Diabetes Mellitus, Type 2Phase 2NCT07215312
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
A Phase 2 study testing LY3938577 and Degludec in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 26 sites in 2 countries.
Trial summary
The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3938577 and Degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 13 Oct 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes
- Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening
- Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive
- Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)
Who cannot join
- Have type 1 diabetes
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States20 sites
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
Holston Medical Group
Bristol, Tennessee, 37620
Tampa Bay Medical Research
Clearwater, Florida, 33761
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Encore Medical Research
Hollywood, Florida, 33024
Juno Research
Houston, Texas, 77040
Clinical Research of Central Florida
Lakeland, Florida, 33805
Southern Endocrinology Associates
Mesquite, Texas, 75149
AMR Clinical
Norman, Oklahoma, 73069
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Encompass Clinical Research
Spring Valley, California, 91978
Washington University School of Medicine
St Louis, Missouri, 63110
Chrysalis Clinical Research
St. George, Utah, 84790
Tucson Clinical Research Institute
Tucson, Arizona, 85712
University Clinical Investigators, Inc.
Tustin, California, 92780
Texas Valley Clinical Research
Weslaco, Texas, 78596
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
Encore Medical Research - Weston
Weston, Florida, 33331
Accellacare - Wilmington
Wilmington, North Carolina, 28401
Argentina6 sites
Cicemo Srl
Buenos Aires, 1424
CIPREC
Buenos Aires, C1119ACN
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC
Instituto Centenario
CABA, 1204
Instituto Médico Catamarca IMEC
Rosario, 2000
About this study
Official title: A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin
The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3938577, Degludec
- Keywords
- Glycemic control, Hypoglycemia, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3938577Drug
Administered SC
DegludecDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3938577 | Experimental | Participants will receive LY3938577 subcutaneously (SC) Receives: Drug: LY3938577 |
| Degludec | Active comparator | Participants will receive degludec SC Receives: Drug: Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
Measured: Baseline through Week 20
Secondary outcomes (3)
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)
Measured: Baseline through Week 20
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 20
Pharmacokinetics (PK): Average Concentration of LY3938577
Measured: Baseline through Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start13 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215312
- Sponsor's protocol ID
- 27409
- Other IDs
- J4P-MC-IYAC
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin
- ClinicalTrials.gov ID
- NCT07215312
- Acronym / sponsor ID
- 27409
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Glycemic control, Hypoglycemia, Hyperglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3938577 | Experimental | Drug: LY3938577Participants will receive LY3938577 subcutaneously (SC) |
| Degludec | Active comparator | Drug: DegludecParticipants will receive degludec SC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have type 2 diabetes
- Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening
- Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive
- Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)
Key exclusion criteria (1 listed)
- Have type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3938577Administered SC | Drug | LY3938577 |
| DegludecAdministered SC | Drug | Degludec |
Primary outcome
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
Time frame: Baseline through Week 20
3 secondary outcomes
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)
Time frame: Baseline through Week 20
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 20
Pharmacokinetics (PK): Average Concentration of LY3938577
Time frame: Baseline through Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal InsulinLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3938577 and Degludec in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis) (time frame: Baseline through Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.