Type 2 diabetes mellitus MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria • Have been diagnosed with Type 2 Diabetes • Have a stable body weight for the 3 months prior to randomization • Male contraception use should be highly effective/effective methods of contraception • Women not of childbearing potential (WNOCBP) may participate in this trial • Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1. 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 296 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: Exclusion Criteria • Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma • Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention • Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms • Have acute or chronic pancreatitis • Have obesity induced other endocrine disorders (Cushing’s syndrome or Prader - Willi syndrome • Have gastric emptying abnormality or chronically take medications impacting GI motility • Have poorly controlled hypertension • Have the following heart conditions: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure • Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD) • Have HIV, or Hepatitis B or Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that at least one dose level of QD oral doses of LY3502970 is superior in change from baseline for HbA1c relative to placebo at Week 26, in participants with T2DM inadequately controlled with diet and exercise alone or treated with a stable dose of metformin.;Secondary Objective: - To compare the effect of QD LY3502970 versus placebo and versus dulaglutide on glucose control at Week 26 - To assess safety and tolerability of LY3502970 - To assess the PK of LY3502970 and potential participant factors that may influence its PK;Primary end point(s): Difference between LY3502970 and placebo in change from baseline in HbA1c at Week 26;Timepoint(s) of evaluation of this end point: Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difference between LY3502970 and dulaglutide in change from baseline in HbA1c at Week 26 - Percentage of participants with HbA1c =6.5% and of <7.0% at Week 26 - Change from baseline in fasting blood glucose at 26 weeks - Change from baseline in body weight at Week 26 - Percent change in body weight from baseline at Week 26 - Percentage of participants with =5%, =10% body weight loss from baseline at Week 26 - Adverse events overall - Adverse events of special interest - Laboratory parameters - Electrocardiogram - Vital signs - Population PK Parameters;Timepoint(s) of evaluation of this end point: Week 26 | — |
Countries
Hungary, Poland, Slovakia, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed