A Phase 3 interventional study of Gan & Lee Insulin Lispro Injection and Humalog in Diabetes Mellitus, Type 1, sponsored by Gan and Lee Pharmaceuticals, USA. Withdrawn at 107 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Gan and Lee Pharmaceuticals, USA · Phase 3, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
Browse Diabetes Mellitus studies →Gan and Lee Pharmaceuticals, USA is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gan \& Lee Insulin Lispro Injection for subcutaneous injection, 100 U/mL, in a disposable multidose pen injector with a pre-filled 3-mL type I glass cartridge. Subjects randomized to the Gan \& Lee Insulin Lispro Injection group will participate in the study for 26 weeks.
Biological: Gan & Lee Insulin Lispro Injection
EU-authorized Humalog KwikPen® - insulin lispro injection, solution for subcutaneous injection, 100 U/mL (pre-filled). Subjects randomized to the Humalog group will participate in the study for 26 weeks.
Biological: Humalog
Route of administration: subcutaneous injection
Route of administration: subcutaneous injection
Treatment developed AIAs or important increase in AIA titers
The percentage of subjects in each treatment group who develop treatment induced AIAs, defined as newly confirmed positive AIA development or important (at least a 4-fold) increase in titers after baseline and up to visit Week 26.
Time frame: Week 1 to Week 26
Percentage of subjects with negative AIA at baseline who develop positive AIA after baseline
The percentage of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26.
Time frame: Week 1 to Week 26
Percentage of subjects with important increase in titers
The percentage of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to visit Week 26.
Time frame: Week 1 to Week 26
Mean change from baseline in AIA titers
The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.
Time frame: Week 1 to Week 26
Percentage of subjects with confirmed positive AIA who develop anti-insulin NAbs
The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin NAbs after baseline and up to visit Week 26.
Time frame: Week 1 to Week 26
Percentage of subjects with positive AIA after baseline
The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.
Time frame: Week 1 to Week 26
Incidence and severity of all treatment-emergent adverse events
The incidence and severity of all treatment-emergent adverse events and the following subgroups: Adverse events of special interest. Serious adverse events, including fatal events. Adverse events leading to termination of the study treatment and/or early withdrawal from the study. Treatment-related adverse events. IP device-related adverse events. Injection site reactions. The incidence of clinically significant laboratory abnormalities. The incidence of clinically significant abnormalities in physical examination and vital signs.
Time frame: Week 1 to Week 26
Change from baseline in HbA1c at visit Week 26
Change from baseline in HbA1c at visit Week 26 in each treatment group.
Time frame: Week 1 to Week 26
Percentage of subjects who achieve an HbA1c of ≤ 7.0% at visit Week 26
The number and percentage of subjects who achieve an HbA1c of ≤ 7.0% at visit Week 26 in each treatment group.
Time frame: Week 1 to Week 26
Showing the first 100 of 107 sites across 6 countries.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Gan and Lee Pharmaceuticals, USA