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

• Sponsor: Gan and Lee Pharmaceuticals, USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03371108
• Collaborator: (none)
• Enrollment: 567
• Locations: 57
• Arms: 2
• Actual Duration (Months): 17.5
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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®

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Biological: Gan & Lee Insulin Glargine Injection; Biological: Lantus®	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 567 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 31, 2017
• Actual Primary Completion Date: Apr 17, 2019
• Actual Study Completion Date: Apr 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Gan & Lee Insulin Glargine Injection; Route of administration: subcutaneous injection
Active Comparator: 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.	Biological: Lantus®; Route of administration: subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint [Baseline to Week 26]

   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.

Secondary Outcome Measures

1. CFB in HbA1c to Week 26 [Baseline to Week 26]

   Change is HbA1c value at week 26 minus the value at baseline.

2. Immunogenicity - Percentage of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline [Baseline to Week 26]

   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.

3. 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]

   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.

4. Immunogenicity - Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline [Baseline to Week 26]

   The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.

5. Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline [Baseline to Week 26]

   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.

6. Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline [Baseline to Week 26]

   The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.

7. Efficacy - Postbaseline FBG Control [Baseline to Week 26]

   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.

8. Efficacy - HbA1c Control [At Week 26]

   The number and percentage of subjects who achieve a HbA1c of < 7.0% at visit Week 26.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

5. 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.

6. 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.

7. HbA1c values as follows:

8. If insulin-naïve, HbA1c ≤ 11.0%.

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

10. Body mass index (BMI) ≤ 45 kg/m2.

11. 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.

12. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Simon Williamson Clinic	Birmingham	Alabama	United States	35211
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3407
3	Terence T. Hart, MD	Tuscumbia	Alabama	United States	35674
4	Family Practice Specialists	Phoenix	Arizona	United States	85018
5	Valley Research	Fresno	California	United States	93720
6	The Rose Salter Medical Research Foundation	Newport Coast	California	United States	92657
7	California Medical Research Association	Northridge	California	United States	91324
8	Northern California Research Corp.	Sacramento	California	United States	95821
9	CMR of Greater New Haven, LLC	Hamden	Connecticut	United States	06517
10	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
11	Meridien Research	Bradenton	Florida	United States	34201
12	The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida	United States	33312
13	Homestead Associates in Research	Homestead	Florida	United States	33032
14	Biotech Pharmaceutical Group, LLC	Miami	Florida	United States	33155
15	Genoma Research Group	Miami	Florida	United States	33165
16	New Horizon Research Center	Miami	Florida	United States	33175
17	Miami Dade Medical Research Institute, LLC	Miami	Florida	United States	33176
18	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
19	Peninsula Research	Ormond Beach	Florida	United States	32174
20	Oviedo Medical Research	Oviedo	Florida	United States	32765
21	Metabolic Research Institute	West Palm Beach	Florida	United States	33401
22	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
23	iResearch Atlanta	Decatur	Georgia	United States	30030
24	Sestron Clinical Research	Marietta	Georgia	United States	30060
25	Endocrine Research Solutions, Inc.	Roswell	Georgia	United States	30076
26	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
27	Cedar Crosse Research Center	Chicago	Illinois	United States	60607
28	John H. Stroger Jr. Hospital of Cook County	Chicago	Illinois	United States	60612
29	Midwest CRC	Crystal Lake	Illinois	United States	60012
30	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa	United States	50265
31	Kentucky Diabetes Endocrinology Center	Lexington	Kentucky	United States	40503-1473
32	L-MARC Research Center	Louisville	Kentucky	United States	40213
33	ActivMed Practices and Research - Methuen	Methuen	Massachusetts	United States	01844
34	Palm Research Center, Inc.	Las Vegas	Nevada	United States	89128
35	Physicians East, PA	Greenville	North Carolina	United States	27834
36	Lillestol Research LLC	Fargo	North Dakota	United States	58104
37	Endocrinology Associates, Inc.	Columbus	Ohio	United States	43201
38	Aventiv Research, Inc.	Columbus	Ohio	United States	43213-6523
39	PriMed Clinical Research	Dayton	Ohio	United States	45419
40	Mountain View Clinical Research	Greer	South Carolina	United States	29651
41	University Diabetes & Endocrine Consultants	Chattanooga	Tennessee	United States	37411
42	ClinSearch - Clinical Research Specialists	Chattanooga	Tennessee	United States	37421
43	New Phase Research & Development	Knoxville	Tennessee	United States	37909
44	Austin Regional Clinic	Austin	Texas	United States	78726
45	Texas Diabetes & Endocrinology - Central Austin	Austin	Texas	United States	78731-4309
46	Texas Diabetes & Endocrinology - South Austin	Austin	Texas	United States	78749
47	Sante Clinical Research	Kerrville	Texas	United States	78028
48	Texas Diabetes & Endocrinology - Round Rock	Round Rock	Texas	United States	78681
49	Clinical Trials of Texas	San Antonio	Texas	United States	78229
50	Northeast Clinical Research of San Antonio	Schertz	Texas	United States	78154
51	Radiant Research	Murray	Utah	United States	84123
52	Wasatch Clinical Research, LLC	Salt Lake City	Utah	United States	84107
53	Advanced Clinical Research	West Jordan	Utah	United States	84088
54	Burke Internal Medicine & Research	Burke	Virginia	United States	22105
55	Stonesifer Clinical Research	Federal Way	Washington	United States	98003
56	Rainier Clinical Research Center, Inc.	Renton	Washington	United States	98057
57	Clinical Investigations Specialists-Wisconsin	Kenosha	Wisconsin	United States	53144

Sponsors and Collaborators

• Gan and Lee Pharmaceuticals, USA

Investigators

• Study Director: Jia Lu, PhD, Gan & Lee Pharmaceuticals, USA
• Principal Investigator: Elena A. Christofides, MD, FACE, Endocrinology Research Associates, Inc.

Study Documents (Full-Text)

• Study Protocol - Apr 25, 2019
• Statistical Analysis Plan - Dec 17, 2020
• Informed Consent Form - Dec 5, 2018

More Information

Publications

None provided.

• Responsible Party: Gan and Lee Pharmaceuticals, USA
• ClinicalTrials.gov Identifier: NCT03371108
• Other Study ID Numbers: GL-GLAT2-3002
• First Posted: Dec 13, 2017
• Last Update Posted: Apr 1, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gan and Lee Pharmaceuticals, USA: Diabetes; Diabetes Type 2; Type 2; Basal; Insulin; Glargine; T2DM; Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Glargine

Study Results

Participant Flow

Recruitment Details	Reviewed and approved by each IRB.
Pre-assignment Detail	Inclusion and Exclusion Criteria.

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Period Title: Safety Analysis Set
STARTED	284	283
COMPLETED	281	282
NOT COMPLETED	3	1
Period Title: Safety Analysis Set
STARTED	281	282
COMPLETED	259	256
NOT COMPLETED	22	26

Baseline Characteristics

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®	Total
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection	Total of all reporting groups
Overall Participants	284	283	567
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	163 57.4%	178 62.9%	341 60.1%
>=65 years	121 42.6%	105 37.1%	226 39.9%
Sex: Female, Male (Count of Participants)
Female	104 36.6%	122 43.1%	226 39.9%
Male	180 63.4%	161 56.9%	341 60.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	59 20.8%	69 24.4%	128 22.6%
Not Hispanic or Latino	223 78.5%	213 75.3%	436 76.9%
Unknown or Not Reported	2 0.7%	1 0.4%	3 0.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%	1 0.4%	3 0.5%
Asian	15 5.3%	12 4.2%	27 4.8%
Native Hawaiian or Other Pacific Islander	2 0.7%	1 0.4%	3 0.5%
Black or African American	35 12.3%	36 12.7%	71 12.5%
White	227 79.9%	225 79.5%	452 79.7%
More than one race	2 0.7%	3 1.1%	5 0.9%
Unknown or Not Reported	1 0.4%	5 1.8%	6 1.1%
Region of Enrollment (Number) [Number]
United States	284 100%	283 100%	567 100%
AIA result (Count of Participants)
Negative	252 88.7%	263 92.9%	515 90.8%
Positive	5 1.8%	1 0.4%	6 1.1%
Nonreportable	27 9.5%	19 6.7%	46 8.1%
Body Mass Index (BMI) ≤45 kg/m^2 (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	33.49 (5.589)	33.59 (6.025)	33.54 (5.806)
Duration of Diabetes (Years) (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	15.2 (7.96)	15.3 (7.92)	15.3 (7.93)
HbA1c (%) (HbA1c (%)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [HbA1c (%)]	8.49 (1.027)	8.51 (1.029)	8.50 (1.027)
NAb result (Count of Participants)
Negative	5 1.8%	1 0.4%	6 1.1%
Positive	0 0%	0 0%	0 0%
Not Tested	279 98.2%	282 99.6%	561 98.9%
Thyroid Disease (Count of Participants)
Absence	243 85.6%	229 80.9%	472 83.2%
Presence	41 14.4%	54 19.1%	95 16.8%
Hypothyroidism	34 12%	45 15.9%	79 13.9%
Hyperthyroidism	2 0.7%	0 0%	2 0.4%
Structural abnormality	1 0.4%	1 0.4%	2 0.4%
Thyroid Cancer	0 0%	0 0%	0 0%
Other	4 1.4%	8 2.8%	12 2.1%
Weight (kg) (Weight (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weight (kg)]	98.011 (20.0532)	98.141 (20.5269)	98.076 (20.2732)

Outcome Measures

1. Primary Outcome

Title	Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint
Description	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.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set (SS) was comprised of all subjects whose treatment assignment was randomly assigned who received any of the study treatment, even a partial dose, and had non-missing values.

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	281	282
Number [Percentage of subjects with TI-AIA]	54	60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gan & Lee Insulin Glargine Injection, Lantus®
	Comments	This is a two-arm study.
	Type of Statistical Test	Equivalence
	Comments	The determination of equivalence was defined by the US-FDA as a confidence interval that was contained within the equivalence limits of +/- 10.7.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.1
	Confidence Interval	(2-Sided) 90%; -7.6 to 3.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.39
	Estimation Comments	The asymptotic standard error was planned and is reported above.

2. Secondary Outcome

Title	CFB in HbA1c to Week 26
Description	Change is HbA1c value at week 26 minus the value at baseline.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was comprised of all subjects whose treatment assignment was randomly assigned with non-missing baseline values.

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	284	283
Least Squares Mean (Standard Error) [Percentage of glycosylated hemoglobin]	-0.39 (0.079)	-0.45 (0.079)

3. Secondary Outcome

Title	Immunogenicity - Percentage of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline
Description	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	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

Subset of subjects whose baseline AIA was negative (n=511).

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	249	262
Count of Participants [Participants]	42 14.8%	53 18.7%

4. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

Subset of subjects in each treatment group with confirmed positive AIA at baseline (n=6).

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	5	1
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Immunogenicity - Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline
Description	The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

Subjects with Confirmed Positive Anti-Insulin Antibodies at Baseline with non-missing post-baseline AIA titer values (n=3).

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	2	1
Mean (Standard Deviation) [Titers]	23.5 (19.09)	-3.0 (NA)

6. Secondary Outcome

Title	Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline
Description	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.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

Percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	10	16
Count of Participants [Participants]	1 0.4%	3 1.1%

7. Secondary Outcome

Title	Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline
Description	The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	281	282
Count of Participants [Participants]	58 20.4%	61 21.6%

8. Secondary Outcome

Title	Efficacy - Postbaseline FBG Control
Description	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.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

FBG control (FBG ≤ 8.0 mmol/L)

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	284	283
Lack of Postbaseline FBG control	151 53.2%	145 51.2%
Sufficient Postbaseline FBG control	133 46.8%	138 48.8%

9. Secondary Outcome

Title	Efficacy - HbA1c Control
Description	The number and percentage of subjects who achieve a HbA1c of < 7.0% at visit Week 26.
Time Frame	At Week 26

Outcome Measure Data

Analysis Population Description

HbA1c control (HbA1c < 7.0%)

Arm/Group Title	Gan & Lee Insulin Glargine Injection	Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	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. Lantus®: Route of administration: subcutaneous injection
Measure Participants	284	283
Lack of Postbaseline HbA1c Control	249 87.7%	246 86.9%
Sufficient Postbaseline HbA1c Control	35 12.3%	37 13.1%

Adverse Events

Time Frame	26-weeks
Adverse Event Reporting Description	All untoward events, All-Cause Mortality, Serious, or Any Other (non-serious) Adverse Events were collected by regular investigator assessment and participants self-report, monitored, assessed, coded, and summarized.
Arm/Group Title	Gan & Lee Insulin Glargine Injection		Lantus®
Arm/Group Description	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. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection		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. Lantus®: Route of administration: subcutaneous injection
All Cause Mortality
	Gan & Lee Insulin Glargine Injection		Lantus®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/281 (0%)		0/282 (0%)
Serious Adverse Events
	Gan & Lee Insulin Glargine Injection		Lantus®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/281 (5.3%)		16/282 (5.7%)
Blood and lymphatic system disorders
B-cell small lymphocytic lymphoma	0/281 (0%)	0	1/282 (0.4%)	1
Cardiac disorders
Cardiac failure congestive	1/281 (0.4%)	1	0/282 (0%)	0
Cardiomyopathy	0/281 (0%)	0	1/282 (0.4%)	1
Carotid artery aneurysm	0/281 (0%)	0	1/282 (0.4%)	1
Silent myocardial infarction	0/281 (0%)	0	1/282 (0.4%)	1
Endocrine disorders
Pancreatic carcinoma	1/281 (0.4%)	1	0/282 (0%)	0
Pancreatitis acute	1/281 (0.4%)	1	0/282 (0%)	0
Gastrointestinal disorders
Gastrointestinal haemorrhage	0/281 (0%)	0	1/282 (0.4%)	1
Lactic acidosis	0/281 (0%)	0	1/282 (0.4%)	1
Rectal haemorrhage	0/281 (0%)	0	1/282 (0.4%)	1
General disorders
Chest Pain	2/281 (0.7%)	2	0/282 (0%)	0
Non-cardiac chest pain	1/281 (0.4%)	1	1/282 (0.4%)	1
Angina pectoris	0/281 (0%)	0	1/282 (0.4%)	1
Angina unstable	1/281 (0.4%)	1	0/282 (0%)	0
Back pain	1/281 (0.4%)	1	0/282 (0%)	0
Fall	1/281 (0.4%)	1	0/282 (0%)	0
Hypertensive emergency	0/281 (0%)	0	1/282 (0.4%)	1
Localised infection	0/281 (0%)	0	1/282 (0.4%)	1
Infections and infestations
Osteomyelitis	2/281 (0.7%)	2	1/282 (0.4%)	1
Infection	0/281 (0%)	0	1/282 (0.4%)	1
Wound infection	0/281 (0%)	0	1/282 (0.4%)	1
Metabolism and nutrition disorders
Hypoglycemia	0/281 (0%)	0	0/282 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	1/281 (0.4%)	1	0/282 (0%)	0
Chronic lymphocytic leukaemia	0/281 (0%)	0	1/282 (0.4%)	1
Intervertebral disc protrusion	0/281 (0%)	0	1/282 (0.4%)	1
Osteoarthritis	1/281 (0.4%)	1	0/282 (0%)	0
Spondylolisthesis	1/281 (0.4%)	1	0/282 (0%)	0
Vertebral foraminal stenosis	1/281 (0.4%)	1	0/282 (0%)	0
Nervous system disorders
Syncope	2/281 (0.7%)	2	0/282 (0%)	0
Transient ischaemic attack	0/281 (0%)	0	1/282 (0.4%)	1
Renal and urinary disorders
Renal cell carcinoma	0/281 (0%)	0	1/282 (0.4%)	1
Skin and subcutaneous tissue disorders
Skin ulcer	2/281 (0.7%)	2	0/282 (0%)	0
Cellulitis	1/281 (0.4%)	1	0/282 (0%)	0
Other (Not Including Serious) Adverse Events
	Gan & Lee Insulin Glargine Injection		Lantus®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	125/281 (44.5%)		122/282 (43.3%)
General disorders
Fatigue	0/281 (0%)	0	1/282 (0.4%)	1
Hunger	0/281 (0%)	0	1/282 (0.4%)	1
Injection related	1/281 (0.4%)	1	0/282 (0%)	0
Other	1/281 (0.4%)	1	0/282 (0%)	0
Investigations
Weight Increased	0/281 (0%)	0	3/282 (1.1%)	3
Metabolism and nutrition disorders
Hypoglycemia	120/281 (42.7%)	831	117/282 (41.5%)	761
Nervous system disorders
Headache	2/281 (0.7%)	2	1/282 (0.4%)	1
Dizziness	1/281 (0.4%)	1	0/282 (0%)	0
Gastroenteritis	0/281 (0%)	0	1/282 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.