Trial Outcomes & Findings for Gan & Lee Insulin Glargine Target Type (1) Evaluating Research (NCT NCT03371082)

NCT ID: NCT03371082

Last Updated: 2024-05-14

Results Overview

TI-AIA is the Composite of Newly Confirmed Positive AIA or Important-Increase in AIA titer

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

576 participants

Primary outcome timeframe

Assessed up to Week 26

Results posted on

2024-05-14

Participant Flow

Reviewed and approved by each IRB.

Participant milestones

Participant milestones
Measure	Gan & Lee Insulin Glargine Injection Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Overall Study STARTED	287	289
Overall Study COMPLETED	258	255
Overall Study NOT COMPLETED	29	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gan & Lee Insulin Glargine Target Type (1) Evaluating Research

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gan & Lee Insulin Glargine Injection n=287 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection	Total n=576 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	256 Participants n=5 Participants	252 Participants n=7 Participants	508 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants	37 Participants n=7 Participants	68 Participants n=5 Participants
Age, Continuous	45.7 Years STANDARD_DEVIATION 13.96 • n=5 Participants	46.7 Years STANDARD_DEVIATION 14.46 • n=7 Participants	46.2 Years STANDARD_DEVIATION 14.21 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	112 Participants n=7 Participants	215 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants	177 Participants n=7 Participants	361 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	259 Participants n=5 Participants	272 Participants n=7 Participants	531 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	262 Participants n=5 Participants	265 Participants n=7 Participants	527 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Hungary	20 participants n=5 Participants	21 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants	150 participants n=7 Participants	301 participants n=5 Participants
Region of Enrollment Czechia	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants
Region of Enrollment Poland	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants
Region of Enrollment Germany	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment Spain	26 participants n=5 Participants	28 participants n=7 Participants	54 participants n=5 Participants
Anti-Insulin Antibodies (AIA) Negative	236 Participants n=5 Participants	239 Participants n=7 Participants	475 Participants n=5 Participants
Anti-Insulin Antibodies (AIA) Positive	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Anti-Insulin Antibodies (AIA) Nonreportable	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Insulin Antibodies (AIA) Missing	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Body Mass Index (BMI)	27.01 kg/m2 STANDARD_DEVIATION 3.875 • n=5 Participants	27.11 kg/m2 STANDARD_DEVIATION 4.237 • n=7 Participants	27.06 kg/m2 STANDARD_DEVIATION 4.058 • n=5 Participants
Duration of Diabetes	20.2 Years STANDARD_DEVIATION 13.88 • n=5 Participants	21.7 Years STANDARD_DEVIATION 13.95 • n=7 Participants	21.0 Years STANDARD_DEVIATION 13.92 • n=5 Participants
Glycosylated Hemoglobin (HbA1c)	8.11 HbA1c (%) STANDARD_DEVIATION 1.229 • n=5 Participants	8.08 HbA1c (%) STANDARD_DEVIATION 1.267 • n=7 Participants	8.10 HbA1c (%) STANDARD_DEVIATION 1.247 • n=5 Participants
Anti-Insulin Neutralizing Antibodies (NAbs) Negative	44 Participants n=5 Participants	38 Participants n=7 Participants	82 Participants n=5 Participants
Anti-Insulin Neutralizing Antibodies (NAbs) Positive	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Anti-Insulin Neutralizing Antibodies (NAbs) Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Insulin Neutralizing Antibodies (NAbs) Not Tested	236 Participants n=5 Participants	241 Participants n=7 Participants	477 Participants n=5 Participants
Thyroid Disease Absence	243 Participants n=5 Participants	210 Participants n=7 Participants	453 Participants n=5 Participants
Thyroid Disease Presence	44 Participants n=5 Participants	79 Participants n=7 Participants	123 Participants n=5 Participants
Thyroid Disease Hypothyroidism	32 Participants n=5 Participants	52 Participants n=7 Participants	84 Participants n=5 Participants
Thyroid Disease Hyperthyroidism	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Thyroid Disease Structural abnormality	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Thyroid Disease Thyroid Cancer	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Thyroid Disease Other	6 Participants n=5 Participants	18 Participants n=7 Participants	24 Participants n=5 Participants
Weight	80.901 kg STANDARD_DEVIATION 13.4277 • n=5 Participants	81.548 kg STANDARD_DEVIATION 16.3993 • n=7 Participants	81.226 kg STANDARD_DEVIATION 14.9829 • n=5 Participants

PRIMARY outcome

Timeframe: Assessed up to Week 26

Population: 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.

TI-AIA is the Composite of Newly Confirmed Positive AIA or Important-Increase in AIA titer

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=287 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Treatment-induced Anti-Insulin Antibody (TI-AIA)	4.8 Titers Standard Deviation 88.88	42.5 Titers Standard Deviation 332.90

SECONDARY outcome

Timeframe: Assessed up to Week 26

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

The change between baseline (CFB) in HbA1c and at 26 weeks

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=287 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Glycosylated Hemoglobin HbA1c	-0.08 Percent of total hemoglobin Standard Error 0.072	0.00 Percent of total hemoglobin Standard Error 0.061

SECONDARY outcome

Timeframe: Assessed up to Week 26

Population: Subset of subjects whose baseline AIA was negative (n=475).

The number of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26.

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=236 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=239 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline	63 Participants	59 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Subset of subjects whose baseline AIA was confirmed positive (n=97).

The number of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to 26 weeks.

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=49 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=48 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline.	11 Participants	14 Participants

SECONDARY outcome

Timeframe: Assessed up to Week 26

Population: Subjects with Confirmed Positive Anti-Insulin Antibodies at Baseline with non-missing AIA titer values.

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

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=29 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=30 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline	4.8 Titers Standard Deviation 88.88	-42.5 Titers Standard Deviation 332.90

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Analysis Set - Subjects with Confirmed Positive AIA after Baseline.

The number 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.

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=54 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=60 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline.	13 Participants	16 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Analysis Set.

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

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=287 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Number of Subjects With Confirmed Positive AIA After Baseline.	102 Participants	103 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: FBG control (FBG ≤ 6.0 mmol/L).

The number of subjects who achieve an FBG test result of ≤ 6.0 mmol/L at visit Week 26.

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=287 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Postbaseline FBG Control Lack of Postbaseline FBG control	248 Participants	247 Participants
Postbaseline FBG Control Sufficient Postbaseline FBG control	39 Participants	42 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: HbA1c control (HbA1c \< 7.0%).

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

Outcome measures

Outcome measures
Measure	Gan & Lee Insulin Glargine Injection n=287 Participants Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 Participants Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
HbA1c Control. Lack of Postbaseline HbA1c Control	241 Participants	245 Participants
HbA1c Control. Sufficient Postbaseline HbA1c Control	46 Participants	44 Participants

Adverse Events

Gan & Lee Insulin Glargine Injection

Serious events: 10 serious events

Other events: 160 other events

Deaths: 0 deaths

Lantus®

Serious events: 14 serious events

Other events: 161 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Gan & Lee Insulin Glargine Injection n=287 participants at risk Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 participants at risk Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Metabolism and nutrition disorders Hypoglycemia	55.1% 158/287 • Number of events 3476 • 26-weeks 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.	55.7% 161/289 • Number of events 2936 • 26-weeks 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.
Investigations Weight increase	1.0% 3/287 • Number of events 3 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
General disorders Fatigue	1.0% 3/287 • Number of events 3 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Metabolism and nutrition disorders Hyperglycemia	0.70% 2/287 • Number of events 4 • 26-weeks 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.	0.35% 1/289 • Number of events 3 • 26-weeks 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.
Metabolism and nutrition disorders Blood creatine phosphokinase increased	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
General disorders Contusion	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Metabolism and nutrition disorders Diabetes mellitus	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Nervous system disorders Dizziness	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Skin and subcutaneous tissue disorders Face oedema	0.35% 1/287 • Number of events 2 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Foot Fracture	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Skin and subcutaneous tissue disorders Herpes zoster	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Skin and subcutaneous tissue disorders Skin disorder	0.35% 1/287 • Number of events 2 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.

Additional Information

Jia Lu, MD, PhD Executive Director of US Clinical Sciences

Gan & Lee Pharmaceuticals USA Corp.

Phone: +1 888-288-5395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Gan & Lee Insulin Glargine Injection n=287 participants at risk Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled 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® n=289 participants at risk Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
Metabolism and nutrition disorders Hypoglycemia	1.0% 3/287 • Number of events 20 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Renal and urinary disorders Acute kidney injury	0.00% 0/287 • 26-weeks 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.	0.69% 2/289 • Number of events 2 • 26-weeks 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.
Psychiatric disorders Depression	0.00% 0/287 • 26-weeks 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.	0.69% 2/289 • Number of events 2 • 26-weeks 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.
Metabolism and nutrition disorders Appendicitis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Benign neoplasm of spinal cord	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Blood and lymphatic system disorders Carotid artery occlusion	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Skin and subcutaneous tissue disorders Cellulitis	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Vascular disorders Cerebrovascular accident	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
General disorders Cough	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Nervous system disorders Craniocerebral injury	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Metabolism and nutrition disorders Diabetic foot	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Blood and lymphatic system disorders Diabetic ketoacidosis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Cardiac disorders Endocarditis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Infections and infestations Gangrene	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Inguinal Hernia	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Infections and infestations Localised infection	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Lower limb fracture	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Lumbar vertebral fracture	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Osteomyelitis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Vascular disorders Peripheral ischemia	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Gastrointestinal disorders Peritonitis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
General disorders Post procedural infection	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Skin and subcutaneous tissue disorders Prurigo	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Rib fracture	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Infections and infestations Sepsis	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 2 • 26-weeks 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.
General disorders Septic shock	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
Psychiatric disorders Suicidal ideation	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.
General disorders Thrombosis	0.35% 1/287 • Number of events 1 • 26-weeks 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.	0.00% 0/289 • 26-weeks 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.
Musculoskeletal and connective tissue disorders Tibia fracture	0.00% 0/287 • 26-weeks 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.	0.35% 1/289 • Number of events 1 • 26-weeks 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.