The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
Administered SC
Administered SC
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.
Time frame: Baseline, Week 26
Change From Baseline in Fasting Serum Glucose
LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate.
Time frame: Baseline, Week 26
Change From Baseline in Bolus Insulin Dose
Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate.
Time frame: Baseline, Week 26
Rate of Documented Hypoglycemia
Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose \<54 mg/dL (3.0 millimole per liter (mmol/L)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants.
Time frame: Baseline through Week 26
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
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John Muir Physician Network Clinical Research Center
Concord, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, United States
East Coast Institute for Research at The Jones Center
Jacksonville, Florida, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Bayside Clinical Research, LLC
New Port Richey, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
...and 44 more locations
AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value.
Time frame: Week 26