A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03736785
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
-
Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
- dipeptidyl peptidase-4 (DPP-4) inhibitors
- sodium-glucose cotransporter (SGLT-2) inhibitors
- biguanides
- alpha-glucosidase inhibitors
- sulfonlyureas
-
HbA1c value of 6.5% to 10%, inclusive
-
Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive
- Type 1 diabetes mellitus or latent autoimmune diabetes
- Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
- Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
- Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2
- Active or untreated malignancy
- Chronic (>14 days) systemic glucocorticoid therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3209590 Algorithm 2 LY3209590 Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of \<120 mg/dL. LY3209590 Algorithm 1 LY3209590 Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of \<140 milligram per deciliter (mg/dL). Insulin Degludec Insulin Degludec Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C \<7%.
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c Baseline, Week 32 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in HbA1c Compared to Insulin Degludec Baseline, Week 32 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.Change From Baseline in Insulin Dose (LY3209590) Week 1, Week 32 The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.
Change From Baseline in Body Weight Baseline, Week 32 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.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 Week 32 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.
Change From Baseline in Fasting Glucose Baseline, Week 32 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.
Change From Baseline in Insulin Dose (Insulin Degludec) Baseline, Week 32 Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.
Rate of Total Documented Symptomatic Hypoglycemia Baseline through week 32 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.
Trial Locations
- Locations (42)
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
🇺🇸Los Angeles, California, United States
First Valley Medical Group
🇺🇸Lancaster, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Scroll for more (32 remaining)Central Research Associates, Inc.🇺🇸Birmingham, Alabama, United States