Type 1 Diabetes
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants diagnosed with type 1 diabetes mellitus, based on the World Health Organaization classification. Have been on MDI therapy including a rapid acting insulin analog(Insulin lispro U-100, insulin aspart, insulin glulisine) for at least 90 days. Have been treated for at least 30 days prior to screening eith one of the following . a)Insulin glargine U-100 or U-300 b)Insulin detemir U-100 c)Insulin degludec U-100 or U-200 d)NPH Have an HBA1c value >=7.0 and <=9.5%, according to the central laboratory at screening. Participants who have a body mass index (BMI) of <=35.0 kilograms per meter squared (kg/m^2)
Exclusion criteria
Exclusion criteria: -Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening. -Have had more than 1 severe hypoglycemic episode within 6 months of screening. -Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening. -Have clinically significant gastrointestinal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy 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% *Change from Baseline in HbA1c | — |
Countries
Japan
Outcome results
None listed