A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

JRCT ID: jRCT2071220041

Registered date:19/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 1 Diabetes Diabetes
• Date of first enrollment: 03/10/2022
• Target sample size: 670
• Countries of recruitment: Argentina,Japan,India,Japan,Poland,Japan,Puerto Rico,Japan,Slovakia,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: LY3209590
Administered SC
Drug: Insulin Degludec
Administered SC

Study Arms
Experimental: LY3209590
Participants will receive LY3209590 by subcutaneously (SC)
Intervention: Drug: LY3209590
Active Comparator: Insulin Degludec
Participants will receive insulin degludec SC
Intervention: Drug: Insulin Degludec

Outcome(s)

• Primary Outcome: Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
Have a body mass index of <=35 kilogram/square meter (kg/m2)

Exclude criteria

Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05463744