A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
- Conditions
- Diabetes,Type 2 Diabetes
- Registration Number
- JPRN-jRCT2031220290
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 912
Have diagnosis of T2D according to the World Health Organization Criteria
-Have an HbA1c of 7.0% - 10% inclusive, at screening
-Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study
-Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
-Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
-Have had severe hypoglycemia episodes within 6 months prior to screening.
-Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
-Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
-acute myocardial infarction
-cerebrovascular accident (stroke), or
-coronary bypass surgery.
-Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
-Have had significant weight gain or loss within 3 months prior to screening, for example,>= 5%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method