Mylan Insulin Aspart Study

• Sponsor: Mylan Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03760068
• Collaborator: Mylan GmbH (Industry)
• Enrollment: 478
• Locations: 158
• Arms: 2
• Actual Duration (Months): 14.3
• Patients Per Site: 3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: MYL-1601D Product; Drug: FlexPen NovoLog®	Phase 3

Detailed Description

This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.

After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.

Study Design

• Study Type: Interventional
• Actual Enrollment: 478 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients
• Actual Study Start Date: Nov 7, 2018
• Actual Primary Completion Date: Dec 28, 2019
• Actual Study Completion Date: Jan 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MYL-1601D Product (100 U/mL)	Drug: MYL-1601D Product; (100 U/mL)
Active Comparator: FlexPen NovoLog® (100 U/mL)	Drug: FlexPen NovoLog®; (100 U/mL)

Outcome Measures

Primary Outcome Measures

1. Treatment Emergent Antibody Response (TEAR) [Baseline to week 24]

   The number of subjects who were TEAR positive. TEAR is defined as either one of the following: Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.

Secondary Outcome Measures

1. Change in HbA1c From Baseline [Baseline to week 24]

   Mean (SD) change from baseline HbA1c at Week 24.

2. Change in Fasting Plasma Glucose From Baseline [Baseline to week 24]

   Mean (SD) change from baseline plasma glucose at Week 24.

3. Change in Prandial Insulin Dose From Baseline [Baseline to week 24]

   Mean (SD) change from baseline daily mealtime insulin dose at Week 24.

4. Change in Basal Insulin Dose From Baseline [Baseline to week 24]

   Mean (SD) change from baseline total daily insulin dose at Week 24.

5. Change in Total Daily Insulin Dose From Baseline [Baseline to week 24]

   Mean (SD) change from baseline total daily insulin dose at Week 24

6. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline [Baseline to week 24]

   Mean (SD) change in 7-point SMBG profile from baseline to Week 24

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Written and signed informed consent.

2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.

3. Subject is able and willing to comply with the requirements of the study protocol.

Exclusion Criteria

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

2. History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.

3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.

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

5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.

6. Subjects with major depressive illness in the last 3 years.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology Associates Montgomery	Montgomery	Alabama	United States	36106
2	Phoenician Centers for Research	Phoenix	Arizona	United States	85012
3	Precision Trials	Phoenix	Arizona	United States	85032
4	Medical Investigations Inc.	Little Rock	Arkansas	United States	72211
5	John Muir Physician Network	Concord	California	United States	94520
6	Valley Research	Fresno	California	United States	93720
7	Marin Endocrine Care & Research, Inc.	Greenbrae	California	United States	94904
8	Diabetes/Lipid Management and Research Center	Huntington Beach	California	United States	92648
9	Diabetes And Endocrine Associates	La Mesa	California	United States	91942
10	Long Beach Center For Clinical Research	Long Beach	California	United States	90807
11	Office of Richard S. Cherlin, M.D	Los Gatos	California	United States	95032
12	The Rose Salter Medical Research Foundation	Newport Beach	California	United States	92657
13	Providence Clinical Research	North Hollywood	California	United States	91606
14	California Medical Research Associates Inc	Northridge	California	United States	91324
15	Pacific Reserach Partners	Oakland	California	United States	94607
16	Palmtree Clinical Research, Inc.	Palm Springs	California	United States	92262
17	Western Univ of Health Science	Pomona	California	United States	91766
18	Mills-Peninsula Health Services Diabetes Research Institute	San Mateo	California	United States	94401
19	NorCal Endocrinology and Internal Medicine	San Ramon	California	United States	94583
20	Sansum Diabetes Research Institute	Santa Barbara	California	United States	93105
21	Coastal Biomedical Research, Inc.	Santa Monica	California	United States	90404
22	The Metabolic Institute Of America (Mioa Inc)	Tarzana	California	United States	91356
23	Diabetes Research Center	Tustin	California	United States	92780
24	Dr.Ronald H. Chochinov MD,Office Of	Ventura	California	United States	93003
25	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
26	Barbara Davis Center for Diabetes	Aurora	Colorado	United States	80045
27	Creekside Endocrine Associates, PC	Denver	Colorado	United States	80246
28	New West Physicians	Golden	Colorado	United States	80401
29	Paradigm Research	Wheat Ridge	Colorado	United States	80033
30	Meridien Research	Bradenton	Florida	United States	34201
31	Hi Tech and Global Research, LLC	Coral Gables	Florida	United States	33134
32	Moonshine Research Center, Inc.	Doral	Florida	United States	33166
33	Northeast Research Institute	Fleming Island	Florida	United States	32003
34	Eastern Research, Inc.	Hialeah	Florida	United States	33013
35	East Coast Institute for Research, LLC	Jacksonville	Florida	United States	32216
36	Care Research Center, Inc	Kendall	Florida	United States	33175
37	Meridien Research	Lakeland	Florida	United States	33805
38	Central Florida Endocrine & Diabetes Consultants	Maitland	Florida	United States	32751
39	Meridien Research	Maitland	Florida	United States	32751
40	Inpatient Research Clinic	Miami Lakes	Florida	United States	33014
41	Pharmax Research Clinic, Inc.	Miami	Florida	United States	33126
42	Quality Professional Healthcare	Miami	Florida	United States	33126
43	Life Spring Research Foundation	Miami	Florida	United States	33130
44	Cordova Research Institute	Miami	Florida	United States	33155
45	DL Research Solutions Inc	Miami	Florida	United States	33155
46	Baptist Diabetes Associates, Pa	Miami	Florida	United States	33156
47	Medi Clear Medical & Research Center, Inc	Miami	Florida	United States	33165
48	Phoenix Medical Research LLC	Miami	Florida	United States	33165
49	Dr. De Armas Research Center, LLC	Miami	Florida	United States	33174
50	P & S Research, LLC	Miami	Florida	United States	33175
51	Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare	Orlando	Florida	United States	32806
52	Omega Research Maitland, LLC	Orlando	Florida	United States	32808
53	Ribo Research, LLC dba Peninsula Research, Inc	Ormond Beach	Florida	United States	32174
54	Suncoast Clinical Research Inc.	Palm Harbor	Florida	United States	34684
55	Hanson Clinical Research Center	Port Charlotte	Florida	United States	33952
56	Progressive Medical Research	Port Orange	Florida	United States	32127
57	Meridien Research	Saint Petersburg	Florida	United States	33709
58	Meridien Research	Spring Hill	Florida	United States	34609
59	Meridien Research	Tampa	Florida	United States	33634
60	Asclepes Research Centers	Weeki Wachee	Florida	United States	34607
61	Metabolic Research Institute, Inc.	West Palm Beach	Florida	United States	33401
62	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
63	IACT Health	Columbus	Georgia	United States	31904
64	Physicians Research Associates, LLC	Lawrenceville	Georgia	United States	30046
65	The Jones Center for Diabetes and Endrocrine Wellness	Macon	Georgia	United States	31210
66	In-Quest Medical Research, LLC	Peachtree Corners	Georgia	United States	30071
67	Endocrine Research Solutions, Inc.	Roswell	Georgia	United States	30076
68	Rocky Mountain Diabetes And Osteoporosis Center	Idaho Falls	Idaho	United States	83404
69	Advanced Clinical Research	Meridian	Idaho	United States	83642
70	Northwest Endo Diabets Res.LLC	Arlington Heights	Illinois	United States	60005
71	Midwest Endocrinology	Crystal Lake	Illinois	United States	60012
72	NorthShore University Health System	Skokie	Illinois	United States	60077
73	American Research, LLC	Jeffersonville	Indiana	United States	47130
74	West Broadway Clinic	Council Bluffs	Iowa	United States	51501
75	Iowa Diabetes and Endocrinology Research Center (IDERC)	West Des Moines	Iowa	United States	50265
76	Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group	Overland Park	Kansas	United States	66210
77	Cotton O'Neil Clinical Research Ctr	Topeka	Kansas	United States	66606
78	Veterans Affairs Medical Center	Lexington	Kentucky	United States	40502
79	Kentucky Diabetes And Endocrinology Center	Lexington	Kentucky	United States	40503
80	Crescent City Clinical Research Center, LLC	Metairie	Louisiana	United States	70006
81	Model Clinical Research	Baltimore	Maryland	United States	21204
82	Boston University School Of Medicine	Boston	Massachusetts	United States	02118
83	MassResearch	Waltham	Massachusetts	United States	02453
84	Elite Clinical Research	Flint	Michigan	United States	48532
85	Professional Clinical Research	Traverse City	Michigan	United States	49686
86	Diabetes & Endocrinology Specialists, Inc.	Chesterfield	Missouri	United States	63017
87	Jefferson City Medical Group (Jcmg) - Jcmg Medical Building	Jefferson City	Missouri	United States	65109
88	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
89	Mercy Research	Springfield	Missouri	United States	65807
90	Billings Clinic Research Center	Billings	Montana	United States	59101
91	Mercury Street Medical Group, PLLC	Butte	Montana	United States	59701
92	Glacier View Research Institute - Endocrinology	Kalispell	Montana	United States	59901
93	Diabetes & Endocrine Associates, PC Research Center	Omaha	Nebraska	United States	68114
94	Alegent Health Research Center	Omaha	Nebraska	United States	68124
95	Palm Research Center, Inc.	Las Vegas	Nevada	United States	89148
96	Northern Nevada Endocrinology	Reno	Nevada	United States	89519
97	Southern New Hampshire Diabetes and Endocrinology	Nashua	New Hampshire	United States	03063
98	Albany Medical College	Albany	New York	United States	12206
99	NY Scientific	Brooklyn	New York	United States	11235
100	Northwell Health	Great Neck	New York	United States	11021
101	Scott Research,Inc	Laurelton	New York	United States	11413
102	Winthrop-University Hospital, Clinical Trials Center	Mineola	New York	United States	11501
103	North Shore Diabetes and Endocrine Associates	New Hyde Park	New York	United States	11042
104	Endocrine Associates of West Village	New York	New York	United States	10001
105	Manhattan Medical Research Practice	New York	New York	United States	10016
106	Dr. Jonas Leibowitz MD, Office Of	Yonkers	New York	United States	10704
107	Mountain Diabetes	Asheville	North Carolina	United States	28803
108	Medication Management, LLC	Greensboro	North Carolina	United States	27408
109	Physician's East, PA	Greenville	North Carolina	United States	27834
110	Carteret Medical Group	Morehead City	North Carolina	United States	28557
111	Lucas Research, Inc.	Morehead City	North Carolina	United States	28857
112	Medication Management, LLC	Raleigh	North Carolina	United States	27609
113	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
114	Lillestol Research LLC	Fargo	North Dakota	United States	58104
115	Diabetes & Endocrinology Associates of Stark County Inc	Canton	Ohio	United States	44718
116	Sterling Research Group, Ltd	Cincinnati	Ohio	United States	45246
117	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
118	Intend Clinical Research	Norman	Oklahoma	United States	73069
119	Lynn Institute of Norman	Norman	Oklahoma	United States	73069
120	Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office	Bend	Oregon	United States	97702
121	Care Access Research, Warwick	Warwick	Rhode Island	United States	02886
122	Mountain View Clinical Research, Inc.	Greer	South Carolina	United States	29651
123	Carolina Health Specialist	Myrtle Beach	South Carolina	United States	29572
124	Meridian Clinical Research	Dakota Dunes	South Dakota	United States	57049
125	Holston Medical Group	Bristol	Tennessee	United States	37620
126	University Diabetes & Endocrine Consultants	Chattanooga	Tennessee	United States	37411
127	WR Clinsearch, LLC	Chattanooga	Tennessee	United States	37421
128	Omega Research Nashville, LLC	Nashville	Tennessee	United States	37211
129	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212
130	Amarillo Medical Specialists	Amarillo	Texas	United States	79106
131	Texas Diabetes & Endocrinology	Austin	Texas	United States	78731
132	North Texas Endocrine Center	Dallas	Texas	United States	75231
133	Research Institute of Dallas	Dallas	Texas	United States	75231
134	Baylor Research Institute	Dallas	Texas	United States	75246
135	UT Southwestern Medical Center Division of Endocrinology	Dallas	Texas	United States	75390
136	UT Southwestern Medical Center	Dallas	Texas	United States	75390
137	Academy of Diabetes Thyroid and Endocrine	El Paso	Texas	United States	79935
138	Diabetes and Thyroid Center of Fort Worth	Fort Worth	Texas	United States	76132
139	Victorium Clinical Research	Houston	Texas	United States	77024
140	Juno Research, LLC	Houston	Texas	United States	77040
141	Endocrine IPS, PLLC	Houston	Texas	United States	77079
142	Clinova Clinical Trials	Houston	Texas	United States	77082
143	Biopharma Informatic, LLC	Houston	Texas	United States	77084
144	Dr.Amir Ali Hassan, MD Off of	Houston	Texas	United States	77089
145	North Hills Medical Research, Inc.	North Richland Hills	Texas	United States	76180
146	Clinical Trials of Texas, Inc	San Antonio	Texas	United States	78229
147	Science Advancing Medicine (Sam) Clinical Research	San Antonio	Texas	United States	78229
148	Victorium Clinical Research	San Antonio	Texas	United States	78230
149	Northeast Clinical Research, LLC	Schertz	Texas	United States	78154
150	Consano Clinical Research	Shavano Park	Texas	United States	78231
151	DM Clinical Research	Tomball	Texas	United States	77375
152	Bay Area Metabolic Health	Webster	Texas	United States	77598
153	Wasatch Clinical Research,LLC	Salt Lake City	Utah	United States	84107
154	Dr.David Gorson Md, Office Of	Bennington	Vermont	United States	05201
155	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
156	Dr. Larry D. Stonesifer,MD,Office Of	Federal Way	Washington	United States	98003
157	Multicare Health System Research Institute	Spokane	Washington	United States	99202
158	The Vancouver Clinic, Inc. PS	Vancouver	Washington	United States	98664

Sponsors and Collaborators

• Mylan Inc.
• Mylan GmbH

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 14, 2019
• Statistical Analysis Plan - Mar 2, 2020

More Information

Publications

None provided.

• Responsible Party: Mylan Inc.
• ClinicalTrials.gov Identifier: NCT03760068
• Other Study ID Numbers: MYL-1601D-3001
• First Posted: Nov 30, 2018
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Aspart

Study Results

Participant Flow

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Period Title: Overall Study
STARTED	238	240
COMPLETED	224	217
NOT COMPLETED	14	23

Baseline Characteristics

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)	Total
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog® (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	Total of all reporting groups
Overall Participants	238	240	478
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	238 100%	240 100%	478 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	109 45.8%	108 45%	217 45.4%
Male	129 54.2%	132 55%	261 54.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%	0 0%	1 0.2%
Asian	6 2.5%	9 3.8%	15 3.1%
Native Hawaiian or Other Pacific Islander	3 1.3%	2 0.8%	5 1%
Black or African American	15 6.3%	11 4.6%	26 5.4%
White	210 88.2%	210 87.5%	420 87.9%
More than one race	3 1.3%	8 3.3%	11 2.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Screening Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.56 (4.221)	27.00 (4.191)	27.28 (4.211)

Outcome Measures

1. Primary Outcome

Title	Treatment Emergent Antibody Response (TEAR)
Description	The number of subjects who were TEAR positive. TEAR is defined as either one of the following: Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Count of Participants [Participants]	59 24.8%	67 27.9%

2. Secondary Outcome

Title	Change in HbA1c From Baseline
Description	Mean (SD) change from baseline HbA1c at Week 24.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Mean (Standard Deviation) [percentage of change]	0.10 (0.735)	0.04 (0.723)

3. Secondary Outcome

Title	Change in Fasting Plasma Glucose From Baseline
Description	Mean (SD) change from baseline plasma glucose at Week 24.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Mean (Standard Deviation) [mmol/L]	0.400 (5.8162)	0.599 (5.1553)

4. Secondary Outcome

Title	Change in Prandial Insulin Dose From Baseline
Description	Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Mean (Standard Deviation) [U/kg)]	0.0079 (0.14608)	-0.0008 (0.09731)

5. Secondary Outcome

Title	Change in Basal Insulin Dose From Baseline
Description	Mean (SD) change from baseline total daily insulin dose at Week 24.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Mean (Standard Deviation) [U/kg]	0.0053 (0.06459)	0.0001 (0.05152)

6. Secondary Outcome

Title	Change in Total Daily Insulin Dose From Baseline
Description	Mean (SD) change from baseline total daily insulin dose at Week 24
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Mean (Standard Deviation) [U/kg]	0.0178 (0.15888)	0.0024 (0.10649)

7. Secondary Outcome

Title	Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline
Description	Mean (SD) change in 7-point SMBG profile from baseline to Week 24
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

Type 1 Diabetes Patients

Arm/Group Title	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
Measure Participants	238	240
Mean (Standard Deviation) [mmol/L)]	0.1180 (2.09287)	0.0999 (1.86471)

Adverse Events

Time Frame	Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
Arm/Group Title	MYL-1601D Product (100 U/mL)		FlexPen NovoLog® (100 U/mL)
Arm/Group Description	MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.		FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
All Cause Mortality
	MYL-1601D Product (100 U/mL)		FlexPen NovoLog® (100 U/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/238 (0%)		1/240 (0.4%)
Serious Adverse Events
	MYL-1601D Product (100 U/mL)		FlexPen NovoLog® (100 U/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/238 (9.2%)		15/240 (6.3%)
Blood and lymphatic system disorders
Anemia	1/238 (0.4%)	1	0/240 (0%)	0
Gastrointestinal disorders
Colititis	1/238 (0.4%)	1	0/240 (0%)	0
General disorders
Chest Pain	1/238 (0.4%)	1	0/240 (0%)	0
Infections and infestations
Anal Abscess	1/238 (0.4%)	1	0/240 (0%)	0
Cellulitis	1/238 (0.4%)	1	0/240 (0%)	0
Gastroenteritis	0/238 (0%)	0	1/240 (0.4%)	1
Incision Site Cellulitis	1/238 (0.4%)	1	0/240 (0%)	0
Perineal Abscess	1/238 (0.4%)	1	0/240 (0%)	0
Pneumonia	0/238 (0%)	0	1/240 (0.4%)	1
Pyelonephritis	0/238 (0%)	0	1/240 (0.4%)	1
Sepsis	0/238 (0%)	0	1/240 (0.4%)	1
Injury, poisoning and procedural complications
Concussion	0/238 (0%)	0	1/240 (0.4%)	1
Skin Laceration	1/238 (0.4%)	1	0/240 (0%)	0
Metabolism and nutrition disorders
Hypoglycemia	15/238 (6.3%)	18	10/240 (4.2%)	12
Diabetic Ketoacidosis	0/238 (0%)	0	1/240 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma	0/238 (0%)	0	1/240 (0.4%)	1
Nervous system disorders
Hypoglycemic Seizure	0/238 (0%)	0	1/240 (0.4%)	1
Psychiatric disorders
Suicidal Ideation	0/238 (0%)	0	1/240 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	0/238 (0%)	0	1/240 (0.4%)	1
Social circumstances
Victim of Homicide	0/238 (0%)	0	1/240 (0.4%)	1
Other (Not Including Serious) Adverse Events
	MYL-1601D Product (100 U/mL)		FlexPen NovoLog® (100 U/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/238 (38.7%)		99/240 (41.3%)
Blood and lymphatic system disorders
Anemia	1/238 (0.4%)	1	3/240 (1.3%)	3
Gastrointestinal disorders
Diarrhea	6/238 (2.5%)	6	2/240 (0.8%)	3
Nausea	4/238 (1.7%)	4	2/240 (0.8%)	2
Food Poisoning	3/238 (1.3%)	3	2/240 (0.8%)	2
Dyspepsia	3/238 (1.3%)	3	0/240 (0%)	0
Gastroesophageal Reflux Disease	3/238 (1.3%)	3	0/240 (0%)	0
General disorders
Fatigue	3/238 (1.3%)	3	0/240 (0%)	0
Influenza Like Illness	0/238 (0%)	0	3/240 (1.3%)	3
Infections and infestations
Nasopharyngitis	14/238 (5.9%)	15	15/240 (6.3%)	19
Upper Respiratory Tract Infection	11/238 (4.6%)	16	14/240 (5.8%)	16
Urinary Tract Infection	9/238 (3.8%)	10	9/240 (3.8%)	11
Sinusitis	1/238 (0.4%)	1	8/240 (3.3%)	10
Influenza	0/238 (0%)	0	4/240 (1.7%)	4
Gastroenteritis	0/238 (0%)	0	3/240 (1.3%)	3
Investigations
Weight Increased	3/238 (1.3%)	3	4/240 (1.7%)	4
Blood Pressure Increased	3/238 (1.3%)	5	3/240 (1.3%)	3
Glycosylated Hemoglobin Increased	3/238 (1.3%)	3	1/240 (0.4%)	1
Crystal Urine Present	0/238 (0%)	0	3/240 (1.3%)	4
Metabolism and nutrition disorders
Hyperglycemia	4/238 (1.7%)	5	5/240 (2.1%)	6
Hyperlipidemia	1/238 (0.4%)	1	3/240 (1.3%)	3
Nervous system disorders
Headache	9/238 (3.8%)	13	2/240 (0.8%)	2
Respiratory, thoracic and mediastinal disorders
Cough	1/238 (0.4%)	1	6/240 (2.5%)	6
Sinus Congestion	1/238 (0.4%)	1	3/240 (1.3%)	3
Orophayngeal Pain	3/238 (1.3%)	3	0/240 (0%)	0
Vascular disorders
Hypertension	6/238 (2.5%)	6	4/240 (1.7%)	4

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.