Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

• Sponsor: Mylan Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02666430
• Collaborator: Mylan GmbH (Industry)
• Enrollment: 127
• Locations: 81
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Drug: Mylan's insulin glargine; Drug: Lantus®	Phase 3

Detailed Description

This multi-center, open-label, randomized clinical extension study in patients with T1DM will assess safety and efficacy of Mylan's insulin glargine and Lantus®.

Patients with an established diagnosis of T1DM per American Diabetes Association 2014 criteria who were randomized to the Lantus® treatment arm of the Mylan Glargine 3001 study, and who have completed the 52-week treatment period on Lantus® will be eligible to be screened for the MYL-1501D-3003 study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Multi-center, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients: An Extension Study
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mylan's insulin glargine Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.	Drug: Mylan's insulin glargine
Active Comparator: Lantus® Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.	Drug: Lantus®

Outcome Measures

Primary Outcome Measures

1. Change in Hemoglobin A1c (HbA1c) From Baseline [Baseline to 36 weeks]

Secondary Outcome Measures

1. Change From Baseline in Fasting Plasma Glucose [Baseline to 36 weeks]

2. Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline [Baseline to 36 weeks]

3. Change From Baseline Total Daily Insulin Dose [Baseline to 36 weeks]

4. Local and Systemic Allergic Reactions [Baseline to 40 weeks]

5. Hypoglycemic Rate [Baseline to 36 weeks]

6. Hypoglycemic Incidence [Baseline to 36 weeks]

7. Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay [Baseline to 36 weeks]

8. Change From Baseline in Total Insulin Antibodies - Lantus Assay [Baseline to 36 weeks]

9. Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay [Baseline to 36 weeks]

10. Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay [Baseline to 36 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 66 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study.

2. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.

3. The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point self-monitoring blood glucose, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the extension study.

4. Female patients complying with the following:

• Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of randomization throughout the entire study.

• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

• Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study.

• Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-GAI-3001 study.

• All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES.

• If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to inclusion in MYL-GAI-3001 study.

Exclusion Criteria:

1. History or presence of a medical condition or disease that in the Investigator's opinion would place the patient at an unacceptable risk from trial participation.

2. History of clinically significant (i.e., significant enough to alter the insulin dose requirement, as per the Investigator) acute bacterial, viral or fungal systemic infections in the 4 weeks prior to inclusion / randomization (recorded while collecting patient history) in to the MYL-1501D-3003 extension study

3. Patients scheduled to receive another investigational drug during the extension study period

4. Any major elective surgery requiring hospitalization planned during the extension study period.

5. Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of ≥1.5 U/kg/day (Lantus® in U/kg/day or Mylan's insulin glargine in IU/kg/day).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mylan Investigator Site	Fresno	California	United States	93720
2	Mylan Investigator Site	Greenbrae	California	United States	94904
3	Mylan Investigator Site	La Jolla	California	United States	92037
4	Mylan Investigator Site	Northridge	California	United States	91324
5	Mylan Investigator Site	Tustin	California	United States	92780
6	Mylan Investigator Site	Fort Lauderdale	Florida	United States	33312
7	Mylan Investigator Site	New Port Richey	Florida	United States	34652
8	Mylan Investigator Site	Palm Harbor	Florida	United States	34684
9	Mylan Investigator Site	West Palm Beach	Florida	United States	33401
10	Mylan Investigator Site	Atlanta	Georgia	United States	30318
11	Mylan Investigator Site	Columbus	Georgia	United States	31904
12	Mylan Investigator Site	Idaho Falls	Idaho	United States	83404
13	Mylan Investigator Site	Crystal Lake	Illinois	United States	60012
14	Mylan Investigator Site	Springfield	Illinois	United States	62711
15	Mylan Investigator Site	Des Moines	Iowa	United States	50314
16	Mylan Investigator Site	Overland Park	Kansas	United States	66210
17	Mylan Investigator Site	Lexington	Kentucky	United States	40503
18	Mylan Investigator Site	Billings	Montana	United States	59101
19	Mylan Investigator Site	Omaha	Nebraska	United States	68131
20	Mylan Investigator Site	Albany	New York	United States	12206
21	Mylan Investigator Site	Staten Island	New York	United States	10301
22	Mylan Investigator Site	Syracuse	New York	United States	13210
23	Mylan Investigator Site	Asheville	North Carolina	United States	28803
24	Mylan Investigator Site	Burlington	North Carolina	United States	27215
25	Mylan Investigator Site	Greenville	North Carolina	United States	27834
26	Mylan Investigator Site	Morehead City	North Carolina	United States	28557
27	Mylan Investigator Site	Wilmington	North Carolina	United States	28401
28	Mylan Investigator Site	Cincinnati	Ohio	United States	45236
29	Mylan Investigator Site	Mentor	Ohio	United States	44060
30	Mylan Investigator Site	Chattanooga	Tennessee	United States	37411
31	Mylan Investigator Site	Austin	Texas	United States	78731
32	Mylan Investigator Site	Dallas	Texas	United States	75231
33	Mylan Investigator Site	San Antonio	Texas	United States	78258
34	Mylan Investigator Site	Ogden	Utah	United States	84405
35	Mylan Investigator Site	Salt Lake City	Utah	United States	84121
36	Mylan Investigator Site	Chesapeake	Virginia	United States	23321
37	Mylan Investigator Site	Renton	Washington	United States	98057
38	Mylan Investigator Site	Tacoma	Washington	United States	98405
39	Mylan Investigator Site	Vancouver	Washington	United States	98664
40	Mylan Investigator Site	Red Deer	Alberta	Canada
41	Mylan Investigator Site.	Vancouver	British Columbia	Canada
42	Mylan Investigator Site	Winnipeg	Manitoba	Canada
43	Mylan Investigator Site	Laval	Quebec	Canada
44	Mylan Investigator Site	Montreal	Quebec	Canada
45	Mylan Investigator Site	Brno Bohunice		Czechia	625 00
46	Mylan Investigator Site	Ceske Budejovice		Czechia	370 01
47	Mylan Investigator Site	Olomouc		Czechia	77900
48	Mylan Investigator Site	Pardubice		Czechia	530 02
49	Mylan Investigator Site	Praha 10		Czechia	100 34
50	Mylan Investigator Site	Praha		Czechia	120 00
51	Mylan Investigator Site	Parnu		Estonia	80018
52	Mylan Investigator Site	Tallinn		Estonia	13419
53	Mylan Investigator Site	Tartu		Estonia	51014
54	Mylan Investigator Site	Aschaffenburg	Bayern	Germany	63739
55	Mylan Investigator Site	Munster	Nordrhein Westfalen	Germany	48145
56	Mylan Investigator Site	Hohenmolsen	Sachsen Anhalt	Germany	06679
57	Mylan Investigator Site	Hamburg		Germany	20173
58	Mylan Investigator Site	Hamburg		Germany	22607
59	Mylan Investigator Site	Budapest		Hungary	1033
60	Mylan Investigator Site	Budapest		Hungary	1088
61	Mylan Investigator Site	Eger		Hungary	3300
62	Mylan Investigator Site	Letavertes		Hungary	4281
63	Mylan Investigator Site	Miskolc		Hungary	3530
64	Mylan Investigator Site	Szeged		Hungary	H-6722
65	Mylan Investigator Site	Limbazi		Latvia	LV-4001
66	Mylan Investigator Site	Ogre		Latvia	LV-5001
67	Mylan Investigator Site	Riga		Latvia	LV-1011
68	Mylan Investigator Site	Riga		Latvia	LV-1050
69	Mylan Investigator Site	Sigulda		Latvia	LV-2150
70	Mylan Investigator Site	Talsi		Latvia	LV-3200
71	Mylan Investigator Site	Bratislava		Slovakia	82107
72	Mylan Investigator Site	Bratislava		Slovakia	85101
73	Mylan Investigator Site	Dolny Kubin		Slovakia	02601
74	Mylan Investigator Site	Levice		Slovakia	93401
75	Mylan Investigator Site	Lubochna		Slovakia	03491
76	Mylan Investigator Site	Nove Zamky		Slovakia	940 02
77	Mylan Investigator Site	Prievidza		Slovakia	97101
78	Mylan Investigator Site	Rimavska Sobota		Slovakia	97901
79	Mylan Investigator Site	Sturovo		Slovakia	94301
80	Mylan Investigator Site	Trebisov		Slovakia	07501
81	Mylan Investigator Site	Zilina		Slovakia	01001

Sponsors and Collaborators

• Mylan Inc.
• Mylan GmbH

Investigators

• Principal Investigator: Thomas Blevins, Texas Diabetes & Endocrinology

Study Documents (Full-Text)

• Study Protocol - May 6, 2016
• Statistical Analysis Plan - Jul 27, 2016

More Information

Publications

None provided.

• Responsible Party: Mylan Inc.
• ClinicalTrials.gov Identifier: NCT02666430
• Other Study ID Numbers: MYL-1501D-3003
• First Posted: Jan 28, 2016
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Glargine

Study Results

Participant Flow

Arm/Group Title	Mylan's Insulin Glargine Sequence	Lantus® Sequence
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Period Title: Baseline
STARTED	64	63
COMPLETED	64	63
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	64	63
COMPLETED	63	62
NOT COMPLETED	1	1
Period Title: Baseline
STARTED	63	62
COMPLETED	62	58
NOT COMPLETED	1	4
Period Title: Baseline
STARTED	62	58
COMPLETED	61	58
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Mylan's Insulin Glargine	Lantus®	Total
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®	Total of all reporting groups
Overall Participants	64	63	127
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.8 (11.43)	43.2 (12.69)	44.0 (12.05)
Sex: Female, Male (Count of Participants)
Female	23 35.9%	27 42.9%	50 39.4%
Male	41 64.1%	36 57.1%	77 60.6%
Race/Ethnicity, Customized (participants) [Number]
Asian	2 3.1%	0 0%	2 1.6%
Black	2 3.1%	2 3.2%	4 3.1%
Hispanic	1 1.6%	0 0%	1 0.8%
White	59 92.2%	61 96.8%	120 94.5%
Region of Enrollment (participants) [Number]
Europe	30 46.9%	27 42.9%	57 44.9%
North America	34 53.1%	36 57.1%	70 55.1%
Dosing Time (participants) [Number]
Morning	11 17.2%	12 19%	23 18.1%
Evening	53 82.8%	51 81%	104 81.9%
Baseline HIV Status (participants) [Number]
Negative	64 100%	62 98.4%	126 99.2%
Positive	0 0%	1 1.6%	1 0.8%
Hepatitis B surface antigen (HBsAg) (participants) [Number]
Negative	64 100%	63 100%	127 100%
Positive	0 0%	0 0%	0 0%
Baseline hepatitis C antibody (HCVAb) (participants) [Number]
Low positive	0 0%	1 1.6%	1 0.8%
Negative	64 100%	62 98.4%	126 99.2%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	80.712 (16.5393)	82.415 (15.2942)	81.557 (15.8936)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	173.299 (9.9451)	174.092 (8.5502)	173.692 (9.2511)
Body mass index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	26.744 (4.1795)	27.134 (4.4084)	26.937 (4.2820)
Duration of diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.369 (12.8879)	20.212 (8.9657)	20.801 (11.1013)
Baseline fasting plasma glucose (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	9.82 (3.455)	9.51 (4.099)	9.67 (3.779)
Baseline hemoglobin A1c (HbA1c) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	7.64 (0.997)	7.87 (0.913)	7.75 (0.959)

Outcome Measures

1. Primary Outcome

Title	Change in Hemoglobin A1c (HbA1c) From Baseline
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	61	57
Least Squares Mean (Standard Error) [percent]	-0.05 (0.032)	-0.06 (0.034)

2. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [mmol/L]	-0.56 (3.458)	0.10 (4.521)

3. Secondary Outcome

Title	Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [mmol/L]	-0.144 (1.2569)	-0.426 (1.1243)

4. Secondary Outcome

Title	Change From Baseline Total Daily Insulin Dose
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [Units per kilogram]	0.0016 (0.09239)	0.0023 (0.07712)

5. Secondary Outcome

Title	Local and Systemic Allergic Reactions
Time Frame	Baseline to 40 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Local	1 1.6%	1 1.6%
Systemic	1 1.6%	0 0%

6. Secondary Outcome

Title	Hypoglycemic Rate
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [episodes/30 days]	0.627 (2.7180)	0.410 (4.0911)

7. Secondary Outcome

Title	Hypoglycemic Incidence
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Number [events]	58	57

8. Secondary Outcome

Title	Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [percent binding]	-2.098 (5.3826)	-2.474 (5.2505)

9. Secondary Outcome

Title	Change From Baseline in Total Insulin Antibodies - Lantus Assay
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [percent binding]	-1.288 (4.9617)	-2.351 (5.374)

10. Secondary Outcome

Title	Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [percent binding]	-2.051 (5.3697)	-2.252 (5.1904)

11. Secondary Outcome

Title	Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay
Time Frame	Baseline to 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mylan's Insulin Glargine	Lantus®
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
Measure Participants	64	63
Mean (Standard Deviation) [percent binding]	-1.232 (4.8965)	-2.192 (5.1741)

Adverse Events

Time Frame	40 weeks
Arm/Group Title	Mylan's Insulin Glargine Sequence		Lantus® Sequence
Arm/Group Description	Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Mylan's insulin glargine		Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each. Lantus®
All Cause Mortality
	Mylan's Insulin Glargine Sequence		Lantus® Sequence
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/63 (0%)
Serious Adverse Events
	Mylan's Insulin Glargine Sequence		Lantus® Sequence
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/64 (3.1%)		5/63 (7.9%)
Cardiac disorders
Myocardial infarction	1/64 (1.6%)	1	0/63 (0%)	0
Eye disorders
Retinal detachment	0/64 (0%)	0	1/63 (1.6%)	1
Hepatobiliary disorders
Cholecystitis acute	1/64 (1.6%)	1	0/63 (0%)	0
Injury, poisoning and procedural complications
Injury	0/64 (0%)	0	1/63 (1.6%)	1
Metabolism and nutrition disorders
Ketoacidosis	0/64 (0%)	0	1/63 (1.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/64 (0%)	0	1/63 (1.6%)	1
Bladder cancer	0/64 (0%)	0	1/63 (1.6%)	1
Nervous system disorders
Cerebrovascular accident	1/64 (1.6%)	1	0/63 (0%)	0
Other (Not Including Serious) Adverse Events
	Mylan's Insulin Glargine Sequence		Lantus® Sequence
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/64 (64.1%)		42/63 (66.7%)
Eye disorders
Diabetic retinopathy	1/64 (1.6%)	1	4/63 (6.3%)	4
Gastrointestinal disorders
Abdominal pain upper	2/64 (3.1%)	2	0/63 (0%)	0
Diarrhoea	2/64 (3.1%)	2	1/63 (1.6%)	1
Abdominal discomfort	1/64 (1.6%)	1	0/63 (0%)	0
Abdominal distension	1/64 (1.6%)	2	1/63 (1.6%)	1
Abdominal pain	0/64 (0%)	0	1/63 (1.6%)	1
Constipation	1/64 (1.6%)	1	0/63 (0%)	0
Dental caries	1/64 (1.6%)	1	0/63 (0%)	0
Gastritis	1/64 (1.6%)	1	0/63 (0%)	0
Nausea	0/64 (0%)	0	1/63 (1.6%)	1
Oesophagitis ulcerative	0/64 (0%)	0	1/63 (1.6%)	1
Vomiting	1/64 (1.6%)	1	0/63 (0%)	0
General disorders
Fatigue	2/64 (3.1%)	2	0/63 (0%)	0
Immune system disorders
Seasonal allergy	3/64 (4.7%)	4	1/63 (1.6%)	1
Infections and infestations
Bronchitis	1/64 (1.6%)	1	2/63 (3.2%)	2
Gastroenteritis viral	2/64 (3.1%)	2	2/63 (3.2%)	2
Herpes zoster	0/64 (0%)	0	3/63 (4.8%)	3
Influenza	3/64 (4.7%)	3	2/63 (3.2%)	2
Nasopharyngitis	3/64 (4.7%)	3	4/63 (6.3%)	8
Sinusitis	2/64 (3.1%)	3	1/63 (1.6%)	1
Upper respiratory tract infection	7/64 (10.9%)	8	5/63 (7.9%)	7
Rhinitis	1/64 (1.6%)	1	1/63 (1.6%)	1
Tinea pedis	1/64 (1.6%)	1	1/63 (1.6%)	1
Conjunctivitis	0/64 (0%)	0	1/63 (1.6%)	1
Cystitis	0/64 (0%)	0	1/63 (1.6%)	1
Furuncle	0/64 (0%)	0	1/63 (1.6%)	1
Gastroenteritis	0/64 (0%)	0	1/63 (1.6%)	1
Onychomycosis	0/64 (0%)	0	1/63 (1.6%)	1
Otitis externa fungal	0/64 (0%)	0	1/63 (1.6%)	1
Periodontis	0/64 (0%)	0	1/63 (1.6%)	1
Pharyngotonsillitis	1/64 (1.6%)	1	0/63 (0%)	0
Pulpitis dental	1/64 (1.6%)	1	0/63 (0%)	0
Tracheitis	1/64 (1.6%)	1	1/63 (1.6%)	1
Viral upper respiratory tract infection	1/64 (1.6%)	1	1/63 (1.6%)	1
Respiratory tract infection	1/64 (1.6%)	1	0/63 (0%)	0
Respiratory tract infection viral	0/64 (0%)	0	1/63 (1.6%)	1
Tooth abscess	1/64 (1.6%)	1	0/63 (0%)	0
Tooth infection	1/64 (1.6%)	1	0/63 (0%)	0
Viral infection	1/64 (1.6%)	1	0/63 (0%)	0
Injury, poisoning and procedural complications
Muscle strain	2/64 (3.1%)	2	2/63 (3.2%)	2
Chest injury	0/64 (0%)	0	1/63 (1.6%)	1
Contusion	1/64 (1.6%)	1	0/63 (0%)	0
Foot fracture	0/64 (0%)	0	1/63 (1.6%)	1
Hand fracture	1/64 (1.6%)	1	0/63 (0%)	0
Incision site pain	0/64 (0%)	0	1/63 (1.6%)	1
Injury	0/64 (0%)	0	1/63 (1.6%)	1
Ligament rupture	0/64 (0%)	0	1/63 (1.6%)	1
Ligament sprain	1/64 (1.6%)	1	0/63 (0%)	0
Limb injury	1/64 (1.6%)	1	0/63 (0%)	0
Procedural pain	1/64 (1.6%)	1	0/63 (0%)	0
Skin abrasion	1/64 (1.6%)	1	0/63 (0%)	0
Thermal burn	0/64 (0%)	0	1/63 (1.6%)	1
Wound	1/64 (1.6%)	1	0/63 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/64 (0%)	0	2/63 (3.2%)	2
Arthralgia	0/64 (0%)	0	1/63 (1.6%)	1
Arthritis	0/64 (0%)	0	1/63 (1.6%)	1
Psychiatric disorders
Stress	2/64 (3.1%)	2	0/63 (0%)	0
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/64 (0%)	0	2/63 (3.2%)	2
Oropharyngeal pain	1/64 (1.6%)	1	2/63 (3.2%)	2
Skin and subcutaneous tissue disorders
Rash	2/64 (3.1%)	2	0/63 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.