This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03736785
Recruitment Status : Completed
First Posted : November 9, 2018
Results First Posted : March 8, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 2, 2018
First Posted Date  ICMJE November 9, 2018
Results First Submitted Date  ICMJE February 12, 2021
Results First Posted Date  ICMJE March 8, 2021
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE November 15, 2018
Actual Primary Completion Date February 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
Change From Baseline in HbA1c [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 32 ]
Change from baseline in HbA1c
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
  • Change From Baseline in HbA1c Compared to Insulin Degludec [ Time Frame: 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 Fasting Glucose [ Time Frame: 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 (LY3209590) [ Time Frame: Week 1, Week 32 ]
    The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.
  • Change From Baseline in Insulin Dose (Insulin Degludec) [ Time Frame: Baseline, Week 32 ]
    Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.
  • Rate of Total Documented Symptomatic Hypoglycemia [ Time Frame: 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.
  • Change From Baseline in Body Weight [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Change from Baseline in HbA1c Compared to Insulin Degludec [ Time Frame: Baseline, Week 32 ]
    Change from baseline in HbA1c compared to insulin degludec
  • Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 32 ]
    Change from baseline in fasting glucose
  • Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 32 ]
    Change from baseline in insulin dose
  • Rate of Total Documented Symptomatic Hypoglycemia [ Time Frame: Week 32 ]
    Rate of total documented symptomatic hypoglycemia
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 32 ]
    Change from baseline in body weight
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 [ Time Frame: Week 32 ]
    PK: AUC of LY3209590
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: LY3209590
    Administered SC
  • Drug: Insulin Degludec
    Administered SC
Study Arms  ICMJE
  • Experimental: LY3209590 Algorithm 1
    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).
    Intervention: Drug: LY3209590
  • Experimental: LY3209590 Algorithm 2
    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.
    Intervention: Drug: LY3209590
  • Active Comparator: 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%.
    Intervention: Drug: Insulin Degludec
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2021)
399
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
375
Actual Study Completion Date  ICMJE February 18, 2020
Actual Primary Completion Date February 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03736785
Other Study ID Numbers  ICMJE 17059
I8H-MC-BDCM ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP