Back to resultsA Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Insulin Glargine
LY3209590
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening
- Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening
Exclusion Criteria:
- Have an abnormality in the 12-lead ECG
- Have a supine blood pressure at screening
- Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit of normal (ULN)
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders
- Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy
- Have an average weekly alcohol intake
Sites / Locations
- Profil Institut für Stoffwechselforschung
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Insulin Glargine (Period 1)
LY3209590 (Period 2)
Arm Description
Insulin glargine administered subcutaneously (SC).
LY3209590 administered SC.
Outcomes
Primary Outcome Measures
Incidence of Documented Hypoglycemia
Incidence of Documented Hypoglycemia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04957914
Brief Title
A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
Official Title
Effects of LY3209590 on Frequency and Severity of Hypoglycaemia Under Conditions of Increased Hypoglycaemic Risk Compared to Insulin Glargine in Participants With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 1, 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
October 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Glargine (Period 1)
Arm Type
Active Comparator
Arm Description
Insulin glargine administered subcutaneously (SC).
Arm Title
LY3209590 (Period 2)
Arm Type
Experimental
Arm Description
LY3209590 administered SC.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
LY3209590
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Incidence of Documented Hypoglycemia
Description
Incidence of Documented Hypoglycemia
Time Frame
Baseline through Day 186
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening
Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening
Exclusion Criteria:
Have an abnormality in the 12-lead ECG
Have a supine blood pressure at screening
Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit of normal (ULN)
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders
Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy
Have an average weekly alcohol intake
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
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