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Protocol NumberI4L-MC-ABER

2014-12-01 - 2016-07-31

Phase III

Terminated7

ICD-10E11.65

Type 2 diabetes mellitus with hyperglycemia

ICD-9250.02

Diabetes mellitus without mention of complication, Type II [non-insulin dependent type] [NIDDM type] [ adult-onset type ] or unspecified type, uncontrolled

Prospective, randomized, open, and comparative long-acting basal insulin analogue LY2963016 and LANTUS® (LANTUS®) in adults with type 2 diabetes: ELEMENT 5 trial.

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Hsieh Hsieh Division of Endocrinology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 黃建寧 Division of Endocrinology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 裴馰 Division of Endocrinology
Cardinal Tien Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 盧永川 Division of Endocrinology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳弘聖 Division of Family Medicine
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Kun Der Lin Division of Endocrinology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ching-Chu Chen Division of Endocrinology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Type 2 diabetes

Objectives

The main purpose is to test the following hypothesis-when combined with oral hypoglycemic drugs, the efficacy of LY2963016 once a day is not inferior to that of RANDEX once a day. The test basis is the change in the value of glycosylated hemoglobin (HbA1c) from the base period to 24 weeks. The key and secondary objectives (gate method) are:  Test the hypothesis-when combined with oral hypoglycemic drugs, RANDEX is not inferior to LY2963016 once a day, and the test index is the change in HbA1c value from the base period to 24 weeks.  Test the hypothesis-in acceptance Before the trial, LY2963016 was not inferior to RANDEX in the combined use of oral hypoglycemic drugs in the subgroup of RANDEX patients. The test was based on the change in HbA1c value from the base period to 24 weeks. Other secondary objectives of this trial are as follows:  Compare the safety of LY2963016 relative to RANDEX (anti-insulin antibodies, hypoglycemia, adverse events including allergic reactions [AE] and other laboratory values) under the concurrent use of oral hypoglycemic drugs Abnormal incidence)  Compare other efficacy variables of LY2963016 relative to RANDEX (change in HbA1c value; percentage of patients with HbA1c value <7%; HbA1c value at 4, 8, 12, 16, 20 and 24 weeks≤ 6.5% of patients; at 7 time points (SMBG) at 0, 2, 12, and 24 weeks of self-monitoring blood glucose measurement overview [converted to plasma equivalent])  At 0, 2, 4, and 24 At 8, 12, 16, 20 and 24 weeks, under the combined use of OAM, compare the blood glucose (BG) variability, basal insulin dose and body weight of the same patient with LY2963016 compared to RANDS.  Compare LY2963016 with RANDS’s patient notification treatment Outcome (PRO), measured based on the 4th, 12th and 24th week of the insulin treatment satisfaction questionnaire (ITSQ) response

Test Drug

LY2963016

Active Ingredient

Basal insulin V (BIV)

Dosage Form

Injection solution

Dosage

100

Endpoints

The main purpose is to test the following hypothesis-when combined with oral hypoglycemic drugs, the efficacy of LY2963016 once a day is not inferior to that of RANDEX once a day. The test basis is the change in the value of glycosylated hemoglobin (HbA1c) from the base period to 24 weeks.
The key and secondary objectives (gate method) are:  Test the hypothesis-when combined with oral hypoglycemic drugs, RANDEX is not inferior to LY2963016 once a day, and the test index is the change in HbA1c value from the base period to 24 weeks.  Test the hypothesis-in acceptance Before the trial, LY2963016 was not inferior to RANDEX in the combined use of oral hypoglycemic drugs in the subgroup of RANDEX patients. The test was based on the change in HbA1c value from the base period to 24 weeks. The other secondary objectives of this trial are as follows:  Compare the safety of LY2963016 relative to RANDEX (anti-insulin antibodies, hypoglycemia, adverse events including allergic reactions [AE] and other laboratory values) under the concurrent use of oral hypoglycemic drugs Abnormal incidence)  Compare other efficacy variables of LY2963016 relative to RANDEX (change in HbA1c value; percentage of patients with HbA1c value <7%; HbA1c value at 4, 8, 12, 16, 20, and 24 weeks ≤ 6.5% of patients; at 7 time points (SMBG) at 0, 2, 12, and 24 weeks of self-monitoring blood glucose measurement overview [converted to plasma equivalent])  At 0, 2, 4, and 24 At 8, 12, 16, 20, and 24 weeks, and using OAM, compare LY2963016 with respect to the same patient’s blood glucose (BG) variability, basal insulin dose and body weight  Compare LY2963016 with RAND’s patient notification treatment Outcome (PRO), measured based on the 4th, 12th and 24th week of the insulin treatment satisfaction questionnaire (ITSQ) response.

Inclution Criteria

Suffering from type 2 diabetes, age 18 years or older and body mass index (BMI) ≤ 45 kg/m2, have received stable doses of 2 or more oral hypoglycemic drugs for at least 90 days before the first visit (regardless of whether Patients using basal insulin will be included in the trial. If they are currently using basal insulin, patients must use RANDEX, NPH insulin, or Levemir (insulin detemir) once a day (QD) or twice a day (BID) At least 90 days. The patient's HbA1c value must be greater than or equal to 7.0%, if insulin has not been used, it must be less than or equal to 11.0%; if the pre-test basal insulin is accepted, the HbA1c value must be less than or equal to 11.0%.
If the patient has used the biosimilar drug insulin glargine in the past 90 days, used Landex at a dose higher than the once-daily dose in the first 30 days, or used other insulin in the first 30 days (insulin treatment entered into the trial (Landex) , Levemir or NPH insulin]), including those already on the market (including any pre-mixed insulin) and insulin under trial, will be excluded. Patients with obvious liver, heart, or gastrointestinal disease will be excluded. Patients with active cancer or cancer (except basal cell carcinoma or carcinoma in situ) within 5 years will be excluded. Patients who are excessively resistant to insulin (ie, the total insulin dose is greater than or equal to 1.5 U/kg), or who are allergic to or have allergic reactions to RANDEX or its excipients will be excluded.

Exclusion Criteria

*HbA1c glycosylated hemoglobin> 10%
*Poor blood glucose control, diabetes treatment may need to be changed during the trial (non-insulin drug therapy, exercise therapy, diet therapy)
*Have other severe pain that is not related to diabetic peripheral neuropathy (DPN) and may confuse the evaluation of DPNP
*Have a neurological disorder that is not related to DPN and may confuse the evaluation of DPNP

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    492 participants

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