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Clinical Trials List

Protocol NumberI8B-MC-ITRM
NCT Number(ClinicalTrials.gov Identfier)NCT03214367

2017-08-01 - 2020-05-31

Phase III

Terminated6

Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro with an Open-Label Postprandial LY900014 Treatment Group, in Combination with Insulin Glargine or Insulin Degludec, in Adults with Type 1 Diabetes PRONTO-T1D.

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • 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 林世鐸 Division of Endocrinology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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 Chung-Hsing Wang Division of Pediatrics
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Horng-Yih Ou Division of Endocrinology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

10 Stop recruiting

Condition/Disease

Type 1 Diabetes Mellitus

Objectives

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

Test Drug

LY900014

Active Ingredient

LY900014

Dosage Form

Injection pen

Dosage

100U/mg

Endpoints

Primary Outcome Measures:
1. Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26.

Secondary Outcome Measures :
1. Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26.
2. Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26.
3. Rate of Severe Hypoglycemia at Week 26.
4. Rate of Documented Symptomatic Hypoglycemia at Week 26.
5. Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26.
6. Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26.
7. Change From Baseline in Insulin Dose at Week 26.
8. Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26.
9. Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26.
10. Percentage of Participants With HbA1c <7%.
11. Change From Baseline in HbA1c at Week 52.

Inclution Criteria

1. Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
2. HbA1c of ≥7.0 and ≤9.5%.
3. Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
4. Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.

Exclusion Criteria

1. Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
2. Have had more than 1 severe hypoglycemic episode within 6 months of screening.
3. Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
4. Have clinically significant gastrointestinal disease.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    1109 participants

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