A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Phase 4Active Not RecruitingNCT05433584

Eli Lilly and Company780 enrolled

Overview

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

780

Conditions

Type 2 Diabetes

Interventions

TirzepatideDRUG

Administered SC

Antihyperglycemic medicationDRUG

As prescribed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards. * Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory. * Have been on a stable treatment of metformin only at least 90 days preceding baseline * with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or * \<1500 mg/day in case of intolerance of full therapeutic dose. Exclusion Criteria: * Have type 1 diabetes mellitus * Have a history of chronic or acute pancreatitis any time prior to study entry * Have a history of * proliferative diabetic retinopathy * diabetic macular edema, or * no proliferative diabetic retinopathy requiring immediate or urgent treatment * Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry * myocardial infarction * percutaneous coronary revascularization procedure * carotid stenting or surgical revascularization * nontraumatic amputation * peripheral vascular procedure (e.g., stenting or surgical revascularization) * cerebrovascular accident (stroke), or congestive heart failure * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies * Have an estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening. * Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening. * Exception: use of insulin for gestational diabetes or short-term use (\<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

Locations (90)

Outcomes

Primary Outcomes

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame: Baseline, Week 104

Secondary Outcomes

Change from Baseline in HbA1c

Time frame: Baseline, Week 208

Change from Baseline in Weight

Time frame: Baseline, Week 104

Change from Baseline in Weight

Time frame: Baseline, Week 208

Change from Baseline in Waist Circumference

Time frame: Baseline, Week 104

Change from Baseline in Waist Circumference

Time frame: Baseline, Week 208

Change from Baseline in Fasting Serum Glucose (FSG)

Time frame: Baseline, Week 104

Change from Baseline in FSG

Time frame: Baseline, Week 208

Change from Baseline in Lipids

Time frame: Baseline, Week 104

Change from Baseline in Lipids

Time frame: Baseline, Week 208

Percentage of Participants Achieving HbA1c <7.0%

Time frame: Week 104

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame: Week 104

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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Los Angeles, California, United States

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Montclair, California, United States

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North Hollywood, California, United States

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Panorama City, California, United States

Western University of Health Sciences

Pomona, California, United States

...and 80 more locations

Percentage of Participants Achieving HbA1c <5.7%

Time frame: Week 104

Percentage of Participants Achieving HbA1c <7.0%

Time frame: Week 208

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame: Week 208

Percentage of Participants Achieving HbA1c <5.7%

Time frame: Week 208

Change from Baseline in Weight loss of ≥5%,

Time frame: Baseline, Week 104

Change from Baseline in Weight loss of ≥10%

Time frame: Baseline, Week 104

Change from Baseline in Weight loss of ≥15%

Time frame: Baseline, Week 104

Change from Baseline in Weight loss of ≥5%

Time frame: Baseline, Week 208

Change from Baseline in Weight loss of ≥10%

Time frame: Baseline, Week 208

Change from Baseline in Weight loss of ≥15%

Time frame: Baseline, Week 208

A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia

A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) \<54 milligram/deciliter (mg/dL) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia

Time frame: Week 104

A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia

A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG \<54 mg/dL (\<3.0 mmol/L) and/or severe hypoglycemia

Time frame: Week 208

Change from Baseline in β-cell Glucose Sensitivity

β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)

Time frame: Baseline, Week 104

Change from Baseline in β-cell glucose sensitivity

Change from baseline in β-cell glucose sensitivity assessed by OGTT

Time frame: Baseline, Week 208

Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration

Insulin Secretion Rate assessed by OGTT

Time frame: Baseline, Week 104

Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration

Insulin Secretion Rate assessed by OGTT

Time frame: Baseline, Week 208

Change from Baseline in Postprandial Insulin Sensitivity Indices

Postprandial Insulin Sensitivity Indices assessed by OGTT

Time frame: Baseline, Week 104

Change from Baseline in Postprandial Insulin Sensitivity Indices

Postprandial Insulin Sensitivity Indices assessed by OGTT

Time frame: Baseline, Week 208

Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]

Fasting and Post-challenge Glucose \[total and incremental AUC(₀-₂₄₀min)\] assessed by OGTT

Time frame: Baseline through Week 104

Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]

Fasting and Post-challenge Glucose \[total and incremental AUC(₀-₂₄₀min)\] assessed by OGTT

Time frame: Baseline through Week 208

Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain

Time frame: Baseline, Week 104

Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain

Time frame: Baseline, Week 208