Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes | NCT00308737

Status 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
TI Inhalation Powder	Experimental	Technosphere® Insulin Inhalation Powder	Drug: Technosphere® Insulin Inhalation Powder
Usual care	Other	Usual care	Drug: Usual Care
Non-diabetes	No Intervention	Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

Name	Type	Description	Arm Group Labels	Other Names
Technosphere® Insulin Inhalation Powder	Drug	Inhalation, 15U/30U	TI Inhalation Powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care	Change from Baseline to End of Study in FEV1 by MMRM	Baseline to Month 24
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care	FEV1 decrease of ≥ 15% from Baseline value at last measurement	Baseline to Month 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care	Change from Baseline to last measurement(Month 24) in FEV1	Baseline to Month 24
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Health Ltd Research Division		Phoenix	Arizona	85016	United States
Lovelace Scientific Resources

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Technosphere® Insulin	Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
FG001	Usual Care	Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	Technosphere® Insulin	Technosphere Insulin
BG001	Usual Care	Usual care
BG002	Non-diabetes	Subjects without abnormalities in glucose control
BG003	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
	BG00050.8± 11.55 BG00150.4± 11.62 BG00238.2± 12.59 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000366 BG001371 BG002

Body mass index

Mean

Standard Deviation

kilograms per meter squared

Title

Denominators

Categories

Title	Measurements
	BG00029.87± 5.366 BG00129.76± 5.035 BG002

HbA1c

Glycated hemoglobin

Mean

Standard Deviation

percentage

Title

Denominators

Categories

Title	Measurements
	BG0008.7± 1.39 BG0018.7± 1.38 BG002

Weight

Weight in kilograms

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00087.69± 18.628 BG00187.53± 17.638 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 From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care

Change from Baseline to End of Study in FEV1 by MMRM

Intention to Treat (ITT)

Posted

Mean

Standard Deviation

liters

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care

Units	Counts
Participants	OG000730 OG001824

Title

Denominators

Categories

Title	Measurements
	OG000-0.16± 0.208 OG001-0.12± 0.211

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	Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate	Mixed Models Analysis	Repeated measures			Mean Difference (Final Values)	0.037			2-Sided	95	0.014	0.060				Yes	Non-Inferiority or Equivalence	Comparison of TI + Usual Care to Usual Care only

Secondary

Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care

Change from Baseline to last measurement(Month 24) in FEV1

Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

95% Confidence Interval

liters

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM

Change from Baseline to Month 24 in FVC by MMRM

Intention to Treat (ITT)

Posted

Mean

Standard Deviation

liters

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM

Change from baseline to Month 24 in TLC by MMRM

participants in ITT population with available data

Posted

Mean

Standard Deviation

liters

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM

Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM

participants in ITT population with available data

Posted

Mean

Standard Deviation

mL/min/mmHg

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement

FVC Decrease of ≥15% from Baseline Value at Last Measurement

participants in ITT population with available data

Posted

Number

participants

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement

TLC Decrease of ≥ 15% from Baseline Value at Last Measurement

participants in ITT population with available data

Posted

Number

Participants

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement

Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement

participants in ITT population with available data

Posted

Number

Participants

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement

Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement

participants in ITT population with available data

Posted

Number

Participants

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care

Change from baseline in HbA1c at last measurement

Intention to treat (ITT) with last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

percentage

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care

Units	Counts
Participants	OG000

Secondary

Change in Weight From Baseline at Month 24

Change from baseline in weight at Month 24

Safety population at Month 24

Posted

Mean

Standard Deviation

kilograms

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care
OG002	Non-diabetes	Subjects without abnormalities in glucose control

Units	Counts
Participants	OG000

Primary

FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care

FEV1 decrease of ≥ 15% from Baseline value at last measurement

Intention to Treat (ITT)

Posted

Number

Participants

Baseline to Month 24

ID	Title	Description
OG000	Technosphere® Insulin	Technosphere Insulin
OG001	Usual Care	Usual care

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Technosphere® Insulin	Technosphere Insulin	92	923	559	923
EG001	Usual Care	Usual care (taking insulin)	91	949	472	949
EG002	Non-diabetes	Subjects without abnormalities in glucose control	5	163	47	163

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Coronary artery disease	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0005 affected923 at risk EG0013 affected949 at risk EG0020 affected163 at risk
Myocardial infarction	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0014 affected949 at risk EG0020 affected163 at risk
Angina unstable	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Cardiac arrest	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Coronary artery atherosclerosis	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Cardiac failure	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Atrial flutter	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Bundle branch block left	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Hypothyroidism	Endocrine disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Retinal detachment	Eye disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Retinal disorder	Eye disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Eye haemorrhage	Eye disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Glaucoma	Eye disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0003 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Gastritis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Benign colonic polyp	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Chest pain	General disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Generalised oedema	General disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Non-cardiac chest pain	General disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Pneumonia	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0014 affected949 at risk EG0020 affected163 at risk
Diabetic gangrene	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Appendicitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0021 affected163 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Urinary tract infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Carbuncle	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Diverticulitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Furuncle	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Injection site cellulitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Otitis media acute	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Parotitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Perirectal abscess	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Rectal abscess	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Wound infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pyelonephritis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Cellulitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0021 affected163 at risk
Arthritis bacterial	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Bacterial sepsis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Bronchitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Gangrene	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Osteomyelitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Postoperative infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Sepsis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Staphylococcal scalded skin syndrome	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Tonsillitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0010 affected949 at risk EG0021 affected163 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0013 affected949 at risk EG0020 affected163 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Cerebral haemorrhage traumatic	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Blood potassium increased	Investigations	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0009 affected923 at risk EG00110 affected949 at risk EG0020 affected163 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0005 affected923 at risk EG0014 affected949 at risk EG0020 affected163 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0016 affected949 at risk EG0020 affected163 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Localised osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0013 affected949 at risk EG0020 affected163 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Spondylosis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0010 affected949 at risk EG0021 affected163 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0010 affected949 at risk EG0021 affected163 at risk
Loss of consciousness	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0005 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0014 affected949 at risk EG0021 affected163 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Convulsion	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Epilepsy	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0012 affected949 at risk EG0020 affected163 at risk
Radiculitis lumbosacral	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Sciatica	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Depression	Psychiatric disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Suicide attempt	Psychiatric disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0013 affected949 at risk EG0020 affected163 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Renal colic	Renal and urinary disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Renal failure	Renal and urinary disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Aortic stenosis	Vascular disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Circulatory collapse	Vascular disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected923 at risk EG0010 affected949 at risk EG0020 affected163 at risk
Atherosclerosis obliterans	Vascular disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk
Extremity necrosis	Vascular disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected923 at risk EG0011 affected949 at risk EG0020 affected163 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG000119 affected923 at risk EG001143 affected949 at risk EG00235 affected163 at risk
Nasopharyngitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG00067 affected923 at risk EG00169 affected949 at risk EG00214 affected163 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG000365 affected923 at risk EG001370 affected949 at risk EG0020 affected163 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG000257 affected923 at risk EG00142 affected949 at risk EG0025 affected163 at risk

ID	Term
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

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