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Clinical Trials List

Protocol NumberI4L-MC-ABEG

2013-12-01 - 2015-09-30

Phase III

Terminated9

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, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Patients with Type 2 Diabetes Mellitus: The ELEMENT 4 Study

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor
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 陳榮福 Division of Endocrinology

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 嚴逢杰 Division of Endocrinology

Chi Mei Medical Center

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 林世鐸 Division of Endocrinology

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳弘聖 Division of Endocrinology

Kuang Tien General 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 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 II diabetes

Objectives

The primary objective of this study is to test the hypothesis that LY2963016 administered once daily (QD) is noninferior to Lantus (QD), as measured by change in hemoglobin A1c (HbA1c) from baseline to 24 weeks, when used in combination with oral antihyperglycemic medications (OAMs).

Test Drug

Insulin Basal Analog V (LY2963016)

Active Ingredient

Insulin Basal Analog V

Dosage Form

Injection

Dosage

100 U/mL

Endpoints

The primary objective of this study is to test the hypothesis that LY2963016 administered once daily(QD) is noninferior to Lantus (QD), as measured by change in hemoglobin A1c (HbA1c) from baseline to 24 weeks, when used in combination with oral antihyperglycemic medications (OAMs).

Inclution Criteria

[1] Have T2DM based on the disease diagnostic criteria World Health
Organization (WHO) classification
[2] Are ≥20 and ≤75 years of age.
[3]Body mass index (BMI) ≤45 kg/m2.
[4]Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to Visit 1.
[5]Have an HbA1c ≥7.0% and ≤11.0%.

Exclusion Criteria

[1]Have one of the following concomitant diseases: significant cardiac (for example, congestive heart failure Class III or IV) or gastrointestinal disease(for example, significant gastroparesis).
[2] Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 mg/dL (177 mol/L).
[3] Patients with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
[4] Have known hypersensitivity or allergy to Lantus or its excipients

The Estimated Number of Participants

Taiwan

80 participants
Global

891 participants