Non-inferiority Study to Compare the Efficacy and Safety... | NCT02227875

Status Module

Name	Class
Mylan GmbH	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mylan's insulin Glargine	Experimental	receive Mylan's insulin Glargine	Drug: Mylan's insulin glargine
Lantus®	Active Comparator	receive Lantus®	Drug: Lantus®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mylan's insulin glargine	Drug	Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

Measure	Description	Time Frame
Change in HbA1c From Baseline to 24 Weeks		24 weeks

Measure	Description	Time Frame
Rate of Hypoglycemic Events Per 30 Days	The change from baseline at 12 and 24 weeks is reported	Baseline and up to 24 weeks
Hypoglycemia Occurrence	Overall hypoglycemic incidence during treatment period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:
- Diagnosis established 1 year prior to screening
- Insulin-naïve OR
- On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening
Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).
Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.
Hemoglobin ≥9.0 g/dL at screening
Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.

Exclusion Criteria:

History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions.
History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.
Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.
Regular use of immune-modulator therapy in the 1 year prior to screening.
History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I) as judged by the investigator.
History of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.
History of drug or alcohol dependence or abuse during the 1 year prior to screening.
Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.

Name	Affiliation	Role
Thomas Blevins, MD	Texas Diabetes & Endocrinology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mylan Investigational Site		Chandler	Arizona	85224	United States
Mylan Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34174848	Derived	Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy AS, Ramaswamy S, Pathak D, Bowsher RR, Raiter Y, Aubonnet P, Barve A. Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies. BMC Endocr Disord. 2021 Jun 26;21(1):129. doi: 10.1186/s12902-021-00797-4.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
BG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
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

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055± 7.91 BG00155.1± 7.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000130 BG001118 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

South Korea

Title	Measurements
	BG0003 BG0014 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 HbA1c From Baseline to 24 Weeks

Intent-to-Treat Population

Posted

Least Squares Mean

95% Confidence Interval

percent

24 weeks

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants	OG000274 OG001278

Title

Denominators

Categories

Title	Measurements
	OG000-0.6(-0.779 to -0.414) OG001-0.66(-0.837 to -0.475)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Net)	0.06	Standard Error of the Mean	0.08	2-Sided	95	-0.098	0.218					Non-Inferiority	Mixed-Effect Model for Repeated Measures

Secondary

Rate of Hypoglycemic Events Per 30 Days

The change from baseline at 12 and 24 weeks is reported

Safety Population

Posted

Mean

Standard Deviation

Episodes/30 Days

Baseline and up to 24 weeks

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants

Secondary

Hypoglycemia Occurrence

Overall hypoglycemic incidence during treatment period

Safety Population

Posted

Number

number of events

24 weeks

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants	OG000

Secondary

Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time

Comparison of change from Baseline in Immunogenicity

Safety Population

Posted

Mean

Standard Deviation

percentage of specific binding (SB)

Week 12 and week 24

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants

Secondary

Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time

Comparison of change from Baseline in Immunogenicity

Safety Population

Posted

Mean

Standard Deviation

percentage of SB

week 12 and week 24

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants

Secondary

Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time

Comparison of change from Baseline in Immunogenicity

Safety Population

Posted

Mean

Standard Deviation

percentage of SB

week 12 and week 24

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants

Secondary

Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time

Comparison of change from Baseline in Immunogenicity

Safety Population

Posted

Mean

Standard Deviation

percentage of SB

Week 12 and week 24

ID	Title	Description
OG000	Mylan's Insulin Glargine	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
OG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Units	Counts
Participants

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	receive Mylan's insulin Glargine Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.	0	276	8	276	177	276
EG001	Lantus®	receive Lantus® Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.	0	282	9	282	164	282

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Helicobacter test positive	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0012 events1 affected282 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Chronic obstructive pulmonary	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Eye haemorrhage	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0012 events2 affected282 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Hyperosmolar hyperglycaemic state	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0012 events1 affected282 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Bronchitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0011 events1 affected282 at risk
Meningitis viral	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0011 events1 affected282 at risk
Paraspinal abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected282 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0006 events6 affected276 at risk EG0012 events2 affected282 at risk
Seasonal allergy	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0014 events4 affected282 at risk
Fatigue	General disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG0012 events2 affected282 at risk
Injection site pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events3 affected276 at risk EG0013 events2 affected282 at risk
Oedema peripheral	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 events2 affected276 at risk EG0016 events6 affected282 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0014 events4 affected282 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0014 events4 affected282 at risk
Lipase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG0011 events1 affected282 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 events5 affected276 at risk EG0015 events5 affected282 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG00110 events10 affected282 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0010 events0 affected282 at risk
Headache	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0009 events8 affected276 at risk EG00111 events10 affected282 at risk
Tremor	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0009 events6 affected276 at risk EG0013 events1 affected282 at risk
Dizziness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG0018 events7 affected282 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0006 events6 affected276 at risk EG0014 events4 affected282 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 events5 affected276 at risk EG0015 events5 affected282 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG00110 events5 affected282 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG0011 events1 affected282 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 events3 affected276 at risk EG0010 events0 affected282 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0010 events0 affected282 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0013 events3 affected282 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0010 events0 affected282 at risk
Dysuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0013 events3 affected282 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 events2 affected276 at risk EG0013 events3 affected282 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0013 events3 affected282 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0007 events7 affected276 at risk EG0016 events6 affected282 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0005 events5 affected276 at risk EG0014 events4 affected282 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events4 affected276 at risk EG0017 events5 affected282 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 events2 affected276 at risk EG0015 events5 affected282 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG000330 events75 affected276 at risk EG001282 events66 affected282 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00019 events17 affected276 at risk EG00115 events15 affected282 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00013 events12 affected276 at risk EG0018 events8 affected282 at risk
Nasopharyngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00011 events10 affected276 at risk EG00114 events13 affected282 at risk
Sinusitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0009 events8 affected276 at risk EG0015 events4 affected282 at risk
Influenza	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0007 events6 affected276 at risk EG0013 events3 affected282 at risk
Bronchitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0005 events5 affected276 at risk EG0017 events7 affected282 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0005 events5 affected276 at risk EG0011 events1 affected282 at risk
Pharyngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0011 events1 affected282 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0010 events0 affected282 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0010 events0 affected282 at risk

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

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