- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864977
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
August 18, 2021 updated by: Eli Lilly and Company
Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study
The main purpose of this study is to evaluate a novel approach for insulin glargine (LY2963016) titration for insulin-naïve adults with type 2 diabetes (T2D)
The study will last about 6 months.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults with type 2 diabetes as diagnosed by endocrinologist
- No insulin over past 3 months
- Inadequate glycemic control with A1c ≥8.0% at or within 1 month prior to screening visit
- No history of diabetic ketoacidosis (DKA) or severe hypoglycemia leading to mental status change in the past 6 months
- Willingness and ability to follow the protocol including willingness to commence basal insulin, wear CGM, and communicate with healthcare provider.
Exclusion Criteria:
- Contraindication to use of insulin glargine (e.g., allergy)
- Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY2963016
Participants with type 2 diabetes will be started on insulin glargine and dose will be titrated.
Insulin glargine will be delivered via insulin pen each evening subcutaneously (SC).
They will also check fasting blood glucose values on a study meter and prior to treating hypoglycemia.
Participants will be asked to report the time and dose of their last administration.
|
Participants administered basal insulin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)
Time Frame: Week 12
|
Percentage of participants with type 2 diabetes who achieve nadir glucose in range (70-125 mg/dl) over 15 consecutive minutes for ≥70% of days (typically 10 days) (last 14 days of active treatment)
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)
Time Frame: Week 12
|
Week 12
|
Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%
Time Frame: Week 12
|
Week 12
|
Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 16, 2021
Primary Completion (Anticipated)
June 6, 2022
Study Completion (Anticipated)
June 6, 2022
Study Registration Dates
First Submitted
April 27, 2021
First Submitted That Met QC Criteria
April 27, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 18, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18095
- I4L-MC-YCAA (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Time Frame
data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Basal Insulin
-
Mount Sinai Hospital, CanadaCanadian Institutes of Health Research (CIHR); University of TorontoCompleted
-
Guillermo Umpierrez, MDMedical University of South Carolina; Sanofi; Texas A&M UniversityCompletedHyperglycemia | Type 2 DiabetesUnited States
-
Assaf-Harofeh Medical CenterUnknown
-
Mannkind CorporationJaeb Center for Health ResearchActive, not recruitingDiabetes Mellitus, Type 1United States
-
Institut de Recherches Cliniques de MontrealMcGill University Health Centre/Research Institute of the McGill University...RecruitingType 1 Diabetes MellitusCanada
-
LMC Diabetes & Endocrinology Ltd.CompletedDiabetes Mellitus, Type 2Canada
-
Mayo ClinicCompleted
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedHyperglycemiaUnited States
-
Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbHCompletedDiabetes MellitusGermany
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, India, Mexico, Argentina, Slovenia, Romania