zero to 240 minutes after start of the meal [AUC0-240min]) during sMMTT

  8. Change from Baseline in Food Intake During Ad Libitum Meal [ Time Frame: Baseline, Week 28 ]
    Ad libitum meal served buffet-style. Food intake will be recorded during a 45 minute period. The total amount of calories as well as the caloric breakdown (carbohydrates, protein, and fats) will be calculated from the respective nutritional information of the food items.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have T2DM for at least 6 months
  • Treated with diet and exercise and stable dose(s) of metformin, with or without dipeptidyl peptidase IV (DPP-IV) inhibitors, 3 months prior to study entry
  • Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin; or ≥6.5% and ≤9.5% if on metformin in combination with DPP-IV inhibitors
  • Have a body mass index (BMI) between 25 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 (<1.5 years) ophthalmologic examination
  • Impaired renal estimated glomerular filtration rate (eGFR) <45 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 or current cardiovascular, respiratory, hepatic, renal, 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

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): NCT03951753


Locations
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Germany
Profil Institut für Stoffwechselforschung
Neuss, Nordrhein-Westfalen, Germany, 41460
Profil Mainz GmbH & Co. KG
Mainz, Rheinland-Pfalz, Germany, 55116
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: NCT03951753    
Other Study ID Numbers: 17091
I8F-MC-GPGT ( Other Identifier: Eli Lilly and Company )
2018-003343-37 ( EudraCT Number )
First Posted: May 15, 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases