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
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: TIRZEPATIDE
Current Sponsor code: LY3298176
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have been diagnosed with T2DM based on the World Health Organization classification or other locally applicable diagnostic standards. • Have been treated for at least 90 days prior to study entry - with once or twice daily dose of basal insulin, either o insulin NPH o insulin glargine (U100) o insulin glargine (U300) o insulin detemir (U100) o insulin degludec (U100), or o insulin degludec (U200), and - with or without oral glucose lowering medications in any combination up to 2 of the following: o stable daily dose of metformin =1500 mg/day and up to maximum approved dose per country specific approved label o SUs o DPP4is • Have an HbA1c =7.5% (58 mmol/mol) to =11% (97 mmol/mol), at study entry (determined by central laboratory) and an HbA1c =7.5% (58 mmol/mol) to =11% (97 mmol/mol), at pre-randomization, for those participants that need insulin glargine (U100) optimization determined by the central laboratory. • Are of stable weight (± 5%) 90 days or more prior to study entry 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. • Have a BMI =23 kg/m² and =45 kg/m² at study entry. • Are male or females at least 18 years of age or of an acceptable age to provide informed consent according to local regulations, whichever is older. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 591 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 591
Exclusion criteria
Exclusion criteria: • Have T1DM. • Had chronic or acute pancreatitis any time prior to study entry. • Have history of: - proliferative diabetic retinopathy, or - diabetic macular edema, or - nonproliferative diabetic retinopathy that requires acute treatment. • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to study entry. • Have a history of diabetic ketoacidosis or hyperosmolar state/coma during 6 months prior to study entry. • Have any of the following CV conditions within 2 months prior to study entry: - acute myocardial infarction - cerebrovascular accident (stroke), or - hospitalization due to congestive heart failure. • Have New York Heart Association Functional Classification III and IV congestive heart failure. • Have an estimated glomerular filtration rate <30 mL/min/1.73 m², calculated by Chronic Kidney Disease-Epidemiology as determined by central laboratory at study entry; for participants on metformin, have an estimated glomerular filtration rate <45 mL/min/1.73 m² (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label). • Have family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. • Female participants who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate noninferiority of tirzepatide (pooled cohort of 5 mg, 10 mg, and 15 mg) QW to insulin lispro (U100) TID, when added to insulin glargine (U100), with or without metformin, with respect to glycemic control (for HbA1c) at 52 weeks.;Secondary Objective: • To demonstrate superiority of tirzepatide (pooled cohort 5 mg, 10 mg, and 15 mg) QW to insulin lispro (U100) TID, when added to insulin glargine (U100), with or without metformin at 52 weeks (for HbA1c, body weight, % participants reaching HbA1c <7%); • To demonstrate noninferitority of tirzepatide (5 mg, 10 mg, and/or 15 mg) QW to insulin lispro (U100) TID, when added to insulin glargine (U100), with or without metformin at 52 weeks (for HbA1c); • To demonstrate superiority of tirzepatide (5 mg, 10 mg, and/or 15 mg) QW to insulin lispro (U100) TID, when added to insulin glargine (U100), with or without metformin at 52 weeks (for HbA1c, body weight);;Primary end point(s): • Mean change in HbA1c from baseline.;Timepoint(s) of evaluation of this end point: At 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change in body weight from baseline; • Proportion of participants with HbA1c target values of <7.0% (53 mmol/mol); • Mean change in HbA1c from baseline.;Timepoint(s) of evaluation of this end point: At 52 weeks, and/or at the end of the safety follow-up period. | — |
Countries
Argentina, Belgium, Brazil, Czech Republic, Germany, Greece, Hungary, Italy, Mexico, Romania, Russian Federation, Slovakia, Spain, Turkey, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed