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Protocol NumberH9X-MC-GBDD

2010-08-01 - 2014-01-31

Phase III

Terminated4

Study ended1

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

LY2189265 compares with insulin Glargine and the combined use of insulin Lispro on the treatment to target of type 2 diabetes (AWARD-4: Evaluation of the weekly use of LY2189265 in patients with type 2 diabetes. 4 [Assessment of Weekly AdministRation of LY2189265 in Diabetes-4]

  • 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 田凱仁 Division of Endocrinology
Chi Mei Medical Center

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

Principal Investigator 馬文雅 Division of Endocrinology
Cardinal Tien Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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 Study ended

Condition/Disease

Type 2 diabetes

Objectives

The main goal of this trial is to compare the control of glycosylated hemoglobin after a weekly subcutaneous injection of 1.5 mg of LY2189265 or insulin glargine (standard treatment) for 26 weeks in patients with type 2 diabetes who have been treated with meal-based insulin lispro. (HbA1c) (change from the reference point) curative effect. If the upper limit of the two-tailed 95% confidence interval (CI) of the difference between LY2189265 and insulin glargine is less than the non-inferiority limit (0.4%), it shows that LY2189265 1.5 mg has non-inferiority compared with insulin glargine in controlling HbA1c .

Test Drug

LY2189265

Active Ingredient

LY2189265 Injection, is composed of LY2189265 and the inactive

Dosage Form

syringe

Dosage

0.75
1.5

Endpoints

Changes in HbA1c; 8 SMBG values ​​(the actual value at a predetermined time point and its change from the reference point); fasting blood glucose (BG) (the actual value at a predetermined time point and its change from the reference point); The proportion of patients who achieve HbA1c ≤ 7%, <7% and ≤ 6.5% at the scheduled time; the absolute daily dose of insulin; the total daily dose of insulin glargine and the total daily dose of insulin lispro; the relative weight and BMI at the scheduled time Changes in the baseline; and HbA1c reaches ≤ 7.0%, and there is no symptomatic nocturnal hypoglycemia, it is confirmed that there is no plasma blood glucose reading ≤ 70 mg/dL (3.9 mmol/L), or meets the diagnostic criteria for severe hypoglycemia Percentage of patients.
safety:
Weight changes; episodes of hypoglycemia; hyperglycemia; hypoglycemia or hyperglycemia events requiring interventional therapy; vital signs; laboratory analysis; ECG parameters; immune enhancement specimens (antibodies against LY2189265); withdrawal; TEAEs; BMI changes ; Vital signs (blood pressure and pulse); blood lipid parameters; identification of all fatal and non-fatal cardiovascular events; identification of gastrointestinal (GI) events that may be related to pancreatitis; and thyroid monitoring.
Health results:
Patient self-report results (PRO): EuroQol 5-Dimensional Quality of Life Scale (EQ-5D), the influence of body weight on activities of daily living (IW-ADL), the influence of body weight on self-perception (IW-SP), hypoglycemia survey ( LBSS).

Inclution Criteria

Patients diagnosed with type 2 diabetes, HbA1c >7% at the time of screening, and have received the following treatments for less than 10 years: [a] basal insulin alone, or combined with oral hypoglycemic drugs (OAMs); or [b] alone Two-dose basic/rapid infusion insulin combination therapy (such as Humulin® N plus Humulin® R), or combined with OAMs; or [c] single use of basic/rapid infusion insulin fixed combination therapy (such as Humalog® Mix 75/25) ™), or with OAMs.

Exclusion Criteria

X

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    1290 participants

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