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

NCT03371108 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GL-GLAT2-3002
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 57

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

Keywords

Diabetes; Diabetes Type 2; Type 2; Basal; Insulin; Glargine; T2DM; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint

  Subjects were classified as experiencing a TI-AIA or not. A TI-AIA is defined as a subject experiencing a newly confirmed positive AIA status, if they were negative at baseline or a 4-fold increase in their titer values if they were positive. The primary outcome measure is summarized as the percent of subjects experiencing a TI-AIA in the group.

  Baseline to Week 26

Secondary Outcomes (8)

• CFB in HbA1c to Week 26

  Baseline to Week 26

• Immunogenicity - Percentage of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline

  Baseline to Week 26

• Immunogenicity - Percentage of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline Who Developed at Least a 4-fold Increase in Titers After Baseline

  Baseline to Week 26

• Immunogenicity - Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline

  Baseline to Week 26

• Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline

  Baseline to Week 26

Study Arms (2)

Gan & Lee Insulin Glargine Injection

EXPERIMENTAL

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.

Biological: Gan & Lee Insulin Glargine Injection

Lantus®

ACTIVE COMPARATOR

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.

Biological: Lantus®

Interventions

Gan & Lee Insulin Glargine Injection BIOLOGICAL

Route of administration: subcutaneous injection

Gan & Lee Insulin Glargine Injection

Lantus® BIOLOGICAL

Route of administration: subcutaneous injection

Lantus®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive.
• 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.
• Ability to understand and fully comply with all study procedures and restrictions.
• Subjects with a confirmed diagnosis of type 2 diabetes mellitus who meet one of the following:
• 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.
• 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.
• HbA1c values as follows:
• If insulin-naïve, HbA1c ≤ 11.0%.
• If previously on a basal insulin regimen, HbA1c ≥ 7.0% and ≤ 11.0%.
• Body mass index (BMI) ≤ 45 kg/m2.
• 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.

You may not qualify if:

• Participation in another clinical study or use of any study drug within 30 days before screening.
• Previous use of a biosimilar insulin, either basal or bolus.
• Diabetic ketoacidosis within a year before screening.
• 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).
• 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.
• 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).
• Inadequately controlled thyroid disease, defined as a TSH or free T4 value \> the upper limit of normal.
• BMI \> 45 kg/m2.
• 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).
• Documented history of anti-insulin antibodies.
• 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).
• Current use of medication intended to cause weight loss or weight gain.
• Alcohol or substance use disorder within the 2 years before screening.
• Any previous or anticipated treatment with interferons.
• Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (57)

Simon Williamson Clinic

Birmingham, Alabama, 35211, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3407, United States

Location

Terence T. Hart, MD

Tuscumbia, Alabama, 35674, United States

Location

Family Practice Specialists

Phoenix, Arizona, 85018, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

The Rose Salter Medical Research Foundation

Newport Coast, California, 92657, United States

Location

California Medical Research Association

Northridge, California, 91324, United States

Location

Northern California Research Corp.

Sacramento, California, 95821, United States

Location

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Meridien Research

Bradenton, Florida, 34201, United States

Location

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, 33312, United States

Location

Homestead Associates in Research

Homestead, Florida, 33032, United States

Location

Biotech Pharmaceutical Group, LLC

Miami, Florida, 33155, United States

Location

Genoma Research Group

Miami, Florida, 33165, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Peninsula Research

Ormond Beach, Florida, 32174, United States

Location

Oviedo Medical Research

Oviedo, Florida, 32765, United States

Location

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Sestron Clinical Research

Marietta, Georgia, 30060, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Midwest CRC

Crystal Lake, Illinois, 60012, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503-1473, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

ActivMed Practices and Research - Methuen

Methuen, Massachusetts, 01844, United States

Location

Palm Research Center, Inc.

Las Vegas, Nevada, 89128, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Endocrinology Associates, Inc.

Columbus, Ohio, 43201, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213-6523, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

Mountain View Clinical Research

Greer, South Carolina, 29651, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

ClinSearch - Clinical Research Specialists

Chattanooga, Tennessee, 37421, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Austin Regional Clinic

Austin, Texas, 78726, United States

Location

Texas Diabetes & Endocrinology - Central Austin

Austin, Texas, 78731-4309, United States

Location

Texas Diabetes & Endocrinology - South Austin

Austin, Texas, 78749, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Texas Diabetes & Endocrinology - Round Rock

Round Rock, Texas, 78681, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Northeast Clinical Research of San Antonio

Schertz, Texas, 78154, United States

Location

Radiant Research

Murray, Utah, 84123, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Burke Internal Medicine & Research

Burke, Virginia, 22105, United States

Location

Stonesifer Clinical Research

Federal Way, Washington, 98003, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

Clinical Investigations Specialists-Wisconsin

Kenosha, Wisconsin, 53144, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

gallium nitrate; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jia Lu, MD, PhD Executive Director of US Clinical Sciences
• Organization: Gan & Lee Pharmaceuticals USA Corp.

Jia.Lu@ganlee.us

+1 888-288-5395

Study Officials

• Jia Lu, PhD

  Gan & Lee Pharmaceuticals, USA

  STUDY DIRECTOR

• Elena A. Christofides, MD, FACE

  Endocrinology Research Associates, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who meet the study eligibility criteria will be centrally randomized 1:1 in an open-label fashion to receive either Gan \& Lee Insulin Glargine Injection or Lantus® for 26 weeks.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 13, 2017
• Study Start: October 31, 2017
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: April 1, 2022
• Results First Posted: March 23, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (57)