Type 2 diabetes mellitus MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Tirzepatide
Product Code: LY3298176
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Tirzepatide
Other descriptive name: LY3298176
Concentration unit: m
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have been diagnosed with T2DM based on the World Health Organization classification or other locally applicable diagnostic standards [2] Have HbA1c =7.0% (=53 mmol/mol) to =10.5% (=91 mmol/mol), as determined by the central laboratory at Visit 1 [3] Are of stable weight (±5%) =3 months preceding Visit 1 and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight, other than the lifestyle and dietary measures for diabetes treatment [4] Have body mass index (BMI) =25 kg/m2 at Visit 1 [5] Have been on stable diabetes treatment with metformin =1500 mg/day during the 3 months prior to Visit 1 and between Visits 1 and 3 [6] Are 18 years old or of an acceptable age to provide informed consent according to local regulations, whichever is older Male patients - Male patients should be willing to use reliable contraceptive methods throughout the study and for at least 3 months after last injection Female patients: - Female patients not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation), congenital anomaly (that is, Mullerian agenesis), or menopause o Women with an intact uterus are deemed postmenopausal if they are at least 45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year OR have had at least 6 months and less than 12 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) and estradiol levels consistent with a postmenopausal state (FSH =40 mIU/mL and estradiol =65 years) no F.1.3.1 Number of subjects for this age range 421
Exclusion criteria
Exclusion criteria: [1] Have type 1 diabetes mellitus (T1DM) [2] Have a history of chronic or acute pancreatitis any time prior to study entry (Visit 1) [3] Have a history of any of the following: - proliferative diabetic retinopathy, OR - diabetic maculopathy, OR - nonproliferative diabetic retinopathy that requires acute treatment (a dilated fundoscopic examination performed by an ophthalmologist or optometrist between Visit 2 and Visit 3 is required to confirm eligibility) [4] Have a history of ketoacidosis or hyperosmolar state/coma [5] Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Visit 1 [6] Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone or plan to have during the course of the study: gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or chronically take drugs that directly affect GI motility [7] Have any of the following cardiovascular (CV) conditions within 2 months prior to Visit 1: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization due to congestive heart failure (CHF) [8] Have a history of New York Heart Association Functional Classification IV CHF [9] Have acute or chronic hepatitis, signs and symptoms of any liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at study entry. Patients with NAFLD are eligible to participate in this trial if their ALT level is =3.0 times the ULN for the reference range [10] Have an estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by Chronic Kidney Disease-Epidemiology as determined by central laboratory at Visit 1 [11] Have evidence of a significant, uncontrolled endocrine abnormality (for example, thyrotoxicosis or adrenal crises), in the opinion of the investigator [12] Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) [13] Have a serum calcitonin level of =35 ng/L, as determined by central laboratory at Visit 1 [14] Have known or suspected hypersensitivity to trial product(s) or related products 15] Have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis) that, in the opinion of the investigator, is likely to require concurrent treatment with systemic glucocorticoids in the next 12 months [16] Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant [17] Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years [18] Have any hematological condition that may interfere with HbA1c measurement (for example, hemolytic anemias, sickle cell disease) [19] Have been treated with any antihyperglycemic medication (other than metformin) within the 3 months prior to Visit 1. An exception is for the use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or electiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that tirzepatide 10 mg and/or 15 mg administered once weekly (QW) are noninferior to semaglutide 1 mg QW for glycemic control (mean change in HbA1c from baseline) at 40 weeks;Secondary Objective: - To demonstrate that tirzepatide 5 mg administered once weekly (QW) is noninferior to semaglutide 1 mg QW for glycemic control (mean change in HbA1c from baseline) at 40 weeks - To demonstrate that tirzepatide 5 mg, 10 mg, and/or 15 mg QW is superior to semaglutide 1 mg QW at 40 weeks for the following: - Mean change in body weight from baseline - Mean change in HbA1c from baseline - Proportion of patients with HbA1c target values of <7.0 % (53 mmol/mol) ;Primary end point(s): Mean change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: 40 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Mean change in HbA1c from baseline -Mean change in body weight from baseline - Proportion of patients with HbA1c target values of <7.0% (53 mmol/mol);Timepoint(s) of evaluation of this end point: 40 weeks | — |
Countries
Argentina, Australia, Brazil, Canada, Israel, Mexico, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed