A Study of LY3209590 in Participants With Type 1 Diabetes

Overview

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.

Full Title of Study: “A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2021

Interventions

  • Drug: LY3209590
    • Administered SC
  • Drug: Insulin Degludec
    • Administered SC

Arms, Groups and Cohorts

  • Experimental: LY3209590 Algorithm 1 (Paper)
    • Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 milligrams per deciliter (mg/dL).
  • Experimental: LY3209590 Algorithm 2 (Digital)
    • Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL. As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry.
  • Active Comparator: Insulin Degludec
    • Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Hemoglobin A1c (HbA1c)
    • Time Frame: Baseline, Week 26
    • 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.

Secondary Measures

  • Change From Baseline in Fasting Serum Glucose
    • Time Frame: Baseline, Week 26
    • 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.
  • Change From Baseline in Bolus Insulin Dose
    • Time Frame: Baseline, Week 26
    • 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.
  • Rate of Documented Hypoglycemia
    • Time Frame: Baseline through Week 26
    • 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.
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
    • Time Frame: Week 26
    • AUC of LY3209590 was calculated for individual participants using the participant’s Week 26 LY3209590 dose amount and the estimated clearance value.

Participating in This Clinical Trial

Inclusion Criteria

  • Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year – Participants must have been using multiple daily injections without interruption for at least 3 months – Participants must have HbA1c values of 5.6% to 9.5%, inclusive – Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²) Exclusion Criteria:

  • Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening – Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening – Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke) – Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease – Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m² – Have active or untreated cancer – Are receiving chronic (>14 days) systemic glucocorticoid therapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5hours, EST), Study Director, Eli Lilly and Company

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