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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT03951753 (opens ClinicalTrials.gov in a new tab)Other id17091Other idI8F-MC-GPGTOther id2018-003343-37Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
117 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
28 Jun 2019
Primary completion
8 Apr 2021
Completion
8 Apr 2021
First posted
15 May 2019
Last update posted
20 Mar 2023
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 1

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

    NCT03951753

    28 Jun 2019 to 8 Apr 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • SemaglutideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Tirzepatide 15 mg

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

  • Active comparator

    Semaglutide 1 mg

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

  • Placebo comparator

    Placebo

    Participants received Placebo administered SC once weekly for 28 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Total Clamp Disposition Index (cDI)

    Time frame · Baseline, Week 28

    Registry description

    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).

Secondary outcomes(8)

  1. Change From Baseline in Fasting Glucose

    Time frame · Baseline, Week 28

    Registry description

    Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. Fasting glucose was measured prior to standardized mixed-meal tolerance tests (sMMTT). LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

  2. Change From Baseline in Postmeal Glucose

    Time frame · Baseline, Week 28

    Registry description

    Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT was evaluated. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares) and ANOVA model for baseline measures: Variable = Treatment (Type III sum of squares).

  3. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 28

    Registry description

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by mixed model repeated measures; (MMRM) model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline and Week 28

    Registry description

    Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) will be determined from C-peptide concentrations using the deconvolution technique. LS mean was determined by ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).

  5. Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

    Time frame · Baseline, Week 28

    Registry description

    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. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

  6. Change From Baseline in Glucagon Concentration at Fasting

    Time frame · Baseline and Week 28

    Registry description

    Glucagon concentration was measured prior to sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

  7. Change From Baseline in Glucagon Concentration at Postmeal

    Time frame · Baseline and Week 28

    Registry description

    Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

  8. Change From Baseline in Food Intake During Ad Libitum Meal

    Time frame · Baseline, Week 28

    Registry description

    Ad libitum meal served buffet-style. Food intake was recorded during a 45 minute period. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Total Clamp Disposition Index (cDI)

GroupValue (pmol*m-2*L*min-2*kg-1)Spread
Tirzepatide 15 mg1.90.16
Semaglutide 1 mg1.10.10
Placebo0.00.03
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Fasting Glucose

GroupValue (milligrams per decilitre (mg/dL))Spread
Tirzepatide 15 mg-51.42.30
Semaglutide 1 mg-42.42.22
Placebo-4.32.98
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Postmeal Glucose

GroupValue (Milligrams per decilitre*minute)Spread
Tirzepatide 15 mg-17414.0726.02
Semaglutide 1 mg14236.9709.53
Placebo459.2947.50
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (% of HbA1c)Spread
Tirzepatide 15 mg2.050.079
Semaglutide 1 mg-1.640.078
Placebo0.290.101
Secondary outcomeLeast squares mean· Baseline and Week 28

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

GroupValue (pmol/min/m^2)Spread
Tirzepatide 15 mg388.620.17
Semaglutide 1 mg286.615.82
Placebo7.47.15
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

GroupValue (umol/min/kg [body weight])Spread
Tirzepatide 15 mg19.21.93
Semaglutide 1 mg10.71.99
Placebo-0.62.53
Secondary outcomeLeast squares mean· Baseline and Week 28

Change From Baseline in Glucagon Concentration at Fasting

GroupValue (picomoles per litre (pmol/L))Spread
Tirzepatide 15 mg-3.60.55
Semaglutide 1 mg-2.80.55
Placebo0.80.75
Secondary outcomeLeast squares mean· Baseline and Week 28

Change From Baseline in Glucagon Concentration at Postmeal

GroupValue ((pmol/L)*min)Spread
Tirzepatide 15 mg-843.686.26
Semaglutide 1 mg-502.087.33
Placebo-205.9116.31

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received Placebo administered SC once weekly for 28 weeks.0 / 282 / 2818 / 28
Semaglutide 1 mgParticipants received 1 mg Semaglutide administered SC once weekly for 28 weeks.0 / 440 / 4443 / 44
Tirzepatide 15 mgParticipants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.0 / 451 / 4541 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

9 results

Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes.

Heise et al. 2023Diabetes carecited by 164

PMID 36857477PMC10154650DOI 10.2337/dc22-1710PUB-36857477

Rights unknown9 results
Source linkSee results (9)

Indexing hint: Randomized controlled trial · 2022

12 results

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.

Heise et al. 2022The lancet. Diabetes & endocrinologycited by 214

PMID 35468322DOI 10.1016/s2213-8587(22)00085-7PUB-35468322

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 74 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 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

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