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Clinical Trials List

Protocol NumberI4L-MC-ABEC
NCT Number(ClinicalTrials.gov Identfier)NCT01421459

2011-07-01 - 2013-12-31

Phase III

Terminated8

ICD-10E11.9

Type 2 diabetes mellitus without complications

ICD-10E13.9

Other specified diabetes mellitus without complications

ICD-9250.00

Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled

A prospective, randomized, double-blind trial comparing the long-acting basal insulin analogue LY2963016 and Lantus® in adult patients with type 2 diabetes

  • 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 盧介祥 Division of Endocrinology
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ching-Chu Chen Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

  • 黃國欽 Division of General Internal Medicine
  • 王子源 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 嚴逢杰 Division of Endocrinology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chen-Ling Huang Division of Endocrinology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator AN-TSZ HSIEH Division of Endocrinology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 江珠影 Division of Endocrinology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 何俊緯 Division of Endocrinology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator LEE-MING CHUANG Division of Endocrinology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Type 2 diabetes

Objectives

Test the effect of LY2963016 once a day (QD) and oral hypoglycemic drugs (OAMs), not inferior to the hypothesis of the effect of RANDEX (QD) and oral hypoglycemic drugs (OAMs), based on glycosylated hemoglobin (HbA1c) concentration The change from the base period to 24 weeks later is the measurement standard.

Test Drug

LY2963016

Active Ingredient

insulin glargine

Dosage Form

injection

Dosage

100

Endpoints

The change of glycosylated hemoglobin (HbA1c) from the base period to the test index is defined as the value at the 24th week or the observation advancement value (LOCF) after the last base period.
Secondary test indicators:
•7-time self-monitoring of blood glucose (SMBG) (before meals, after breakfast and lunch, before going to bed and 3 am).
• The patient's autologous changes, measured by the standard deviation (SD) of fasting blood glucose.
• The change of glycosylated hemoglobin (HbA1c) from the base period to the 4th, 8, 12, 16 and 20 weeks or the observation advancement value (LOCF) after the last base period.
•The percentage of patients with glycosylated hemoglobin (HbA1c) <7%; the percentage of patients with glycosylated hemoglobin (HbA1c)≦6.5%.
• The base insulin dose expressed in total dosage units/day and dosage units/kg.
•body weight.
•Patients who reflect the results of ALBSS and ITSQ self-report the results.

Inclution Criteria

This study will include type 2 with age ≧18 years old, body mass index ≦45, and having taken 2 or more oral hypoglycemic drugs (including or excluding Landers) for at least 12 weeks before the first visit Diabetics. Patients who have not received insulin therapy and HbA1c ≧7.0% and ≦11.0%; If Rander has been used before the start of the study, hemoglobin A1c (HbA1c)≦11.0%.

Exclusion Criteria

Patients suffering from major liver, heart, or gastrointestinal diseases will not be able to participate in this study. Patients with active cancer or cancer (except basal cell carcinoma or carcinoma in situ) in the past 5 years will not be able to participate in this study. Patients who are highly resistant to insulin (for example: total insulin dose ≧1.5U/kg) or are allergic to Lantus® or its excipients are also unable to participate in this study.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    792 participants

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