Trial · NCT03371082
Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
NCT03371082, Phase 3, Completed, Gan and Lee Pharmaceuticals, USA; results first posted 2024-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gan & Lee Insulin Glargine Target Type (1) Evaluating Research. Trials, record NCT03371082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03371082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
- NCT number
- NCT03371082
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 576 participants, actual
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Gan & Lee Insulin Glargine Injection, Lantus®
- First posted
- 2017-12-13
- Last updated
- 2024-05-14
- Results first posted
- 2024-05-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-induced Anti-Insulin Antibody (TI-AIA) | Assessed up to Week 26 | TI-AIA is the Composite of Newly Confirmed Positive AIA or Important-Increase in AIA titer |
| Secondary | Glycosylated Hemoglobin HbA1c | Assessed up to Week 26 | The change between baseline (CFB) in HbA1c and at 26 weeks |
| Secondary | Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline | Assessed up to Week 26 | 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. |
| Secondary | Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline. | Up to Week 26 | 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. |
| Secondary | Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline | Assessed up to Week 26 | The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26. |
| Secondary | Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline. | Up to Week 26 | 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. |
| Secondary | Number of Subjects With Confirmed Positive AIA After Baseline. | Up to Week 26 | The number of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26. |
| Secondary | Postbaseline FBG Control | Up to Week 26 | The number of subjects who achieve an FBG test result of ≤ 6.0 mmol/L at visit Week 26. |
| Secondary | HbA1c Control. | Up to Week 26 | The number of subjects who achieve a HbA1c of \< 7.0% at visit Week 26. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment-induced Anti-Insulin Antibody (TI-AIA) | Assessed up to Week 26 | 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. | Titers | MEAN |
| SECONDARY | Glycosylated Hemoglobin HbA1c | Assessed up to Week 26 | The Full Analysis Set (FAS) was comprised of all subjects whose treatment assignment was randomly assigned with non-missing baseline values. | Percent of total hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline | Assessed up to Week 26 | Subset of subjects whose baseline AIA was negative (n=475). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline. | Up to Week 26 | Subset of subjects whose baseline AIA was confirmed positive (n=97). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline | Assessed up to Week 26 | Subjects with Confirmed Positive Anti-Insulin Antibodies at Baseline with non-missing AIA titer values. | Titers | MEAN |
| SECONDARY | Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline. | Up to Week 26 | Safety Analysis Set - Subjects with Confirmed Positive AIA after Baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Confirmed Positive AIA After Baseline. | Up to Week 26 | Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Postbaseline FBG Control | Up to Week 26 | FBG control (FBG ≤ 6.0 mmol/L). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | HbA1c Control. | Up to Week 26 | HbA1c control (HbA1c \< 7.0%). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-induced Anti-Insulin Antibody (TI-AIA) | Gan & Lee Insulin Glargine Injection | 4.8 | Standard Deviation 88.88 | Titers | |
| Treatment-induced Anti-Insulin Antibody (TI-AIA) | Lantus® | 42.5 | Standard Deviation 332.90 | Titers | |
| Glycosylated Hemoglobin HbA1c | Gan & Lee Insulin Glargine Injection | -0.08 | Standard Error 0.072 | Percent of total hemoglobin | |
| Glycosylated Hemoglobin HbA1c | Lantus® | 0.00 | Standard Error 0.061 | Percent of total hemoglobin | |
| Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline | Gan & Lee Insulin Glargine Injection | 63 | Participants | ||
| Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline | Lantus® | 59 | Participants | ||
| Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline. | Gan & Lee Insulin Glargine Injection | 11 | Participants | ||
| Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline. | Lantus® | 14 | Participants | ||
| Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline | Gan & Lee Insulin Glargine Injection | 4.8 | Standard Deviation 88.88 | Titers | |
| Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline | Lantus® | -42.5 | Standard Deviation 332.90 | Titers |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gan & Lee Insulin Glargine Injection | 287 | |
| Overall Study | STARTED | Lantus® | 289 | |
| Overall Study | COMPLETED | Gan & Lee Insulin Glargine Injection | 258 | |
| Overall Study | COMPLETED | Lantus® | 255 | |
| Overall Study | NOT COMPLETED | Gan & Lee Insulin Glargine Injection | 29 | |
| Overall Study | NOT COMPLETED | Lantus® | 34 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglycemia | Metabolism and nutrition disorders | Gan & Lee Insulin Glargine Injection | 158 | 287 | 3,476 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Lantus® | 161 | 289 | 2,936 |
| other | Weight increase | Investigations | Gan & Lee Insulin Glargine Injection | 3 | 287 | 3 |
| other | Weight increase | Investigations | Lantus® | 1 | 289 | 1 |
| other | Fatigue | General disorders | Gan & Lee Insulin Glargine Injection | 3 | 287 | 3 |
| other | Fatigue | General disorders | Lantus® | 0 | 289 | 0 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Gan & Lee Insulin Glargine Injection | 2 | 287 | 4 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Lantus® | 1 | 289 | 3 |
| other | Blood creatine phosphokinase increased | Metabolism and nutrition disorders | Gan & Lee Insulin Glargine Injection | 1 | 287 | 1 |
| other | Blood creatine phosphokinase increased | Metabolism and nutrition disorders | Lantus® | 0 | 289 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gan & Lee Insulin Glargine Injection | 0 | 287 |
| Total, all-cause mortality | Lantus® | 1 | 289 |
| Total, other adverse events | Gan & Lee Insulin Glargine Injection | 160 | 287 |
| Total, other adverse events | Lantus® | 161 | 289 |
| Total, serious adverse events | Gan & Lee Insulin Glargine Injection | 10 | 287 |
| Total, serious adverse events | Lantus® | 14 | 289 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gan & Lee Insulin Glargine Injection vs Lantus®: Number of Subjects With Confirmed Positive AIA After Baseline. | Trial comparisons |
| Gan & Lee Insulin Glargine Injection vs Lantus®: Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline. | Trial comparisons |
| Gan & Lee Insulin Glargine Injection vs Lantus®: Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline | Trial comparisons |
| Gan & Lee Insulin Glargine Injection vs Lantus®: Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline. | Trial comparisons |
| Gan & Lee Insulin Glargine Injection vs Lantus®: deaths from any cause | Trial comparisons |
| Gan & Lee Insulin Glargine Injection vs Lantus®: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03371082
GET https://conductscience.org/api/trials/v1/NCT03371082/results?page=2