Gan & Lee Insulin Glargine Target Type (2) Evaluating Research

NCT ID: NCT03371108

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 567 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2019-04-17

Brief Summary

Primary Objective:

• To evaluate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity

Secondary Objective:

Immunogenicity:

• To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and the percentage of subjects in each treatment group with confirmed positive AIA up to visit Week 26

Safety:

• To evaluate the safety of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®

Efficacy:

• To evaluate the efficacy of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gan & Lee Insulin Glargine Injection

Gan \& Lee Insulin Glargine Injection solution for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0 mL prefilled Gan \& Lee injector pen. Subjects randomized to the Gan \& Lee Insulin Glargine Injection group will participate in the study for 26 weeks.

Group Type: EXPERIMENTAL

Gan & Lee Insulin Glargine Injection

Intervention Type: BIOLOGICAL

Route of administration: subcutaneous injection

Lantus®

Lantus® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.

Group Type: ACTIVE_COMPARATOR

Lantus®

Intervention Type: BIOLOGICAL

Route of administration: subcutaneous injection

Interventions

Gan & Lee Insulin Glargine Injection

Route of administration: subcutaneous injection

Intervention Type: BIOLOGICAL

Lantus®

Route of administration: subcutaneous injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive.

2. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study related procedures.

3. Ability to understand and fully comply with all study procedures and restrictions.

4. Subjects with a confirmed diagnosis of type 2 diabetes mellitus who meet one of the following:

1. If insulin-naïve, subjects should have been on at least 2 approved OAMs for at least 12 weeks before screening, and the clinician has decided to add insulin therapy.

2. If already being treated with a basal and/or bolus insulin, subjects should have been treated with insulin for at least 6 months in addition to at least 1 approved OAM, and must not have changed the type or brand of insulin within 6 months prior to screening.

5. HbA1c values as follows:

1. If insulin-naïve, HbA1c ≤ 11.0%.

2. If previously on a basal insulin regimen, HbA1c ≥ 7.0% and ≤ 11.0%.

6. Body mass index (BMI) ≤ 45 kg/m2.

7. Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study.

Exclusion Criteria

1. Participation in another clinical study or use of any study drug within 30 days before screening.

2. Previous use of a biosimilar insulin, either basal or bolus.

3. Diabetic ketoacidosis within a year before screening.

4. Brittle type 2 diabetes mellitus within the year before screening (e.g., multiple hospitalizations related to diabetes mellitus and/or severe hypoglycemia for which the subject required 3rd party assistance).

5. Any severe, delayed sequela of diabetes mellitus, e.g., worsening end-stage renal disease, advanced coronary artery disease, or myocardial infarction within the year before screening, or autonomic peristaltic problems, e.g., gastroparesis.

6. Anticipated change in insulin used during the study (change in dosage is allowed, but change in type or brand of insulin will result in the subject being withdrawn from the study).

7. Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal.

8. BMI > 45 kg/m2.

9. Any clinically significant (in the opinion of the Investigator) hematology or chemistry test results at screening, including any liver function test > 3x the upper limit of normal (subjects with elevated bilirubin due to Gilbert syndrome are eligible to participate).

10. Documented history of anti-insulin antibodies.

11. Treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents within 60 days before screening (newly-prescribed or high-dose corticosteroids are prohibited; chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage are allowed if no increase in dose is anticipated during the study; See Appendix 3 [Section 17.3] for a list of allowed and prohibited concomitant medications).

12. Current use of medication intended to cause weight loss or weight gain.

13. Alcohol or substance use disorder within the 2 years before screening.

14. Any previous or anticipated treatment with interferons.

15. Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma.

16. Severe concomitant physical or psychiatric diseases or conditions.

17. A history of a positive test result for HIV, hepatitis B, or hepatitis C; any subject who has a positive test result during the study may continue at the discretion of the Investigator.

18. Any history of pancreatitis or pancreatectomy.

19. Any diagnosis or condition that requires the subject to undergo procedures that could decrease antibodies in plasma or that would require treatment with immunosuppressant agents.

20. Any condition e.g., splenectomy, autoimmune disease, or rheumatologic disease, that could affect immunologic responses, could indicate an altered immune system, or could require treatment with a prohibited medication.

21. Any unresolved infection or a history of active infection within 30 days before screening other than mild or viral illness (as judged by the Investigator).

22. Any other disease or condition that in the opinion of the Investigator could confound the study results or limit the subject's ability to participate in the study or comply with follow-up procedures; or any other factor that would indicate a significant risk of loss to follow up.

23. Intolerance or history of hypersensitivity to insulin glargine or any excipient of IP.

24. Inability or unwillingness to wear the CGM sensor as required for the study, or to comply with the concomitant medication requirements in the FreeStyle Libre Pro Indications and Important Safety Information, during the CGM periods.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Lu, PhD

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals, USA

Elena A. Christofides, MD, FACE

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Research Associates, Inc.

Locations

Simon Williamson Clinic

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Terence T. Hart, MD

Tuscumbia, Alabama, United States

Family Practice Specialists

Phoenix, Arizona, United States

Valley Research

Fresno, California, United States

The Rose Salter Medical Research Foundation

Newport Coast, California, United States

California Medical Research Association

Northridge, California, United States

Northern California Research Corp.

Sacramento, California, United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Meridien Research

Bradenton, Florida, United States

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, United States

Homestead Associates in Research

Homestead, Florida, United States

Biotech Pharmaceutical Group, LLC

Miami, Florida, United States

Genoma Research Group

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Peninsula Research

Ormond Beach, Florida, United States

Oviedo Medical Research

Oviedo, Florida, United States

Metabolic Research Institute

West Palm Beach, Florida, United States

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States

iResearch Atlanta

Decatur, Georgia, United States

Sestron Clinical Research

Marietta, Georgia, United States

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Cedar Crosse Research Center

Chicago, Illinois, United States

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Midwest CRC

Crystal Lake, Illinois, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, United States

L-MARC Research Center

Louisville, Kentucky, United States

ActivMed Practices and Research - Methuen

Methuen, Massachusetts, United States

Palm Research Center, Inc.

Las Vegas, Nevada, United States

Physicians East, PA

Greenville, North Carolina, United States

Lillestol Research LLC

Fargo, North Dakota, United States

Endocrinology Associates, Inc.

Columbus, Ohio, United States

Aventiv Research, Inc.

Columbus, Ohio, United States

PriMed Clinical Research

Dayton, Ohio, United States

Mountain View Clinical Research

Greer, South Carolina, United States

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, United States

ClinSearch - Clinical Research Specialists

Chattanooga, Tennessee, United States

New Phase Research & Development

Knoxville, Tennessee, United States

Austin Regional Clinic

Austin, Texas, United States

Texas Diabetes & Endocrinology - Central Austin

Austin, Texas, United States

Texas Diabetes & Endocrinology - South Austin

Austin, Texas, United States

Sante Clinical Research

Kerrville, Texas, United States

Texas Diabetes & Endocrinology - Round Rock

Round Rock, Texas, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Northeast Clinical Research of San Antonio

Schertz, Texas, United States

Radiant Research

Murray, Utah, United States

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

Advanced Clinical Research

West Jordan, Utah, United States

Burke Internal Medicine & Research

Burke, Virginia, United States

Stonesifer Clinical Research

Federal Way, Washington, United States

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Clinical Investigations Specialists-Wisconsin

Kenosha, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GL-GLAT2-3002

Identifier Type: -

Identifier Source: org_study_id