This Study Is To Determine If Inhaled Insulin Is Effectiv... | NCT00418522

Label	Type	Description	Intervention Names
Insulin glargine	Active Comparator	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.	Drug: Insulin glargine
Exubera	Experimental	Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.	Drug: Inhaled Insulin (Exubera)

Name	Type	Description	Arm Group Labels	Other Names
Insulin glargine	Drug	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population	HbA1c lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26

Measure	Description	Time Frame
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26	Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.	Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS	HbA1c lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Phoenix	Arizona	85051	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
FG001	Insulin Glargine

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 in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

HbA1c lab value: Change = value at Week 26 minus value at Baseline.

Per protocol (PP)=Full Analysis Set (FAS) subjects (i.e., had >=1 study drug dose and >=1 post-baseline measurement) with >=12 weeks treatment and no major protocol violation. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c values at Baseline and Week 26: inhaled human insulin n=154, insulin glargine n=157.

Posted

Mean

Standard Deviation

percent

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000154 OG001157

Title

Denominators

Categories

Title	Measurements
	OG000-2.01± 1.39 OG001-1.75± 1.40

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	The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.	ANCOVA		<0.0001		Mean Difference (Final Values)	-0.19				95	-0.38	0			A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.		Non-Inferiority or Equivalence

Secondary

Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26

Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 6.5% at Week 26: inhaled human insulin n=72, insulin glargine n=42.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26

Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 7.0% at Week 26: inhaled human insulin n=127, insulin glargine n=90.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26

Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 8.0% at Week 26: inhaled human insulin n=162, insulin glargine n=158.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Plasma Glucose at Week 26

Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting plasma glucose at Baseline and Week 26: inhaled human insulin n=202, insulin glargine n=189.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26

Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting and postprandial blood glucose measurements determined by standardized meal tolerance tests at Baseline and Week 26: n=inhaled human insulin, insulin glargine.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts

Secondary

Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26

Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.

FAS = all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with postprandial blood glucose measurements as measured by 8-point profiles at Baseline and Week 26: n=inhaled human insulin, insulin glargine.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Secondary

Change From Baseline in Lipids at Week 26

Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with lipids data at Baseline and Week 26: n=inhaled human insulin, insulin glargine.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26

CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (hs-CRP, leptin, and spot urine microalbumin) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.

Posted

Mean

Standard Deviation

mg/L

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26

CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (adiponectin and ApoB) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.

Posted

Mean

Standard Deviation

mg/mL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26

24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.

FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts

Secondary

Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26

SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts

Secondary

Number of Subjects With Hypoglycemic Events

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.

Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.

Posted

Number

participants

Months 1 to 7

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Number of Total Hypoglycemic Events

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.

Posted

Number

events

Months 1 to 7

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Number of Total Subject Months of Treatment

Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.

Posted

Number

subject months

Months 1 to 7

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts

Secondary

Crude Hypoglycemic Event Rate

crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.

Posted

Number

events / subject-months

Months 1 to 7

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Number of Nocturnal Hypoglycemic Events

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.

Safety population=all subjects who took at least 1 dose of study drug.

Posted

Number

events

Months 1 to 7

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight at Week 26

Body weight value: Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with body weight measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.

Posted

Mean

Standard Deviation

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Mass Index (BMI) at Week 26

BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with BMI measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.

Posted

Mean

Standard Deviation

kg/m2

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire

Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.

Not Posted

Baseline, Week 26

Participants

Other Pre-specified

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS

HbA1c lab value: Change = value at Week 26 minus value at Baseline.

FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Using the FAS yielded supplemental analyses for the primary efficacy endpoint.

Posted

Mean

Standard Deviation

percent

Baseline, Week 26

ID	Title	Description
OG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
OG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.			9		177
EG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.			4		142

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected212 at risk EG0011 affected190 at risk
Angina unstable	Cardiac disorders		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Cardiovascular disorder	Cardiac disorders		Systematic Assessment	EG0000 affected212 at risk EG0011 affected190 at risk
Palpitations	Cardiac disorders		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Pancreatitis	Gastrointestinal disorders		Systematic Assessment	EG0002 affected212 at risk EG0010 affected190 at risk
Chest pain	General disorders		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Hepatitis A	Infections and infestations		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Sepsis	Infections and infestations		Systematic Assessment	EG0000 affected212 at risk EG0011 affected190 at risk
Ankle fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Transient ischaemic attack	Nervous system disorders		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Nephrolithiasis	Renal and urinary disorders		Systematic Assessment	EG0001 affected212 at risk EG0010 affected190 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders		Systematic Assessment	EG0000 affected212 at risk EG0011 affected190 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG00014 affected212 at risk EG0016 affected190 at risk
Diarrhoea	Gastrointestinal disorders		Systematic Assessment	EG00012 affected212 at risk EG0018 affected190 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG00021 affected212 at risk EG00115 affected190 at risk
Asthenia	General disorders		Systematic Assessment	EG00028 affected212 at risk EG00117 affected190 at risk
Fatigue	General disorders		Systematic Assessment	EG00013 affected212 at risk EG00111 affected190 at risk
Injection site haematoma	General disorders		Systematic Assessment	EG0000 affected212 at risk EG00113 affected190 at risk
Oedema peripheral	General disorders		Systematic Assessment	EG00011 affected212 at risk EG0019 affected190 at risk
Influenza	Infections and infestations		Systematic Assessment	EG0009 affected212 at risk EG00110 affected190 at risk
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG00012 affected212 at risk EG00113 affected190 at risk
Upper respiratory tract infection	Infections and infestations		Systematic Assessment	EG00023 affected212 at risk EG00129 affected190 at risk
Weight increased	Investigations		Systematic Assessment	EG00017 affected212 at risk EG0019 affected190 at risk
Hypoglycaemia	Metabolism and nutrition disorders		Systematic Assessment	EG000144 affected212 at risk EG00183 affected190 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG00040 affected212 at risk EG00129 affected190 at risk
Headache	Nervous system disorders		Systematic Assessment	EG00029 affected212 at risk EG00117 affected190 at risk
Tremor	Nervous system disorders		Systematic Assessment	EG00067 affected212 at risk EG00143 affected190 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00018 affected212 at risk EG0016 affected190 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00035 affected212 at risk EG00121 affected190 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

ID	Title	Description
BG000	Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
BG001	Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
BG002	Total	Total of all reporting groups