Type 2 Diabetes
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants diagnosed with type 2 diabetes mellitus, based on the World Health Organaization classification. Have been treated for at least 90 days prior to screening with. a)Basal Insulin in combination with at least 1 prandial injection of bolus insulin b)Premixed analog or human insulin regimens with any basal or bolus insulin combination injected at least twice daily patiens may be treated with up to 3 of the following OAMs in accordance with local regulations, Metformin, DPP-4 inhibitor, SGLT2 inhibitor, Sulfonylurea, Meglitinide, Alphaglucoside inhibitor. Have an HBA1c value >=7.0 and <=10.0% , according to the central laboratory at screening. Participants who have a body mass index (BMI) of <=45.0 kilograms per meter squared(kg/m^2)
Exclusion criteria
Exclusion criteria: -Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults. -Have hypoglycemia unawareness as judged by the investigator. -Have had any episode of severe hypoglycemia within the 6 months prior to screening. -Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. -Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Change from Baseline in Hemoglobin A1c (HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy *1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) *2-hour PPG Excursion during MMTT *Rate of Severe Hypoglycemia *Rate of Documented Symptomatic Hypoglycemia *Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) *Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values *Change from Baseline in Insulin Dose *Change from Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score *Change from Baseline in ITSQ Lifestyle Flexibility Domain Score *Proportion of Participants with HbA1c <7% | — |
Countries
Japan
Outcome results
None listed