Health Condition 1: null- Type 1 diabetes Health Condition 2: E109- Type 1 diabetes mellitus without complications
Conditions
Interventions
Intervention1: LY900014- Ultra Rapid Insulin: The aim of this study is to demonstrate that an ultra-rapid formulation of insulin lispro, LY900014, is noninferior to
insulin lispro on glycemic control
however, the general consensus is that they are not rapid enough to match carbohydrate absorption,
whether delivered by pump or syringe/pen injector, limiting efficacy. An ultra-rapid-acting prandial
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women diagnosed (clinically) with T1D, based on the(WHO) classification (Appendix 5) for at least 1 year prior to screening, and continuously using insulin for at least 1 year 2. Are at least 18 years of age 3. Have been on MDI therapy including a rapid acting insulin analog (insulin lispro U-100, insulin aspart, insulin glulisine) for at least 90 days 4. Have been treated for at least 30 days prior to screening with one of the following: a) Insulin glargine U-100 or U-300 b) Insulin detemir U-100 c) Insulin degludec U-100 or U-200 d) NPH 5. Have an HbA1c value >=7.0 and screening (Visit 1). 6. Have a body mass index (BMI) of 7. Male patients: a) No male contraception required except in compliance with specific local government study 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 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 (See 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 and communications, and have access to a reliable cellular signal for transmission of the electronic clinical outcomes assessment (eCOA) data 10.Patient whom the investigator has determined can be randomized and maintain the treatment regimens based on their previous medical history including insulin dosing regimens, hypoglycemic episodes, and glycemic control 11.Capable of, willing, and desirous to do the following: a) Inject insulin with the use of an insulin injection device (insulin pen) according to included directions b) Perform self-BG monitoring including 10-point SMBG on designated days (patients using a personal CGM device for insulin dosing decisions must still perform the SMBG per protocol) c) Keep records in eCOA as required by this protocol d) Participate in two 4-hour mixed-meal tolerance tests (MMTTs) and consume a standardized meal for the tests e) Follow an algorithm for basal insulin adjustment and individualized prandial insulin dosi
Exclusion criteria
Exclusion criteria: 1.Have any other condition (including known drug or alcohol abuse, or psychiatric disorder including eating disorder) that precludes the patient from following and completing the protocol 2. Have hypoglycemia unawareness as judged by the investigator 3. Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the last6 months prior to screening 4. Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening (Visit 1) 5. 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 (see Appendix 6), myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft 6. Renal: a) History of renal transplantation b) Currently receiving renal dialysis c) Serum creatinine >2.0 mg/dL (177 μmol/L) at screening 7.symptoms of liver disease (for example, acute or chronic hepatitis, or cirrhosis) or elevated liver enzyme measurements as indicated below at screening (Visit 1): a) Total bilirubin level (TBL) >=2X the upper limit of normal (ULN) (with the exception of Gilberts Disease) as defined by the central laboratory, OR b) Alanine aminotransferase (ALT) >=3X ULN as defined by the central laboratory OR c) Aspartate aminotransferase (AST) >=3X ULN as defined by the central laboratory 8. 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 9. Have any hypersensitivity or allergy to any of the insulins or excipients used in this trial 10. Have hypersensitivity or allergy to any of the ingredients in the standardized test meal (MMTT) (for example, nut allergy) 11. Hematologic: Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia, or any other traits known to interfere with measurement of HbA1c 12. Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigatorâ??s opinion 13.Have excessive insulin resistance defined as having received a total daily dose of insulin >1.5 U/kg at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the hypothesis that LY900014 is non-inferior to Insulin Lispro on glycemic control in patient with T1DTimepoint: 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 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, Austria, Brazil, Germany, Greece, India, Italy, Japan, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed