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Insulin
Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro (GENTL 1 Trial)
Phase 3
Waitlist Available
Research Sponsored by Gan and Lee Pharmaceuticals, USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 to week 26
Awards & highlights
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Summary
Primary Objective: • To compare the immunogenicity of Gan \& Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: * To evaluate the safety of Gan \& Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM * To evaluate the efficacy of Gan \& Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM
Eligible Conditions
- Diabetes
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 to week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment developed AIAs or important increase in AIA titers
Secondary study objectives
Change from baseline in HbA1c at visit Week 26
Incidence and severity of all treatment-emergent adverse events
Mean change from baseline in AIA titers
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Gan & Lee Insulin Lispro InjectionExperimental Treatment1 Intervention
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.
Group II: Active Comparator: HumalogActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin lispro
FDA approved
Find a Location
Who is running the clinical trial?
Gan and Lee Pharmaceuticals, USALead Sponsor
26 Previous Clinical Trials
3,227 Total Patients Enrolled
3 Trials studying Diabetes
95 Patients Enrolled for Diabetes
Jia Lu, PhDStudy DirectorGan & Lee Pharmaceuticals, USA
3 Previous Clinical Trials
717 Total Patients Enrolled