Extension Study to Assess Safety and Efficacy of Mylan's... | NCT02666430

NCT02666430

Status Module

Sponsor/Collaborators Module

Name	Class
Mylan GmbH	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mylan's insulin glargine	Experimental	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
Lantus®	Active Comparator	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®

Name	Type	Description	Arm Group Labels	Other Names
Mylan's insulin glargine	Drug		Mylan's insulin glargine
Lantus®

Outcomes Module

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

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose		Baseline to 36 weeks
Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline		Baseline to 36 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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.
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
Patients scheduled to receive another investigational drug during the extension study period
Any major elective surgery requiring hospitalization planned during the extension study period.
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/Locations Module

Name	Affiliation	Role
Thomas Blevins	Texas Diabetes & Endocrinology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mylan Investigator Site		Fresno	California	93720	United States
Mylan Investigator Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mylan's Insulin Glargine Sequence	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

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	May 6, 2016	Dec 17, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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. Mylan's insulin glargine
BG001	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. Lantus®
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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00044.8± 11.43 BG00143.2± 12.69 BG00244.0± 12.05

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00127 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0002 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Europe

Title	Measurements
	BG00030 BG00127 BG002

Dosing Time

Number

participants

Title

Denominators

Categories

Morning

Title	Measurements
	BG00011 BG00112 BG002

Baseline HIV Status

Number

participants

Title

Denominators

Categories

Negative

Title	Measurements
	BG00064 BG00162 BG002

Hepatitis B surface antigen (HBsAg)

Number

participants

Title

Denominators

Categories

Negative

Title	Measurements
	BG00064 BG00163 BG002

Baseline hepatitis C antibody (HCVAb)

Number

participants

Title

Denominators

Categories

Low positive

Title	Measurements
	BG0000 BG0011 BG002

Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00080.712± 16.5393 BG00182.415± 15.2942 BG002

Height

Mean

Standard Deviation

centimeters

Title

Denominators

Categories

Title	Measurements
	BG000173.299± 9.9451 BG001174.092± 8.5502 BG002

Body mass index

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00026.744± 4.1795 BG00127.134± 4.4084 BG002

Duration of diabetes

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00021.369± 12.8879 BG00120.212± 8.9657 BG002

Baseline fasting plasma glucose

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.82± 3.455 BG0019.51± 4.099 BG002

Baseline hemoglobin A1c (HbA1c)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG0007.64± 0.997 BG0017.87± 0.913 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

Change in Hemoglobin A1c (HbA1c) From Baseline

Posted

Least Squares Mean

Standard Error

percent

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG00061 OG00157

Title

Denominators

Categories

Title	Measurements
	OG000-0.05± 0.032 OG001-0.06± 0.034

Secondary

Change From Baseline in Fasting Plasma Glucose

Posted

Mean

Standard Deviation

mmol/L

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline

Posted

Mean

Standard Deviation

mmol/L

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Change From Baseline Total Daily Insulin Dose

Posted

Mean

Standard Deviation

Units per kilogram

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Local and Systemic Allergic Reactions

Posted

Number

participants

Baseline to 40 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Hypoglycemic Rate

Posted

Mean

Standard Deviation

episodes/30 days

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Hypoglycemic Incidence

Posted

Number

events

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay

Posted

Mean

Standard Deviation

percent binding

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Insulin Antibodies - Lantus Assay

Posted

Mean

Standard Deviation

percent binding

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay

Posted

Mean

Standard Deviation

percent binding

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay

Posted

Mean

Standard Deviation

percent binding

Baseline to 36 weeks

ID	Title	Description
OG000	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. Mylan's insulin glargine
OG001	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. Lantus®

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	Mylan's Insulin Glargine Sequence	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	0	64	2	64	41	64
EG001	Lantus® Sequence	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®	0	63	5	63	42	63

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Retinal detachment	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Muscle strain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0012 events2 affected63 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0012 events2 affected63 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0012 events2 affected63 at risk
Seasonal allergy	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected64 at risk EG0011 events1 affected63 at risk
Diabetic retinopathy	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0014 events4 affected63 at risk
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0010 events0 affected63 at risk
Stress	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0010 events0 affected63 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0010 events0 affected63 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0011 events1 affected63 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0010 events0 affected63 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0012 events2 affected63 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0012 events2 affected63 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected64 at risk EG0012 events2 affected63 at risk
Herpes zoster	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0013 events3 affected63 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected64 at risk EG0012 events2 affected63 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected64 at risk EG0018 events4 affected63 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected64 at risk EG0011 events1 affected63 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected64 at risk EG0017 events5 affected63 at risk
Rhinitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected63 at risk
Tinea pedis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected63 at risk
Conjunctivitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Cystitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Furuncle	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Onychomycosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Otitis externa fungal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Periodontis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Pulpitis dental	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Tracheitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected63 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected63 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Tooth abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Tooth infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Viral infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected64 at risk EG0011 events1 affected63 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Dental caries	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected63 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected63 at risk

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

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

ID	Term
D000069036	Insulin Glargine

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins