Health Condition 1: null- Type 2 Diabetes Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: LY900014 - Ultra rapid insulin: Study I8B-MC-ITRN is a Phase 3 study to evaluate LY900014 compared to insulin lispro each in
combination with basal insulin glargine or degludec in patie
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening 2.Are at least 18 years of age 3.Have been treated for at least 90 days prior to screening with: a) Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or NPH insulin)in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or b) Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily 4.Patients may be treated with up to 3 of the following OAMs in accordance with local regulations: Metformin Dipeptidyl peptidase-4 (DPP-4) inhibitor Sodium glucose cotransporter 2 (SGLT2) inhibitor Sulfonylurea Meglitinide Alpha-glucoside inhibitor Doses of OAMs are required to have been stable for at least 90 days prior to screening. Combination medications (2 or more medications in 1 pill) should be counted as the number of individual components. During the study lead-in and treatment periods, patients may continue the use of up to 2 of the following OAMs: metformin, SGLT2 inhibitor. Other prestudy OAMs will be discontinued at the beginning of the lead-in period. Please also refer to management of OAMs in Section 7.7.1. 5. Have an HbA1c value between ââ?°Â¥7.0 and ââ?°Â¤10.0%, according to the central laboratory at the time of screening (Visit 1). 6. Have a body mass index (BMI) of ââ?°Â¤45.0 kg/m2 at screening (Visit 1). 7. Male patients: a) No male contraception required except in compliance with specific local government study requirements. 8. Female patients: a) Women not of childbearing potential may participate and include those who are: i) infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; Or ii) postmenopausal ââ?¬â?? defined as either (1) a woman 50 to 54 years of age (inclusive) with an intact uterus, not on hormone therapy who has had either (a) cessation of menses for at least 1 year; Or (b) at least 6 months of spontaneous amenorrhea with a folliclestimulating hormone >40 mIU/mL; Or (2) a woman 55 or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; Or (3) a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy. b) Women of childbearing potential participating: i) Cannot be pregnant or intend to become pregnant, ii) Cannot be breastfeeding (including the use of a breast pump), iii) must remain abstinent or use 1 highly effective method of contraception or a combination of 2 effective methods of contraception for the entirety of the study (Appendix 7), iv) Test negative for pregnancy at the time of screening (Visit 1). Note: a urine pregnancy test is conducted at Visit 8. 9.Have access to a telephone, or alternative means for close monitoring/communications, and have access to a reliable cellular signa
Exclusion criteria
Exclusion criteria: 1.Having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the patient from following and completing the protocol 2.Have been diagnosed, at any time, with T1D or Latent Autoimmune Diabetes in Adults 3.Have hypoglycemia unawareness as judged by the investigator 4.Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening 5.Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening 6.Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy) 7.Excessive insulin resistance defined as having received a total daily dose of insulin >2.0 U/kg at the time of screening 8. Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve 9.Have cardiovascular disease, within the last 6 months prior to screening, defined as stroke, decompensated heart failure New York Heart Association class III or IV myocardial infarction, unstable angina pectoris or coronary arterial bypass graft 10 Renal a) History of renal transplantation b) Currently receiving renal dialysis c) Serum creatinine >2.0 mg/dL (177 �¼mol/L) at screening 11. Hepatic: Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements as indicated below at screening: a) Total bilirubin level (TBL) â�¥2Xthe upper limit of normal (ULN [with the exception of Gilberts Disease]) as defined by the central laboratory, Or b) Alanine aminotransferase (ALT) â�¥3X ULN as defined by the central laboratory, Or c) Aspartate aminotransferase (AST) â�¥3X ULN as defined by the central laboratory 12. Malignancy: Have active or untreated malignancy, 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 an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator 13. Having any hypersensitivity or allergy to any of the insulins or excipients used in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the hypothesis that LY900014 IS Non-inferior to Insulin Lispro on glycemic control in patients with T2DTimepoint: Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| To test the hypothesis that LY900014 is superior to insulin lispro in controlling 1-hour postprandial glucose (PPG) excursions, when administered as prandial insulinTimepoint: Difference between LY900014 and insulin lispro in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a mixed-meal tolerance test (MMTT) at Week 26;To test the hypothesis that LY900014 is superior to insulin lispro in controlling 2-hour PPG excursions when administered as prandial insulinTimepoint: Difference between LY900014 and insulin lispro in the 2-hour PPG excursion (serum glucose measured 2 hours after the start of the meal minus fasting serum glucose) from an MMTT test at Week 26;To test the hypothesis that LY900014 is superior to insulin lispro on improving glycemic control (HbA1c) when administered as prandial insulinTimepoint: Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c | — |
Countries
Argentina, Australia, Czech Republic, Germany, Hungary, India, Italy, Japan, Mexico, Republic of Korea, Russian Federation, Slovakia, Spain, Taiwan, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed