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

Diabetes Mellitus, Type 2 Clinical Trial

— GLITTER 2  

Official title:

AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE PHARMACEUTICALS INSULIN GLARGINE INJECTION TO LANTUS® IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371108
• Other study ID #: GL-GLAT2-3002
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2017
• Est. completion date: April 17, 2019

Study information

• Verified date: December 2021
• Source: Gan and Lee Pharmaceuticals, USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

8. Concomitant medications are allowed, provided that no significant dosing changes are anticipated during the study (see the exclusion criteria below for specific prohibited concomitant medications); for concomitant thyroid medications, subjects must have been on a stable dosage for 90 days before screening.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• Gan & Lee Insulin Glargine Injection
Route of administration: subcutaneous injection
• Lantus®
Route of administration: subcutaneous injection

Locations

Country	Name	City	State
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	Simon Williamson Clinic	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Meridien Research	Bradenton	Florida
United States	Burke Internal Medicine & Research	Burke	Virginia
United States	ClinSearch - Clinical Research Specialists	Chattanooga	Tennessee
United States	University Diabetes & Endocrine Consultants	Chattanooga	Tennessee
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	John H. Stroger Jr. Hospital of Cook County	Chicago	Illinois
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Endocrinology Associates, Inc.	Columbus	Ohio
United States	Midwest CRC	Crystal Lake	Illinois
United States	PriMed Clinical Research	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Stonesifer Clinical Research	Federal Way	Washington
United States	The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida
United States	Valley Research	Fresno	California
United States	Physicians East, PA	Greenville	North Carolina
United States	Mountain View Clinical Research	Greer	South Carolina
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Homestead Associates in Research	Homestead	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Clinical Investigations Specialists-Wisconsin	Kenosha	Wisconsin
United States	Sante Clinical Research	Kerrville	Texas
United States	New Phase Research & Development	Knoxville	Tennessee
United States	Palm Research Center, Inc.	Las Vegas	Nevada
United States	Kentucky Diabetes Endocrinology Center	Lexington	Kentucky
United States	L-MARC Research Center	Louisville	Kentucky
United States	Sestron Clinical Research	Marietta	Georgia
United States	ActivMed Practices and Research - Methuen	Methuen	Massachusetts
United States	Biotech Pharmaceutical Group, LLC	Miami	Florida
United States	Genoma Research Group	Miami	Florida
United States	Miami Dade Medical Research Institute, LLC	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	Radiant Research	Murray	Utah
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	The Rose Salter Medical Research Foundation	Newport Coast	California
United States	California Medical Research Association	Northridge	California
United States	Peninsula Research	Ormond Beach	Florida
United States	Oviedo Medical Research	Oviedo	Florida
United States	Family Practice Specialists	Phoenix	Arizona
United States	Rainier Clinical Research Center, Inc.	Renton	Washington
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Texas Diabetes & Endocrinology - Round Rock	Round Rock	Texas
United States	Northern California Research Corp.	Sacramento	California
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Northeast Clinical Research of San Antonio	Schertz	Texas
United States	Terence T. Hart, MD	Tuscumbia	Alabama
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Advanced Clinical Research	West Jordan	Utah
United States	Metabolic Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gan and Lee Pharmaceuticals, USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CFB in HbA1c to Week 26	Change is HbA1c value at week 26 minus the value at baseline.	Baseline to Week 26
Secondary	Immunogenicity - Percentage of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed 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.	Baseline to Week 26
Secondary	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	The percentage of subjects in each treatment group with confirmed positive AIA at baseline (n=6) who developed an important increase (at least a 4-fold increase in titers after baseline) up to visit Week 26.	Baseline to Week 26
Secondary	Immunogenicity - Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline	The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.	Baseline to Week 26
Secondary	Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline	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 neutralizing antibodies after baseline and up to visit Week 26.	Baseline to Week 26
Secondary	Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline	The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.	Baseline to Week 26
Secondary	Efficacy - Postbaseline FBG Control	The number and percentage of subjects who achieve an FBG test result of = 8.0 mmol/L (= 144.0 mg/dL) at visit Week 26.	Baseline to Week 26
Secondary	Efficacy - HbA1c Control	The number and percentage of subjects who achieve a HbA1c of < 7.0% at visit Week 26.	At Week 26