Mylan Insulin Aspart Study | NCT03760068

Status Module

Name	Class
Mylan GmbH	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
MYL-1601D Product (100 U/mL)	Active Comparator		Drug: MYL-1601D Product
FlexPen NovoLog® (100 U/mL)	Active Comparator		Drug: FlexPen NovoLog®

Name	Type	Description	Arm Group Labels	Other Names
MYL-1601D Product	Drug	(100 U/mL)	MYL-1601D Product (100 U/mL)
FlexPen NovoLog®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment Emergent Antibody Response (TEAR)	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.	Baseline to week 24

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c From Baseline	Mean (SD) change from baseline HbA1c at Week 24.	Baseline to week 24
Change in Fasting Plasma Glucose From Baseline	Mean (SD) change from baseline plasma glucose at Week 24.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Endocrinology Associates Montgomery		Montgomery	Alabama	36106	United States
Phoenician Centers for Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36114990	Derived	Blevins TC, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, Rao A, Vashishta L, Ranganna G, Barve A. Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog(R)) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study. BioDrugs. 2022 Nov;36(6):761-772. doi: 10.1007/s40259-022-00554-6. Epub 2022 Sep 17.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MYL-1601D Product (100 U/mL)	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 14, 2019	Nov 10, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	MYL-1601D Product (100 U/mL)	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.
BG001	FlexPen NovoLog® (100 U/mL)	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000109 BG001108 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Screening Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.56± 4.221 BG00127.00± 4.191 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Treatment Emergent Antibody Response (TEAR)

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.

Type 1 Diabetes Patients

Posted

Count of Participants

Participants

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000238 OG001240

Title

Denominators

Categories

Title	Measurements
	OG00059 OG00167

Secondary

Change in HbA1c From Baseline

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

Type 1 Diabetes Patients

Posted

Mean

Standard Deviation

percentage of change

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Plasma Glucose From Baseline

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

Type 1 Diabetes Patients

Posted

Mean

Standard Deviation

mmol/L

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000

Secondary

Change in Prandial Insulin Dose From Baseline

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

Type 1 Diabetes Patients

Posted

Mean

Standard Deviation

U/kg)

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000

Secondary

Change in Basal Insulin Dose From Baseline

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

Type 1 Diabetes Patients

Posted

Mean

Standard Deviation

U/kg

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000

Secondary

Change in Total Daily Insulin Dose From Baseline

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

Type 1 Diabetes Patients

Posted

Mean

Standard Deviation

U/kg

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000

Secondary

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline

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

Type 1 Diabetes Patients

Posted

Mean

Standard Deviation

mmol/L)

Baseline to week 24

ID	Title	Description
OG000	MYL-1601D Product (100 U/mL)	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.
OG001	FlexPen NovoLog® (100 U/mL)	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MYL-1601D Product (100 U/mL)	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.	0	238	22	238	92	238
EG001	FlexPen NovoLog® (100 U/mL)	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.	1	240	15	240	99	240

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Colititis	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Chest Pain	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Anal Abscess	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Cellulitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Incision Site Cellulitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Perineal Abscess	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Sepsis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected240 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00018 events15 affected238 at risk EG00112 events10 affected240 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Hypoglycemic Seizure	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk
Victim of Homicide	Social circumstances	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected240 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0013 events3 affected240 at risk
Diarrhea	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0006 events6 affected238 at risk EG0013 events2 affected240 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 events4 affected238 at risk EG0012 events2 affected240 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0012 events2 affected240 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0010 events0 affected240 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0010 events0 affected240 at risk
Fatigue	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0010 events0 affected240 at risk
Influenza Like Illness	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0013 events3 affected240 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00015 events14 affected238 at risk EG00119 events15 affected240 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00016 events11 affected238 at risk EG00116 events14 affected240 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00010 events9 affected238 at risk EG00111 events9 affected240 at risk
Sinusitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG00110 events8 affected240 at risk
Influenza	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0014 events4 affected240 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0013 events3 affected240 at risk
Weight Increased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0014 events4 affected240 at risk
Blood Pressure Increased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0005 events3 affected238 at risk EG0013 events3 affected240 at risk
Glycosylated Hemoglobin Increased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0011 events1 affected240 at risk
Crystal Urine Present	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0000 events0 affected238 at risk EG0014 events3 affected240 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0005 events4 affected238 at risk EG0016 events5 affected240 at risk
Hyperlipidemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0013 events3 affected240 at risk
Headache	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00013 events9 affected238 at risk EG0012 events2 affected240 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0016 events6 affected240 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 events1 affected238 at risk EG0013 events3 affected240 at risk
Orophayngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 events3 affected238 at risk EG0010 events0 affected240 at risk
Hypertension	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0006 events6 affected238 at risk EG0014 events4 affected240 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases