Trial Outcomes & Findings for Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (NCT NCT03371108)
NCT ID: NCT03371108
Last Updated: 2022-04-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
567 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2022-04-01
Participant Flow
Reviewed and approved by each IRB.
Inclusion and Exclusion Criteria.
Participant milestones
| Measure |
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.
Gan \& Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
|
Lantus®
Lantus® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.
Lantus®: Route of administration: subcutaneous injection
|
|---|---|---|
|
Safety Analysis Set
STARTED
|
284
|
283
|
|
Safety Analysis Set
COMPLETED
|
281
|
282
|
|
Safety Analysis Set
NOT COMPLETED
|
3
|
1
|
|
Completers
STARTED
|
281
|
282
|
|
Completers
COMPLETED
|
259
|
256
|
|
Completers
NOT COMPLETED
|
22
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
Baseline characteristics by cohort
| Measure |
Gan & Lee Insulin Glargine Injection
n=284 Participants
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®
n=283 Participants
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
n=567 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
|
163 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
121 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
223 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
227 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
284 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
567 Participants
n=5 Participants
|
|
AIA result
Negative
|
252 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
515 Participants
n=5 Participants
|
|
AIA result
Positive
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
AIA result
Nonreportable
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Body Mass Index (BMI) ≤45 kg/m^2
|
33.49 kg/m2
STANDARD_DEVIATION 5.589 • n=5 Participants
|
33.59 kg/m2
STANDARD_DEVIATION 6.025 • n=7 Participants
|
33.54 kg/m2
STANDARD_DEVIATION 5.806 • n=5 Participants
|
|
Duration of Diabetes (Years)
|
15.2 Years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
15.3 Years
STANDARD_DEVIATION 7.92 • n=7 Participants
|
15.3 Years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
|
HbA1c (%)
|
8.49 HbA1c (%)
STANDARD_DEVIATION 1.027 • n=5 Participants
|
8.51 HbA1c (%)
STANDARD_DEVIATION 1.029 • n=7 Participants
|
8.50 HbA1c (%)
STANDARD_DEVIATION 1.027 • n=5 Participants
|
|
NAb result
Negative
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
NAb result
Positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
NAb result
Not Tested
|
279 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
561 Participants
n=5 Participants
|
|
Thyroid Disease
Absence
|
243 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
472 Participants
n=5 Participants
|
|
Thyroid Disease
Presence
|
41 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Thyroid Disease
Hypothyroidism
|
34 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Thyroid Disease
Hyperthyroidism
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Thyroid Disease
Structural abnormality
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Weight (kg)
|
98.011 Weight (kg)
STANDARD_DEVIATION 20.0532 • n=5 Participants
|
98.141 Weight (kg)
STANDARD_DEVIATION 20.5269 • n=7 Participants
|
98.076 Weight (kg)
STANDARD_DEVIATION 20.2732 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: 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.
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.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=281 Participants
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®
n=282 Participants
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
|
|---|---|---|
|
Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint
|
54 Percentage of subjects with TI-AIA
|
60 Percentage of subjects with TI-AIA
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: The Full Analysis Set (FAS) was comprised of all subjects whose treatment assignment was randomly assigned with non-missing baseline values.
Change is HbA1c value at week 26 minus the value at baseline.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=284 Participants
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®
n=283 Participants
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
|
|---|---|---|
|
CFB in HbA1c to Week 26
|
-0.39 Percentage of glycosylated hemoglobin
Standard Error 0.079
|
-0.45 Percentage of glycosylated hemoglobin
Standard Error 0.079
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subset of subjects whose baseline AIA was negative (n=511).
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.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=249 Participants
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®
n=262 Participants
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
|
|---|---|---|
|
Immunogenicity - Percentage of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline
|
42 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subset of subjects in each treatment group with confirmed positive AIA at baseline (n=6).
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.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=5 Participants
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®
n=1 Participants
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
|
|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subjects with Confirmed Positive Anti-Insulin Antibodies at Baseline with non-missing post-baseline AIA titer values (n=3).
The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=2 Participants
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®
n=1 Participants
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
|
|---|---|---|
|
Immunogenicity - Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline
|
23.5 Titers
Standard Deviation 19.09
|
-3.0 Titers
Standard Deviation NA
The calculation of standard deviation for a subset of subjects of size 1 is undefined and therefore reporting standard deviation is not applicable.
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit 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.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=10 Participants
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®
n=16 Participants
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
|
|---|---|---|
|
Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=281 Participants
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®
n=282 Participants
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
|
|---|---|---|
|
Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline
|
58 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: FBG control (FBG ≤ 8.0 mmol/L)
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.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=284 Participants
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®
n=283 Participants
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
|
|---|---|---|
|
Efficacy - Postbaseline FBG Control
Lack of Postbaseline FBG control
|
151 Participants
|
145 Participants
|
|
Efficacy - Postbaseline FBG Control
Sufficient Postbaseline FBG control
|
133 Participants
|
138 Participants
|
SECONDARY outcome
Timeframe: At Week 26Population: HbA1c control (HbA1c \< 7.0%)
The number and percentage of subjects who achieve a HbA1c of \< 7.0% at visit Week 26.
Outcome measures
| Measure |
Gan & Lee Insulin Glargine Injection
n=284 Participants
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®
n=283 Participants
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
|
|---|---|---|
|
Efficacy - HbA1c Control
Lack of Postbaseline HbA1c Control
|
249 Participants
|
246 Participants
|
|
Efficacy - HbA1c Control
Sufficient Postbaseline HbA1c Control
|
35 Participants
|
37 Participants
|
Adverse Events
Gan & Lee Insulin Glargine Injection
Serious events: 15 serious events
Other events: 125 other events
Deaths: 0 deaths
Lantus®
Serious events: 16 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gan & Lee Insulin Glargine Injection
n=281 participants at risk
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®
n=282 participants at risk
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
|
|---|---|---|
|
General disorders
Chest Pain
|
0.71%
2/281 • 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%
0/282 • 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
Osteomyelitis
|
0.71%
2/281 • 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.
|
0.35%
1/282 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.71%
2/281 • 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%
0/282 • 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
Syncope
|
0.71%
2/281 • 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%
0/282 • 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
Hypoglycemia
|
0.00%
0/281 • 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%
0/282 • 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
Non-cardiac chest pain
|
0.36%
1/281 • 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.
|
0.35%
1/282 • 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
Angina pectoris
|
0.00%
0/281 • 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%
1/282 • 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
Angina unstable
|
0.36%
1/281 • 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%
0/282 • 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
Arthritis
|
0.36%
1/281 • 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%
0/282 • 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
B-cell small lymphocytic lymphoma
|
0.00%
0/281 • 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%
1/282 • 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
Back pain
|
0.36%
1/281 • 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%
0/282 • 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
Cardiac failure congestive
|
0.36%
1/281 • 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%
0/282 • 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
Cardiomyopathy
|
0.00%
0/281 • 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%
1/282 • 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
Carotid artery aneurysm
|
0.00%
0/281 • 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%
1/282 • 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.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.36%
1/281 • 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%
0/282 • 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
Chronic lymphocytic leukaemia
|
0.00%
0/281 • 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%
1/282 • 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
Fall
|
0.36%
1/281 • 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%
0/282 • 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
Gastrointestinal haemorrhage
|
0.00%
0/281 • 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%
1/282 • 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
Hypertensive emergency
|
0.00%
0/281 • 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%
1/282 • 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
Infection
|
0.00%
0/281 • 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%
1/282 • 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
Intervertebral disc protrusion
|
0.00%
0/281 • 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%
1/282 • 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
Lactic acidosis
|
0.00%
0/281 • 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%
1/282 • 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
Localised infection
|
0.00%
0/281 • 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%
1/282 • 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
Osteoarthritis
|
0.36%
1/281 • 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%
0/282 • 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.
|
|
Endocrine disorders
Pancreatic carcinoma
|
0.36%
1/281 • 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%
0/282 • 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.
|
|
Endocrine disorders
Pancreatitis acute
|
0.36%
1/281 • 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%
0/282 • 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
Rectal haemorrhage
|
0.00%
0/281 • 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%
1/282 • 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
Renal cell carcinoma
|
0.00%
0/281 • 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%
1/282 • 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
Silent myocardial infarction
|
0.00%
0/281 • 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%
1/282 • 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
Spondylolisthesis
|
0.36%
1/281 • 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%
0/282 • 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
Transient ischaemic attack
|
0.00%
0/281 • 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%
1/282 • 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
Vertebral foraminal stenosis
|
0.36%
1/281 • 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%
0/282 • 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
Wound infection
|
0.00%
0/281 • 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%
1/282 • 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.
|
Other adverse events
| Measure |
Gan & Lee Insulin Glargine Injection
n=281 participants at risk
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®
n=282 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
42.7%
120/281 • Number of events 831 • 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.
|
41.5%
117/282 • Number of events 761 • 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
Headache
|
0.71%
2/281 • 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.
|
0.35%
1/282 • 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.
|
|
Investigations
Weight Increased
|
0.00%
0/281 • 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.
|
1.1%
3/282 • 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.
|
|
Nervous system disorders
Dizziness
|
0.36%
1/281 • 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%
0/282 • 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
|
0.00%
0/281 • 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%
1/282 • 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
Gastroenteritis
|
0.00%
0/281 • 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%
1/282 • 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
Hunger
|
0.00%
0/281 • 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%
1/282 • 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
Injection related
|
0.36%
1/281 • 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%
0/282 • 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
Other
|
0.36%
1/281 • 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%
0/282 • 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