Trial · NCT02227862

Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)

NCT02227862, Phase 3, Completed, Mylan Inc.; results first posted 2020-03-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1). Trials, record NCT02227862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02227862

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
NCT number: NCT02227862
Status: Completed
Phases: Phase 3
Enrollment: 558 participants, actual
Lead sponsor: Mylan Inc.
Conditions: Type 1 Diabetes
Interventions: Mylan's insulin glargine, Lantus®
First posted: 2014-08-28
Last updated: 2022-03-03
Results first posted: 2020-03-09

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Change in HbA1c From Baseline to 24 Weeks	24 weeks
Secondary	Summary of Actual and Change From Baseline in HbA1c	24 and 52 weeks
Secondary	Change From Baseline in FPG Over Time	24 and 52 weeks
Secondary	Change From Baseline in 8-point SMBG Profile Over Time	24 and 52 weeks
Secondary	Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time	24 and 52 weeks
Secondary	Rate of Hypoglycemic Events Per 30 Days Over Time	24 and 52 weeks
Secondary	Hypoglycemia Occurrence	52 weeks
Secondary	Occurrence of Local and Systematic Reactions	52 weeks
Secondary	Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time	24 and 52 weeks
Secondary	Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time	24 and 52 weeks

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in HbA1c From Baseline to 24 Weeks	24 weeks	percent	LEAST_SQUARES_MEAN
SECONDARY	Summary of Actual and Change From Baseline in HbA1c	24 and 52 weeks	percent	MEAN
SECONDARY	Change From Baseline in FPG Over Time	24 and 52 weeks	mmol/L	MEAN
SECONDARY	Change From Baseline in 8-point SMBG Profile Over Time	24 and 52 weeks	mmol/L	MEAN
SECONDARY	Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time	24 and 52 weeks	U/Kg	MEAN
SECONDARY	Rate of Hypoglycemic Events Per 30 Days Over Time	24 and 52 weeks	Episodes/30 Days	MEAN
SECONDARY	Hypoglycemia Occurrence	52 weeks	Number of patients	NUMBER
SECONDARY	Occurrence of Local and Systematic Reactions	52 weeks	Number of patients	NUMBER
SECONDARY	Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time	24 and 52 weeks	%SB	MEAN
SECONDARY	Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time	24 and 52 weeks	%SB	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in HbA1c From Baseline to 24 Weeks	Mylan's Insulin Glargine		0.14	Standard Error 0.054	percent
Change in HbA1c From Baseline to 24 Weeks	Lantus®		0.11	Standard Error 0.054	percent
Summary of Actual and Change From Baseline in HbA1c	Mylan's Insulin Glargine	week 24	0.12	Standard Deviation 0.599	percent
Summary of Actual and Change From Baseline in HbA1c	Lantus®	week 24	0.09	Standard Deviation 0.526	percent
Summary of Actual and Change From Baseline in HbA1c	Mylan's Insulin Glargine	week 52	0.2	Standard Deviation 0.633	percent
Summary of Actual and Change From Baseline in HbA1c	Lantus®	week 52	0.25	Standard Deviation 0.595	percent
Change From Baseline in FPG Over Time	Mylan's Insulin Glargine	week 24	-0.81	Standard Deviation 4.485	mmol/L
Change From Baseline in FPG Over Time	Lantus®	week 24	0.09	Standard Deviation 4.507	mmol/L
Change From Baseline in FPG Over Time	Mylan's Insulin Glargine	week 52	0.23	Standard Deviation 4.281	mmol/L
Change From Baseline in FPG Over Time	Lantus®	week 52	0.43	Standard Deviation 4.455	mmol/L

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mylan's Insulin Glargine	280
Overall Study	STARTED	Lantus®	278
Overall Study	Week 24	Mylan's Insulin Glargine	269
Overall Study	Week 24	Lantus®	263
Overall Study	COMPLETED	Mylan's Insulin Glargine	261
Overall Study	COMPLETED	Lantus®	256
Overall Study	NOT COMPLETED	Mylan's Insulin Glargine	19
Overall Study	NOT COMPLETED	Lantus®	22

Source ClinicalTrials.gov

Adverse events182

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	Hypertension	Vascular disorders	Mylan's Insulin Glargine	9	225	9
other	Hypertension	Vascular disorders	Lantus®	6	239	6
other	Seasonal allergy	Immune system disorders	Mylan's Insulin Glargine	2	225	4
other	Seasonal allergy	Immune system disorders	Lantus®	3	239	3
other	Pyrexia	General disorders	Mylan's Insulin Glargine	5	225	6
other	Pyrexia	General disorders	Lantus®	4	239	4
other	Oedema peripheral	General disorders	Mylan's Insulin Glargine	4	225	4
other	Oedema peripheral	General disorders	Lantus®	3	239	3
other	Fatigue	General disorders	Mylan's Insulin Glargine	4	225	4
other	Fatigue	General disorders	Lantus®	2	239	2

1 to 10 of 182Source ClinicalTrials.gov

See all 182 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mylan's Insulin Glargine	2	280
Total, all-cause mortality	Lantus®	1	278
Total, other adverse events	Mylan's Insulin Glargine	225	225
Total, other adverse events	Lantus®	239	239
Total, serious adverse events	Mylan's Insulin Glargine	18	280
Total, serious adverse events	Lantus®	22	278

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34174848	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Mylan's Insulin Glargine vs Lantus®: deaths from any cause	Trial comparisons
Mylan's Insulin Glargine 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02227862

GET https://conductscience.org/api/trials/v1/NCT02227862/results?page=2

API reference For AI assistants