The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
399
Administered SC
Administered SC
Change From Baseline in HbA1c
HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.
Time frame: Baseline, Week 32
Change From Baseline in HbA1c Compared to Insulin Degludec
HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate.
Time frame: Baseline, Week 32
Change From Baseline in Fasting Glucose
Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry, HbA1c strata \[\<8.5% or ≥8.5%\]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate.
Time frame: Baseline, Week 32
Change From Baseline in Insulin Dose (LY3209590)
The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.
Time frame: Week 1, Week 32
Change From Baseline in Insulin Dose (Insulin Degludec)
Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.
Time frame: Baseline, Week 32
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Central Research Associates, Inc.
Birmingham, Alabama, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
AMCR Institute INC
Escondido, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
Marin Endocrine Associates
Greenbrae, California, United States
National Research Institute
Huntington Park, California, United States
First Valley Medical Group
Lancaster, California, United States
National Research Institute
Los Angeles, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
...and 34 more locations
Rate of Total Documented Symptomatic Hypoglycemia
The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants.
Time frame: Baseline through week 32
Change From Baseline in Body Weight
Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate.
Time frame: Baseline, Week 32
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value.
Time frame: Week 32