Comparison of LY900014 to Insulin Lispro in Adults with Type 1 Diabetes
- Conditions
- Health Condition 1: null- Type 1 diabetesHealth Condition 2: E109- Type 1 diabetes mellitus without complications
- Registration Number
- CTRI/2017/09/009591
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
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 <=9.5%, according to the central laboratory at
screening (Visit 1).
6. Have a body mass index (BMI) of <=35.0 kg/m2 at screening (Visit 1).
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>in change from baseline to Week 26 in HbA1c
- Secondary Outcome Measures
Name Time Method