An early Feasibility Study to Evaluate the Safety and Functionality of an Individual Accruing Data Algorithm with LY3209590 in Adult Participants with Type 2 Diabetes

  • End date
    Oct 16, 2023
  • sponsor
    Eli Lilly
Updated on 28 September 2022


Objective: A multi-center, open label parallel device feasible study with two sequential study cohort in adult participates with Type 2 Diabetes Mellitus (T2D) who are currently treated with basal insulin or are insulin naïve.


Study I8H-MC-BDCT (BDCT) is a multicenter, non-randomized, open-label, parallel, early feasibility study with two sequential cohorts. The study is designed to evaluate the safety and functionality of the investigational IADA for LY3209590 in adult participants with T2D that are currently treated with basal insulin or are insulin naive. Cohort 1 and Cohort 2 will have approximately 15 participants from each T2D treatment population.

During Cohort 1, participant-level glucose, hypoglycemia, LY3209590 dosing data and investigator dose recommendation overrides will be reviewed in conjunction with IADA functionality. Based on findings from these reviews, changes to further optimize safety and functionality may be made to the IADA prior to initiation of Cohort 2. Any changes will be thoroughly assessed via simulations and verification and validation testing. The same clinical controls including close investigator follow-up and the ability for investigators to override any dose recommendations will remain in Cohort 2. If any new risks identified between cohorts, then the protocol will be amended.

Each cohort will consist of 4 periods and will have the same Schema and Schedule of Activities :
  • Study Period 1: screening, up to 4 weeks
  • Study Period 2: lead-in, approximately 2 weeks
  • Study Period 2: treatment period, approximately 16 weeks
  • Study Period 3: safety follow-up period, approximately 5 weeks

Condition Diabetes Mellitus Types I and II
Clinical Study IdentifierTX307739
SponsorEli Lilly
Last Modified on28 September 2022


Yes No Not Sure

Inclusion Criteria

Participants are eligible to be included in the study only if they meet all of the following criteria at screening
Type of Study Participant and Disease Characteristics (For Basal Switch)
Have a diagnosis of T2D according to the WHO criteria treated with basal insulin for ≥6 months
Have a stable regimen of insulin glargine (U100 or U300), insulin Levemir, or insulin degludec (U100 or U200) with or without OAM therapy prior to screening for ≥3 months and be willing to continue stable dosing throughout the study. Acceptable OAMs include up to 3 of the following
DPP-4 inhibitors
SGLT-2 inhibitors
alpha-glucosidase inhibitors
Note: All OAMs must be used in accordance with the corresponding local product label at the time of screening
Are receiving ≥10 U of basal insulin per day and ≤1.5 U/kg of basal insulin per day
Type of Study Participant and Disease Characteristics (For Insulin naive)
Cohort 1: Have a diagnosis of T2D treated with a stable dose of metformin (alone or in combination with a stable dose of a DPPIV inhibitor and/or a SGLT2 inhibitor) for at least 3 months prior to screening. Cohort 2: Have a diagnosis of T2D treated with a stable dose of 1 or more of the following antidiabetic medications: metformin, a DPPIV inhibitor, sulfonylurea, and/or a SGLT2 inhibitor for at least 3 months prior to screening
Study Participant Characteristics
No male contraception required except in compliance with specific local government study requirements
Female participants
Women of child-bearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same sex relationship without sexual relationships with males. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception
Otherwise, women of child-bearing potential participating must agree to use 1 highly effective method (less than 1% failure rate) of contraception, or a combination of 2 effective methods of contraception for the entirety of the study
Women of child-bearing potential participating must test negative for pregnancy prior to initiation of treatment as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to exposure
Either 1 highly effective method of contraception (such as combination oral contraceptives, implanted contraceptives or intrauterine device) or a combination of 2 effective methods of contraception (such as male or female condoms with spermicide, diaphragms with spermicide or cervical sponges) will be used. The participant may choose to use a double barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined
Women not of childbearing potential may participate and include those who are
infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or
post-menopausal – defined as either
A woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle stimulating hormone >40 mIU/mL; or
A woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or
A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
Are 18 to 75 years of age, inclusive, at the time of signing the ICF
Have familiarity with the use of a smartphone
Cohort 1: Have a baseline HbA1c value of 7.0% to 9.5%, inclusive, as determined by the central lab at screening
Cohort 2: Have a baseline HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central lab at screening
BG target of 80-100 mg/dL is judged medically appropriate in the view of site investigators
Have a body mass index (BMI) between 20 and 45 kg/m2, inclusive and weight between 52-198 kg, with no significant weight gain or loss in the past 3 months (≥5%)
In the investigator’s opinion, are well-motivated, capable, and willing to
perform daily fingerstick blood glucose monitoring
wear the Dexcom G6 Pro system for the duration of the study
maintain study diary, as required for this protocol
must have a normal wake/sleep pattern such that midnight to 0600 hours will reliably reflect a usual sleeping period
Are willing and able to follow the visit schedule during the complete duration of the trial
Informed Consent: Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

Participants will be excluded from study enrollment if they meet any of the following criteria at screening
Medical Conditions
Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
Have had any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
Diagnosis of type 1 diabetes
Cardiovascular (CV): have had any of the follow CV conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
Gastrointestinal: have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (e.g., Lap-Band®) prior to screening
Hepatic: have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease except non-alcoholic fatty liver disease (NAFLD) (i.e., participants with NAFLD are eligible for participation), and/or have elevated liver enzyme measurements, as determined by the central laboratory at screening and as indicated below
Total bilirubin >1.5x the upper limit of normal (ULN) in the absence of Gilbert’s syndrome, or
Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.0x ULN, or
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) >2.0x ULN
Renal: have an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology equation, as determined by the central laboratory at screening
Have fasting triglycerides >400 mg/dL or non-fasting >600 mg/dL
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
Have known hypersensitivity or allergy to any of the study medications or their excipients, or commonly used adhesives (e.g. CGM sensor adhesive)
Have any other serious disease or condition (for example, known drug or alcohol abuse/regular consumption or psychiatric disorder) that, in the opinion of the investigator, would pose a significant risk to the patient, preclude the patient from following and completing the protocol, or interfere with the interpretation of safety or PK data. Alcohol abuse/regular consumption is defined as an average daily intake of >3 units for males or >2 units for females within 6 months prior to the study. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have any hematologic condition that may interfere with HbA1c measurement (e.g., hemoglobinopathy, hemolytic anemia, sickle-cell disease)
Women of child-bearing potential who
are pregnant or intend to become pregnant
are lactating/breastfeeding (including the use of a breast pump)
are unwilling to remain abstinent or use birth control as described in Inclusion Criteria 5b
test positive for pregnancy at the time of screening (Visit 1)
Note: a urine pregnancy test is conducted at Visit 3
Prior/Concomitant Therapy
Are taking drugs that may significantly affect glycemic control (e.g., niacin [allowed if <1.0 g/day], bile acid sequestrants or pentoxyphylline)
Are receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, or inhaled preparations) or have received such therapy for >14 days within the month preceding screening
Are currently taking or have taken within the 3 months preceding screening, prescription or over-the-counter medications to promote weight loss. Participants who participate must agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
T2D treatments
Basal Switch population
Are receiving a glitazone, a glucagon-like peptide 1 (GLP-1) receptor agonist, prandial insulin, insulin mixtures, Neutral Protomine Hagedorn (NPH) insulin, or twice daily basal insulin; also, if receiving <10 units of insulin per day or >1.5 units/kg of insulin per day
Insulin-Naive population
Cohort 1: Have been treated with a sulfonylurea (SU), a glitazone, alpha-glucosidase inhibitor, and a GLP-1 receptor agonist within the past 3 months or insulin in the 6 months prior to screening with the exception of short-term use of insulin for acute conditions (<14 days within the last 6 months prior to screening)
Cohort 2: Have been treated with a glitazone, alpha-glucosidase inhibitor, and a GLP-1 receptor agonist within the past 3 months or insulin in the 6 months prior to screening with the exception of short-term use of insulin for acute conditions (<14 days within the last 6 months prior to screening)
Are using or have used blood pressure-lowering medication at a dose that has not been stable for 1 month prior to screening
Daily use of unblinded CGM, including flash glucose monitoring (FGM)
Prior/Concurrent Clinical Trial Experience
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
Have previously completed or withdrawn from this study or any other study investigating LY3209590
Other Exclusions
The participant is not available for all scheduled study visits
Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Are Lilly employees
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note