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

NCT03951753 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 17091I8F-MC-GPGT2018-003343-37
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

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, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Clamp Disposition Index (cDI)

  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 (ISR AUC0-120min) 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. Least squares (LS) mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).

  Baseline, Week 28

Secondary Outcomes (8)

• Change From Baseline in Fasting Glucose

  Baseline, Week 28

• Change From Baseline in Postmeal Glucose

  Baseline, Week 28

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Baseline, Week 28

• Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)

  Baseline and Week 28

• Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

  Baseline, Week 28

Study Arms (3)

Tirzepatide 15 mg

EXPERIMENTAL

Participants received 15 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.

Drug: Tirzepatide

Semaglutide 1 mg

ACTIVE COMPARATOR

Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants received Placebo administered SC once weekly for 28 weeks.

Drug: Placebo

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Tirzepatide 15 mg

Semaglutide DRUG

Administered SC

Semaglutide 1 mg

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have T2DM for at least 6 months
• Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
• Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Profil Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, 55116, Germany

Location

Related Publications (2)

• Heise T, DeVries JH, Urva S, Li J, Pratt EJ, Thomas MK, Mather KJ, Karanikas CA, Dunn J, Haupt A, Milicevic Z, Coskun T. Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes. Diabetes Care. 2023 May 1;46(5):998-1004. doi: 10.2337/dc22-1710.

  PMID: 36857477 DERIVED

• Heise T, Mari A, DeVries JH, Urva S, Li J, Pratt EJ, Coskun T, Thomas MK, Mather KJ, Haupt A, Milicevic Z. Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):418-429. doi: 10.1016/S2213-8587(22)00085-7. Epub 2022 Apr 22.

  PMID: 35468322 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tirzepatide; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: June 28, 2019
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)