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Participants are eligible to be included in the study only if they meet all of the following criteria at screening |
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Type of Study Participant and Disease Characteristics (For Basal Switch) |
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Have a diagnosis of T2D according to the WHO criteria treated with basal insulin for ≥6 months |
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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 |
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DPP-4 inhibitors |
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SGLT-2 inhibitors |
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biguanides |
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alpha-glucosidase inhibitors |
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sulfonylureas |
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Note: All OAMs must be used in accordance with the corresponding local product label at the time of screening |
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Are receiving ≥10 U of basal insulin per day and ≤1.5 U/kg of basal insulin per day |
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Type of Study Participant and Disease Characteristics (For Insulin naive) |
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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 |
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Study Participant Characteristics |
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No male contraception required except in compliance with specific local government study requirements |
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Female participants |
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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 |
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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 |
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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 |
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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 |
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Women not of childbearing potential may participate and include those who are |
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infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or |
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post-menopausal – defined as either |
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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 |
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A woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or |
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A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy |
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Are 18 to 75 years of age, inclusive, at the time of signing the ICF |
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Have familiarity with the use of a smartphone |
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Cohort 1: Have a baseline HbA1c value of 7.0% to 9.5%, inclusive, as determined by the central lab at screening |
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Cohort 2: Have a baseline HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central lab at screening |
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BG target of 80-100 mg/dL is judged medically appropriate in the view of site investigators |
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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%) |
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In the investigator’s opinion, are well-motivated, capable, and willing to |
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perform daily fingerstick blood glucose monitoring |
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wear the Dexcom G6 Pro system for the duration of the study |
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maintain study diary, as required for this protocol |
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must have a normal wake/sleep pattern such that midnight to 0600 hours will reliably reflect a usual sleeping period |
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Are willing and able to follow the visit schedule during the complete duration of the trial |
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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 |
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Participants will be excluded from study enrollment if they meet any of the following criteria at screening
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Medical Conditions
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Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
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Have had any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
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Diagnosis of type 1 diabetes
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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)
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Gastrointestinal: have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (e.g., Lap-Band®) prior to screening
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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
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Total bilirubin >1.5x the upper limit of normal (ULN) in the absence of Gilbert’s syndrome, or
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Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.0x ULN, or
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Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) >2.0x ULN
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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
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Have fasting triglycerides >400 mg/dL or non-fasting >600 mg/dL
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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
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Have known hypersensitivity or allergy to any of the study medications or their excipients, or commonly used adhesives (e.g. CGM sensor adhesive)
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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
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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)
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Women of child-bearing potential who
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are pregnant or intend to become pregnant
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are lactating/breastfeeding (including the use of a breast pump)
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are unwilling to remain abstinent or use birth control as described in Inclusion Criteria 5b
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test positive for pregnancy at the time of screening (Visit 1)
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Note: a urine pregnancy test is conducted at Visit 3
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Prior/Concomitant Therapy
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Are taking drugs that may significantly affect glycemic control (e.g., niacin [allowed if <1.0 g/day], bile acid sequestrants or pentoxyphylline)
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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
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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
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T2D treatments
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Basal Switch population
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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
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Insulin-Naive population
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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)
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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)
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Are using or have used blood pressure-lowering medication at a dose that has not been stable for 1 month prior to screening
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Daily use of unblinded CGM, including flash glucose monitoring (FGM)
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Prior/Concurrent Clinical Trial Experience
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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
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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
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Have previously completed or withdrawn from this study or any other study investigating LY3209590
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Other Exclusions
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The participant is not available for all scheduled study visits
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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
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Are Lilly employees
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