Gan & Lee Insulin Glargine Target Type (1) Evaluating Res... | NCT03371082

NCT03371082

Status Module

Sponsor/Collaborators Module

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
Gan & Lee Insulin Glargine Injection	Experimental	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks.	Biological: Gan & Lee Insulin Glargine Injection
Lantus®	Active Comparator	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.	Biological: Lantus®

Name	Type	Description	Arm Group Labels	Other Names
Gan & Lee Insulin Glargine Injection	Biological	Route of administration: subcutaneous injection	Gan & Lee Insulin Glargine Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment-induced Anti-Insulin Antibody (TI-AIA)	TI-AIA is the Composite of Newly Confirmed Positive AIA or Important-Increase in AIA titer	Assessed up to Week 26

Secondary Outcomes

Measure	Description	Time Frame
Glycosylated Hemoglobin HbA1c	The change between baseline (CFB) in HbA1c and at 26 weeks	Assessed up to Week 26
Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive.
Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study-related procedures.
Ability to understand and fully comply with all study procedures and restrictions.
Subjects with a confirmed diagnosis of type 1 diabetes mellitus who have been on an approved basal and bolus insulin regimen for at least 6 months (the type or brand of insulin should not have changed in the 6 months before screening).
HbA1c ≤ 11.0%.
BMI ≥ 19 kg/m2 and ≤ 35 kg/m2.
Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study.
Concomitant medications are allowed, provided that no significant dosing changes are anticipated during the study (see the exclusion criteria below for specific prohibited concomitant medications); for concomitant thyroid medications, subjects must have been on a stable dosage for 90 days before screening.

Exclusion Criteria:

Participation in another clinical study or use of any study drug within 30 days before screening.
Previous use of a biosimilar insulin, either basal or bolus.
Diabetic ketoacidosis within a year before screening.
Brittle type 1 diabetes mellitus within the year before screening (e.g., multiple hospitalizations related to diabetes mellitus and/or severe hypoglycemia for which the subject required 3rd party assistance).
Any severe, delayed sequela of diabetes mellitus, e.g., worsening end-stage renal disease, advanced coronary artery disease, or myocardial infarction within the year before screening, or autonomic peristaltic problems, e.g., gastroparesis.
Anticipated change in insulin used during the study (change in dosage is allowed, but change in type or brand of insulin will result in the subject being withdrawn from the study).
Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal.
BMI < 19 kg/m2 or > 35 kg/m2.
Any clinically significant (in the opinion of the Investigator) hematology or chemistry test results at screening, including any liver function test > 3x the upper limit of normal (subjects with elevated bilirubin due to Gilbert syndrome are eligible to participate).
Documented history of anti-insulin antibodies.
Treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents within 60 days before screening (newly-prescribed or high-dose corticosteroids are prohibited; chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage are allowed if no increase in dose is anticipated during the study; See Appendix 3 [Section 17.3] for a list of allowed and prohibited medications).
Current use of medication intended to cause weight loss or weight gain.
Alcohol or substance use disorder within the 2 years before screening.
Any previous or anticipated treatment with interferons.
Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma.
Severe concomitant physical or psychiatric diseases or conditions
A history of a positive test result for HIV, hepatitis B, or hepatitis C; any subject who has a positive test result during the study may continue at the discretion of the Investigator.
Any history of pancreatitis or pancreatectomy.
Any diagnosis or condition that requires the subject to undergo procedures that could decrease antibodies in plasma or that would require treatment with immunosuppressant agents.
Any condition e.g., splenectomy, autoimmune disease, or rheumatologic disease, that could affect immunologic responses, could indicate an altered immune system, or could require treatment with a prohibited medication.
Any unresolved infection or a history of active infection within 30 days before screening other than mild or viral illness (as judged by the Investigator).
Any other disease or condition that in the opinion of the Investigator could confound the study results or limit the subject's ability to participate in the study or comply with follow-up procedures; or any other factor that would indicate a significant risk of loss to follow up.
Intolerance or history of hypersensitivity to insulin glargine or any excipient of IP.
Inability or unwillingness to wear the CGM sensor as required for the study, or to comply with the concomitant medication requirements in the FreeStyle Libre Pro Indications and Important Safety Information, during the CGM periods.

Contacts/Locations Module

Name	Affiliation	Role
Jia Lu, MD, PhD	Gan & Lee Pharmaceuticals, USA	Study Director
Elena A. Christofides, MD,FACE	Endocrinology Research Associates, Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Valley Research

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection

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	Apr 30, 2019	Mar 2, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

The number of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26.

All Subjects Assigned randomly to treatment (full analysis set).

Arm/Group Information

ID	Title	Description
BG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
BG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection
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
	BG00045.7± 13.96 BG00146.7± 14.46 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000103 BG001112 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00023 BG00116 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Hungary

Title	Measurements
	BG00020 BG00121 BG002

Anti-Insulin Antibodies (AIA)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Negative	BG000236 BG001239 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00027.01± 3.875 BG00127.11± 4.237 BG002

Duration of Diabetes

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00020.2± 13.88 BG00121.7± 13.95 BG002

Glycosylated Hemoglobin (HbA1c)

Mean

Standard Deviation

HbA1c (%)

Title

Denominators

Categories

Title	Measurements
	BG0008.11± 1.229 BG0018.08± 1.267 BG002

Anti-Insulin Neutralizing Antibodies (NAbs)

Count of Participants

Participants

Title

Denominators

Categories

Negative

Title	Measurements
	BG00044 BG00138 BG002

Thyroid Disease

Number

Participants

Title

Denominators

Categories

Absence

Title	Measurements
	BG000243 BG001210 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00080.901± 13.4277 BG00181.548± 16.3993 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-induced Anti-Insulin Antibody (TI-AIA)

TI-AIA is the Composite of Newly Confirmed Positive AIA or Important-Increase in AIA titer

The Safety Analysis Set (SS) was comprised of all subjects whose treatment assignment was randomly assigned who received any of the study treatment, even a partial dose, and had non-missing values.

Posted

Mean

Standard Deviation

Titers

Assessed up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts
Participants	OG000287 OG001289

Title

Denominators

Categories

Title	Measurements
	OG0004.8± 88.88 OG00142.5± 332.90

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	This is a two-arm study.					Risk Difference (RD)	0.6	Standard Error of the Mean	3.63	2-Sided	90	-5.4	6.5			The asymptotic standard error was planned and is reported above.		Equivalence	The limits of the lower and upper equivalence margin were -11.3 and 11.3, respectively.

Secondary

Glycosylated Hemoglobin HbA1c

The change between baseline (CFB) in HbA1c and at 26 weeks

The Full Analysis Set (FAS) was comprised of all subjects whose treatment assignment was randomly assigned with non-missing baseline values.

Posted

Least Squares Mean

Standard Error

Percent of total hemoglobin

Assessed up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts
Participants

Secondary

Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline

The number of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26.

Subset of subjects whose baseline AIA was negative (n=475).

Posted

Count of Participants

Participants

Assessed up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts

Secondary

Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline.

The number of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to 26 weeks.

Subset of subjects whose baseline AIA was confirmed positive (n=97).

Posted

Count of Participants

Participants

Up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts

Secondary

Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline

The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.

Subjects with Confirmed Positive Anti-Insulin Antibodies at Baseline with non-missing AIA titer values.

Posted

Mean

Standard Deviation

Titers

Assessed up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts
Participants

Secondary

Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline.

The number of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin neutralizing antibodies after baseline and up to visit Week 26.

Safety Analysis Set - Subjects with Confirmed Positive AIA after Baseline.

Posted

Count of Participants

Participants

Up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts

Secondary

Number of Subjects With Confirmed Positive AIA After Baseline.

The number of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.

Safety Analysis Set.

Posted

Count of Participants

Participants

Up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts
Participants

Secondary

Postbaseline FBG Control

The number of subjects who achieve an FBG test result of ≤ 6.0 mmol/L at visit Week 26.

FBG control (FBG ≤ 6.0 mmol/L).

Posted

Count of Participants

Participants

Up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

Units	Counts
Participants

Secondary

HbA1c Control.

The number of subjects who achieve a HbA1c of < 7.0% at visit Week 26.

HbA1c control (HbA1c < 7.0%).

Posted

Count of Participants

Participants

Up to Week 26

ID	Title	Description
OG000	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection
OG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection

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	Gan & Lee Insulin Glargine Injection	Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks. Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection	0	287	10	287	160	287
EG001	Lantus®	Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks. Lantus®: Route of administration: subcutaneous injection	1	289	14	289	161	289

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00020 events3 affected287 at risk EG0011 events1 affected289 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0012 events2 affected289 at risk
Depression	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0012 events2 affected289 at risk
Appendicitis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Benign neoplasm of spinal cord	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Carotid artery occlusion	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Cerebrovascular accident	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Cough	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Craniocerebral injury	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Diabetic ketoacidosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Endocarditis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Gangrene	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Inguinal Hernia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Localised infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Lower limb fracture	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Lumbar vertebral fracture	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Peripheral ischemia	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Post procedural infection	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Rib fracture	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0012 events1 affected289 at risk
Septic shock	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Thrombosis	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Tibia fracture	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003,476 events158 affected287 at risk EG0012,936 events161 affected289 at risk
Weight increase	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected287 at risk EG0011 events1 affected289 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected287 at risk EG0010 events0 affected289 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0004 events2 affected287 at risk EG0013 events1 affected289 at risk
Blood creatine phosphokinase increased	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Contusion	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected287 at risk EG0011 events1 affected289 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Face oedema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected287 at risk EG0010 events0 affected289 at risk
Foot Fracture	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Herpes zoster	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected287 at risk EG0010 events0 affected289 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected287 at risk EG0010 events0 affected289 at risk

First MCP Posted Date

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D006946	Hyperinsulinism

ID	Term
C027235	gallium nitrate
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