A One Year Clinical Trial Assessing the Usefulness and Sa... | NCT00138671

A One Year Clinical Trial Assessing the Usefulness and Sa... | NCT00138671 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Subcutaneous Insulin	Active Comparator		Drug: Subcutaneous Insulin
Inhaled Insulin	Experimental		Drug: Inhaled Insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous Insulin	Drug	Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).	Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)	DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).	Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

Secondary Outcomes

Measure	Description	Time Frame
Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)	Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.	Duration of the study

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Glendale	Arizona	85306	United States
Pfizer Investigational Site

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
FG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Death		FG0000 subjects FG0013 subjects
Adverse Event		FG0006 subjects FG0013 subjects
Lost to Follow-up		FG0001 subjects FG0012 subjects
Withdrawal by Subject		FG0003 subjects FG0015 subjects
Other		FG0003 subjects FG0013 subjects

Arm/Group Information

ID	Title	Description
BG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
BG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
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, Customized

Number

participants

Title

Denominators

Categories

36 to 45 years

Title	Measurements
	BG0001 BG0013 BG0024

46 to 55 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG0019 BG002

Primary Diagnosis (Diabetes Type I or II)

Type I or Type II diabetes mellitus was defined using the American Diabetes Association criteria (2002).

Number

participants

Title

Denominators

Categories

Type I

Title	Measurements
	BG0007 BG0016 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 in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).

Full Analysis Set (FAS), FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.

Posted

Mean

Standard Deviation

Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG00059 OG00143

Title

Denominators

Categories

Week 1 (n=52, 39)

Title	Measurements
	OG000-0.021± 0.132 OG001-0.018± 0.125

Week 2 (n=51, 40)

Title	Measurements
	OG000

Secondary

Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)

Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

Posted

Number

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)

Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

Posted

Number

mL/min/mmHg

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Primary

Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)

DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).

FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.

Posted

Mean

Standard Deviation

mL/min/mmHg

Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Other PFTs (Besides FEV1 and DLco)

Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.

Posted

Number

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Bronchodilator Responsiveness as Determined by the Change in FEV1

Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.

Posted

Mean

Standard Deviation

percent change

Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Insulin Dose Responsiveness for FEV1

FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).

Posted

Mean

Standard Deviation

Baseline, Week 9, Week 51

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Insulin Dose Responsiveness for DLco

DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).

FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had a FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.

Posted

Mean

Standard Deviation

mL/min/mmHg

Baseline, Week 9, Week 51

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Methacholine PC20

Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.

Posted

Number

mg/mL

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used

All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.

Posted

Number

puffs

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Posted

Number

events/subject-month (crude event rate)

0 to 1 week to > 9 months

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Incidence of Severe COPD Exacerbations

Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Posted

Number

events/subject-month (crude event rate)

0 to 1 week to > 9 months

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires

The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.

Posted

Number

grade

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).

FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.

Posted

Mean

Standard Deviation

percent

Baseline, Weeks 6, 12, 26, 39, and 52

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Plasma Glucose

Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).

Posted

Mean

Standard Deviation

mg/dL

Baseline, Weeks 6, 12, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Weight

Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).

FAS, HbA1c=randomized subjects with >=1 study drug dose, baseline and >=1 post-baseline HbA1c measurement. Last Observation Carried Forward (LOCF) method used. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin. Week 11 and 50 visits were part of the methacholine substudy and were not required visits for all subjects.

Posted

Mean

Standard Deviation

Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)

Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.

FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.

Posted

Mean

Standard Deviation

Units

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin
OG001	Subcutaneous Insulin

Units	Counts
Participants	OG000

Secondary

Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)

Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.

Posted

Mean

Standard Deviation

mg, Units

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin
OG001	Subcutaneous Insulin

Units	Counts
Participants	OG000

Secondary

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)

Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).

Posted

Mean

Standard Deviation

Units/kg

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin
OG001	Subcutaneous Insulin

Units	Counts
Participants	OG000

Secondary

Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)

Posted

Mean

Standard Deviation

mg/kg, Units/kg

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

ID	Title	Description
OG000	Inhaled Insulin
OG001	Subcutaneous Insulin

Units	Counts
Participants	OG000

Secondary

Lipids

Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.

Posted

Number

mg/dL

Duration of the study

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants	OG000

Secondary

Hypoglycemic Event Rates

A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Posted

Number

events / subject-month

0 to1 month to > 11 months

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Secondary

Severe Hypoglcyemic Event Rates

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 or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Posted

Number

events / 100 subject-months

0 to 1 month to > 11 months

ID	Title	Description
OG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
OG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.			17		59
EG001	Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.			14		38

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Angina unstable	Cardiac disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Coronary artery disease	Cardiac disorders		Systematic Assessment	EG0000 affected59 at risk EG0012 affected46 at risk
Myocardial infarction	Cardiac disorders		Systematic Assessment	EG0001 affected59 at risk EG0013 affected46 at risk
Inguinal hernia	Gastrointestinal disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Intestinal obstruction	Gastrointestinal disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Vomiting projectile	Gastrointestinal disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Chest pain	General disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Hypothermia	General disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Ill-defined disorder	General disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Implant site erosion	General disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Appendicitis	Infections and infestations		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Cellulitis	Infections and infestations		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Gastroenteritis viral	Infections and infestations		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Osteomyelitis	Infections and infestations		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Pneumonia	Infections and infestations		Systematic Assessment	EG0003 affected59 at risk EG0010 affected46 at risk
Postoperative wound infection	Infections and infestations		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Drug administration error	Injury, poisoning and procedural complications		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Radius fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Rib fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Wrist fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Electrocardiogram abnormal	Investigations		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Troponin increased	Investigations		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Dehydration	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Hypoglycaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected59 at risk EG0011 affected46 at risk
Ketoacidosis	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Depressed level of consciousness	Nervous system disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Neuropathy peripheral	Nervous system disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Syncope	Nervous system disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Azotaemia	Renal and urinary disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Bladder neck obstruction	Renal and urinary disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected59 at risk EG0010 affected46 at risk
Arteriosclerosis	Vascular disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk
Hypertension	Vascular disorders		Systematic Assessment	EG0000 affected59 at risk EG0011 affected46 at risk
Hypotension	Vascular disorders		Systematic Assessment	EG0001 affected59 at risk EG0010 affected46 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (v12.0)	Systematic Assessment	EG0004 affected59 at risk EG0011 affected46 at risk
Coronary artery disease	Cardiac disorders		Systematic Assessment	EG0002 affected59 at risk EG0013 affected46 at risk
Myocardial infarction	Cardiac disorders		Systematic Assessment	EG0001 affected59 at risk EG0013 affected46 at risk
Vision blurred	Eye disorders		Systematic Assessment	EG0002 affected59 at risk EG0014 affected46 at risk
Constipation	Gastrointestinal disorders		Systematic Assessment	EG0003 affected59 at risk EG0010 affected46 at risk
Diarrhoea	Gastrointestinal disorders		Systematic Assessment	EG0004 affected59 at risk EG0013 affected46 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0004 affected59 at risk EG0014 affected46 at risk
Toothache	Gastrointestinal disorders		Systematic Assessment	EG0003 affected59 at risk EG0011 affected46 at risk
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG0003 affected59 at risk EG0013 affected46 at risk
Asthenia	General disorders		Systematic Assessment	EG0009 affected59 at risk EG0015 affected46 at risk
Chest pain	General disorders		Systematic Assessment	EG0004 affected59 at risk EG0011 affected46 at risk
Fatigue	General disorders		Systematic Assessment	EG0006 affected59 at risk EG0013 affected46 at risk
Oedema peripheral	General disorders		Systematic Assessment	EG0005 affected59 at risk EG0016 affected46 at risk
Seasonal allergy	Immune system disorders		Systematic Assessment	EG0003 affected59 at risk EG0010 affected46 at risk
Bronchitis	Infections and infestations		Systematic Assessment	EG0008 affected59 at risk EG0012 affected46 at risk
Gastroenteritis	Infections and infestations		Systematic Assessment	EG0003 affected59 at risk EG0010 affected46 at risk
Gastroenteritis viral	Infections and infestations		Systematic Assessment	EG0002 affected59 at risk EG0013 affected46 at risk
Influenza	Infections and infestations		Systematic Assessment	EG0004 affected59 at risk EG0012 affected46 at risk
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG00010 affected59 at risk EG0016 affected46 at risk
Otitis media	Infections and infestations		Systematic Assessment	EG0003 affected59 at risk EG0011 affected46 at risk
Pneumonia	Infections and infestations		Systematic Assessment	EG0004 affected59 at risk EG0012 affected46 at risk
Sinusitis	Infections and infestations		Systematic Assessment	EG0003 affected59 at risk EG0012 affected46 at risk
Upper respiratory tract infection	Infections and infestations		Systematic Assessment	EG00012 affected59 at risk EG0016 affected46 at risk
Urinary tract infection	Infections and infestations		Systematic Assessment	EG0004 affected59 at risk EG0011 affected46 at risk
Contusion	Injury, poisoning and procedural complications		Systematic Assessment	EG0003 affected59 at risk EG0012 affected46 at risk
Hypoglycaemia	Metabolism and nutrition disorders		Systematic Assessment	EG00040 affected59 at risk EG00130 affected46 at risk
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0007 affected59 at risk EG0012 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0005 affected59 at risk EG0015 affected46 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0002 affected59 at risk EG0015 affected46 at risk
Myalgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected59 at risk EG0013 affected46 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0003 affected59 at risk EG0013 affected46 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG0008 affected59 at risk EG0017 affected46 at risk
Headache	Nervous system disorders		Systematic Assessment	EG00010 affected59 at risk EG0013 affected46 at risk
Neuropathy peripheral	Nervous system disorders		Systematic Assessment	EG0004 affected59 at risk EG0013 affected46 at risk
Tremor	Nervous system disorders		Systematic Assessment	EG0004 affected59 at risk EG0015 affected46 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0004 affected59 at risk EG0014 affected46 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0005 affected59 at risk EG0012 affected46 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0006 affected59 at risk EG0012 affected46 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0003 affected59 at risk EG0010 affected46 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0003 affected59 at risk EG0011 affected46 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0007 affected59 at risk EG0019 affected46 at risk
Hypertension	Vascular disorders		Systematic Assessment	EG0006 affected59 at risk EG0013 affected46 at risk

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Title

Denominators

Categories

Week 1 (n=51, 40)

Title	Measurements
	OG000-0.263± 1.610 OG001-0.319± 0.984

Week 2 (n=51, 40)

Title	Measurements
	OG000-0.491± 1.288 OG001-0.031± 1.106

Week 3 (n=47, 40)

Title	Measurements
	OG000-0.494± 1.175 OG0010.169± 1.303

Week 4 (n=50, 39)

Title	Measurements
	OG000-0.640± 1.345 OG001-0.482± 1.321

Week 6 (n=52, 38)

Title	Measurements
	OG000-0.625± 1.356 OG001-0.576± 1.226

Week 12 (n=47, 40)

Title	Measurements
	OG000-0.379± 1.516 OG001-0.534± 1.506

Week 18 (n=51, 36)

Title	Measurements
	OG000-0.287± 1.463 OG001-0.286± 1.796

Week 26 (n=52, 38)

Title	Measurements
	OG000-0.287± 1.841 OG001-0.947± 1.643

Week 39 (n=47, 33)

Title	Measurements
	OG000-0.611± 1.475 OG001-0.891± 2.137

Week 52 (n=45, 29)

Title	Measurements
	OG000-0.614± 1.754 OG001-0.882± 1.720

Title

Denominators

Categories

Week 1 (n=52, 39)

Title	Measurements
	OG0004.890± 5.727 OG0015.693± 7.249

Week 2 (n=51, 40)

Title	Measurements
	OG0006.132± 6.200 OG0015.245± 6.254

Week 3 (n=47, 40)

Title	Measurements
	OG0006.346± 7.469 OG0015.820± 8.347

Week 4 (n=50, 38)

Title	Measurements
	OG0005.177± 7.211 OG0016.382± 9.685

Week 6 (n=53, 38)

Title	Measurements
	OG0005.988± 6.034 OG0017.736± 10.139

Week 12 (n=48, 41)

Title	Measurements
	OG0006.473± 8.994 OG0015.542± 6.791

Week 18 (n=52, 37)

Title	Measurements
	OG0006.700± 6.020 OG0015.152± 8.155

Week 26 (n=52, 38)

Title	Measurements
	OG0005.585± 5.592 OG0015.856± 8.562

Week 39 (n=47, 34)

Title	Measurements
	OG0006.634± 5.829 OG0016.098± 9.311

Week 52 (n=45, 30)

Title	Measurements
	OG0006.030± 4.700 OG0015.445± 8.390

Title

Denominators

Categories

Baseline, 10 minutes (n=50, 39)

Title	Measurements
	OG0000.009± 0.076 OG0010.022± 0.106

Baseline, 60 minutes (n=50, 39)

Title	Measurements
	OG000-0.004± 0.096 OG0010.020± 0.127

Week 9, 10 minutes (n=42, 31)

Title	Measurements
	OG000-0.004± 0.110 OG0010.016± 0.096

Week 9, 60 minutes (n=42, 30)

Title	Measurements
	OG0000.011± 0.109 OG0010.030± 0.116

Week 51, 10 minutes (n=46, 31)

Title	Measurements
	OG000-0.021± 0.121 OG001-0.002± 0.084

Week 51, 60 minutes (n=45, 31)

Title	Measurements
	OG0000.005± 0.115 OG001-0.020± 0.141

Title

Denominators

Categories

Baseline, 10 minutes (n=48, 39)

Title	Measurements
	OG000-0.461± 1.157 OG001-0.195± 0.707

Baseline, 60 minutes (n=49, 39)

Title	Measurements
	OG000-0.597± 1.102 OG001-0.160± 1.217

Week 9, 10 minutes (n=41, 30)

Title	Measurements
	OG000-0.182± 1.015 OG001-0.238± 1.505

Week 9, 60 minutes (n=42, 29)

Title	Measurements
	OG0000.013± 2.288 OG001-0.373± 1.574

Week 51, 10 minutes (n=44, 31)

Title	Measurements
	OG000-0.465± 0.781 OG0010.054± 1.204

Week 51, 60 minutes (n=44, 31)

Title	Measurements
	OG000-0.395± 0.885 OG001-0.163± 1.211

Title

Denominators

Categories

0 to 1 week (n=59, 43)

Title	Measurements
	OG0000.00 OG0010.00

> 1 to 2 weeks (n=59, 43)

Title	Measurements
	OG0000.07 OG0010.00

> 2 to 3 weeks (n=59, 43)

Title	Measurements
	OG0000.00 OG0010.00

> 3 to 4 weeks (n=59, 42)

Title	Measurements
	OG0000.07 OG0010.10

> 4 to 6 weeks (n=57, 42)

Title	Measurements
	OG0000.08 OG0010.05

> 6 to 9 weeks (n=56, 42)

Title	Measurements
	OG0000.05 OG0010.03

> 9 to 12 weeks (n=55, 41)

Title	Measurements
	OG0000.05 OG0010.07

> 3 to 6 months (n=52, 41)

Title	Measurements
	OG0000.02 OG0010.01

> 6 to 9 months (n=52, 37)

Title	Measurements
	OG0000.01 OG0010.01

> 9 months (n=50, 35)

Title	Measurements
	OG0000.01 OG0010.02

Overall (n=59, 43)

Title	Measurements
	OG0000.02 OG0010.02

Title

Denominators

Categories

0 to 1 week (n=59, 43)

Title	Measurements
	OG0000.00 OG0010.00

> 1 to 2 weeks (n=59, 43)

Title	Measurements
	OG0000.00 OG0010.00

> 2 to 3 weeks (n=59, 43)

Title	Measurements
	OG0000.00 OG0010.00

> 3 to 4 weeks (n=59, 42)

Title	Measurements
	OG0000.00 OG0010.00

> 4 to 6 weeks (n=57, 42)

Title	Measurements
	OG0000.00 OG0010.00

> 6 to 9 weeks (n=56, 42)

Title	Measurements
	OG0000.00 OG0010.00

> 9 to 12 weeks (n=55, 41)

Title	Measurements
	OG0000.00 OG0010.00

> 3 to 6 months (n=52, 41)

Title	Measurements
	OG0000.00 OG0010.00

> 6 to 9 months (n=52, 37)

Title	Measurements
	OG0000.01 OG0010.00

> 9 months (n=50, 35)

Title	Measurements
	OG0000.00 OG0010.00

Overall (n= 59, 43)

Title	Measurements
	OG0000.00 OG0010.00

Title

Denominators

Categories

Week 6 (n=56, 40)

Title	Measurements
	OG000-0.40± 0.81 OG001-0.48± 0.60

Week 12 (n=50, 41)

Title	Measurements
	OG000-0.53± 0.98 OG001-0.42± 0.65

Week 26 (n=52, 38)

Title	Measurements
	OG000-0.39± 0.96 OG001-0.32± 0.79

Week 39 (n=48, 35)

Title	Measurements
	OG000-0.34± 1.11 OG001-0.20± 1.01

Week 52 (n=46, 32)

Title	Measurements
	OG000-0.30± 1.10 OG001-0.23± 0.84

Week 52 LOCF (n=57, 43)

Title	Measurements
	OG000-0.28± 1.03 OG001-0.26± 0.79

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 6	Mean Difference (Final Values)	0.10	90	-0.17	0.36	No	Superiority or Other
OG000 OG001	Week 12	Mean Difference (Final Values)	-0.01	90	-0.27	0.26	No	Superiority or Other
OG000 OG001	Week 26	Mean Difference (Final Values)	-0.02	90	-0.29	0.26	No	Superiority or Other
OG000 OG001	Week 39	Mean Difference (Final Values)	-0.08	90	-0.36	0.20	No	Superiority or Other
OG000 OG001	Week 52	Mean Difference (Final Values)	0.06	90	-0.23	0.35	No	Superiority or Other
OG000 OG001	Week 52 LOCF	Mean Difference (Final Values)	0.01	90	-0.29	0.31	No	Superiority or Other

Title

Denominators

Categories

Week 6 (n=52, 39)

Title	Measurements
	OG000-24.67± 69.69 OG0012.89± 41.17

Week 12 (n=48, 39)

Title	Measurements
	OG000-30.73± 52.99 OG001-0.18± 46.25

Week 26 (n=47, 38)

Title	Measurements
	OG000-34.92± 61.63 OG00110.45± 62.80

Week 39 (n=47, 33)

Title	Measurements
	OG000-20.45± 56.62 OG00110.43± 98.53

Week 52 (n=45, 31)

Title	Measurements
	OG000-23.40± 65.77 OG00112.37± 58.01

Week 52 (LOCF) (n=57, 43)

Title	Measurements
	OG000-28.55± 65.85 OG0012.36± 66.51

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 6	Mean Difference (Final Values)	-4.475	90	-23.47	14.518	No	Superiority or Other
OG000 OG001	Week 12	Mean Difference (Final Values)	-10.91	90	-30.04	8.232	No	Superiority or Other
OG000 OG001	Week 26	Mean Difference (Final Values)	-22.84	90	-42.51	-3.166	No	Superiority or Other
OG000 OG001	Week 39	Mean Difference (Final Values)	-8.222	90	-28.52	12.075	No	Superiority or Other
OG000 OG001	Week 52	Mean Difference (Final Values)	-8.329	90	-29.27	12.616	No	Superiority or Other
OG000 OG001	Week 52 LOCF	Mean Difference (Final Values)	1.406	90	-13.70	16.514	No	Superiority or Other

Title

Denominators

Categories

Week 1 (n=52, 40)

Title	Measurements
	OG0000.25± 1.62 OG0010.02± 0.98

Week 2 (n=51, 40)

Title	Measurements
	OG0000.26± 1.77 OG0010.15± 1.73

Week 3 (n=49, 41)

Title	Measurements
	OG0000.19± 2.03 OG0010.13± 1.90

Week 4 (n=53, 41)

Title	Measurements
	OG0000.19± 1.98 OG0010.24± 2.13

Week 6 (n=54, 39)

Title	Measurements
	OG0000.42± 2.26 OG0010.26± 1.94

Week 9 (n=47, 34)

Title	Measurements
	OG0000.31± 2.93 OG0010.25± 2.31

Week 11 (n=8, 8)

Title	Measurements
	OG0000.03± 2.25 OG001-0.14± 2.97

Week 12 (n=49, 41)

Title	Measurements
	OG0000.42± 3.29 OG0010.34± 3.69

Week 18 (n=52, 37)

Title	Measurements
	OG0000.40± 3.66 OG0010.90± 4.01

Week 26 (n=52, 38)

Title	Measurements
	OG0000.85± 3.95 OG0011.99± 4.03

Week 39 (n=47, 34)

Title	Measurements
	OG0000.61± 4.37 OG0012.43± 5.21

Week 50 (n=8, 6)

Title	Measurements
	OG0001.75± 4.90 OG0016.33± 9.06

Week 51 (n=23, 17)

Title	Measurements
	OG0001.21± 4.82 OG0012.67± 3.28

Week 52 (n=43, 27)

Title	Measurements
	OG0000.97± 5.65 OG0013.32± 4.68

Week 52 LOCF (n=59, 43)

Title	Measurements
	OG0000.99± 4.20 OG0012.40± 4.79

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 1	Mean Difference (Final Values)	0.884	90	-0.317	2.084	No	Superiority or Other
OG000 OG001	Week 2	Mean Difference (Final Values)	0.470	90	-0.728	1.668	No	Superiority or Other
OG000 OG001	Week 3	Mean Difference (Final Values)	0.382	90	-0.815	1.579	No	Superiority or Other
OG000 OG001	Week 4	Mean Difference (Final Values)	0.405	90	-0.793	1.602	No	Superiority or Other
OG000 OG001	Week 6	Mean Difference (Final Values)	0.562	90	-0.642	1.766	No	Superiority or Other
OG000 OG001	Week 9	Mean Difference (Final Values)	0.416	90	-0.809	1.641	No	Superiority or Other
OG000 OG001	Week 11	Mean Difference (Final Values)	0.019	90	-1.416	1.454	No	Superiority or Other
OG000 OG001	Week 12	Mean Difference (Final Values)	0.091	90	-1.127	1.308	No	Superiority or Other
OG000 OG001	Week 18	Mean Difference (Final Values)	-0.309	90	-1.551	0.934	No	Superiority or Other
OG000 OG001	Week 26	Mean Difference (Final Values)	-0.869	90	-2.123	0.384	No	Superiority or Other
OG000 OG001	Week 39	Mean Difference (Final Values)	-1.664	90	-2.968	-0.360	No	Superiority or Other
OG000 OG001	Week 50	Mean Difference (Final Values)	-2.116	90	-3.829	-0.403	No	Superiority or Other
OG000 OG001	Week 51	Mean Difference (Final Values)	-1.801	90	-3.204	-0.397	No	Superiority or Other
OG000 OG001	Week 52	Mean Difference (Final Values)	-2.026	90	-3.384	-0.668	No	Superiority or Other
OG000 OG001	Week 52 LOCF	Mean Difference (Final Values)	-1.451	90	-3.003	0.101	No	Superiority or Other

Title

Denominators

Categories

Week 1 (n=53, 40)

Title	Measurements
	OG00043.78± 22.20 OG00148.18± 23.44

Week 2 (n=50, 41)

Title	Measurements
	OG00044.96± 22.50 OG00148.04± 24.33

Week 3 (n=51, 39)

Title	Measurements
	OG00047.04± 24.36 OG00150.53± 24.44

Week 4 (n=52, 41)

Title	Measurements
	OG00047.50± 25.94 OG00150.30± 25.61

Week 6 (n=54, 40)

Title	Measurements
	OG00049.56± 26.61 OG00151.34± 25.91

Week 9 (n=47, 35)

Title	Measurements
	OG00048.68± 28.61 OG00156.72± 25.89

Week 12 (n=51, 41)

Title	Measurements
	OG00049.23± 28.46 OG00152.32± 29.49

Week 18 (n=51, 40)

Title	Measurements
	OG00050.87± 29.32 OG00153.83± 29.34

Week 26 (n=51, 38)

Title	Measurements
	OG00050.47± 28.83 OG00155.78± 28.11

Week 39 (n=49, 35)

Title	Measurements
	OG00049.99± 29.00 OG00153.10± 26.11

Week 52 (n=48, 34)

Title	Measurements
	OG00050.66± 30.63 OG00153.39± 26.32

Title

Denominators

Categories

Week 1 (n=54, 40)

Title	Measurements
	OG00012.34± 5.26 OG00132.74± 21.59

Week 2 (n=51, 41)

Title	Measurements
	OG00013.03± 6.63 OG00132.08± 22.25

Week 3 (n=52, 39)

Title	Measurements
	OG00014.10± 6.89 OG00132.88± 21.60

Week 4 (n=53, 41)

Title	Measurements
	OG00014.17± 7.28 OG00131.85± 22.29

Week 6 (n=55, 40)

Title	Measurements
	OG00015.17± 7.20 OG00133.42± 22.72

Week 9 (n=48, 35)

Title	Measurements
	OG00015.82± 7.41 OG00136.65± 22.94

Week 12 (n=52, 41)

Title	Measurements
	OG00015.64± 7.80 OG00133.58± 23.94

Week 18 (n=52, 40)

Title	Measurements
	OG00016.47± 7.48 OG00135.36± 26.06

Week 26 (n=52, 38)

Title	Measurements
	OG00016.71± 8.05 OG00137.73± 26.14

Week 39 (n=49, 35)

Title	Measurements
	OG00017.22± 8.60 OG00137.47± 26.20

Week 52 (n=48, 34)

Title	Measurements
	OG00016.85± 9.52 OG00139.28± 25.13

Title

Denominators

Categories

Week 1 (n=51, 40)

Title	Measurements
	OG0000.46± 0.22 OG0010.48± 0.19

Week 2 (n=50, 40)

Title	Measurements
	OG0000.47± 0.22 OG0010.48± 0.20

Week 3 (n=49, 39)

Title	Measurements
	OG0000.50± 0.25 OG0010.50± 0.21

Week 4 (n=50, 41)

Title	Measurements
	OG0000.49± 0.26 OG0010.50± 0.21

Week 6 (n=53, 39)

Title	Measurements
	OG0000.52± 0.27 OG0010.51± 0.21

Week 9 (n=46, 34)

Title	Measurements
	OG0000.50± 0.29 OG0010.57± 0.21

Week 12 (n=49, 41)

Title	Measurements
	OG0000.51± 0.28 OG0010.52± 0.24

Week 18 (n=51, 37)

Title	Measurements
	OG0000.53± 0.29 OG0010.55± 0.24

Week 26 (n=51, 38)

Title	Measurements
	OG0000.52± 0.28 OG0010.55± 0.22

Week 39 (n=47, 34)

Title	Measurements
	OG0000.51± 0.27 OG0010.54± 0.24

Week 52, (n=43, 27)

Title	Measurements
	OG0000.52± 0.29 OG0010.56± 0.21

Title

Denominators

Categories

Week 1 (n=52, 40)

Title	Measurements
	OG0000.13± 0.05 OG0010.33± 0.21

Week 2 (n=51, 40)

Title	Measurements
	OG0000.14± 0.06 OG0010.33± 0.21

Week 3 (n=49, 39)

Title	Measurements
	OG0000.15± 0.07 OG0010.33± 0.22

Week 4 (n=51, 41)

Title	Measurements
	OG0000.15± 0.07 OG0010.32± 0.22

Week 6 (n=54, 39)

Title	Measurements
	OG0000.16± 0.07 OG0010.34± 0.22

Week 9 (n=47, 34)

Title	Measurements
	OG0000.17± 0.07 OG0010.36± 0.22

Week 12 (n=49, 41)

Title	Measurements
	OG0000.17± 0.08 OG0010.34± 0.23

Week 18 (n=52, 37)

Title	Measurements
	OG0000.17± 0.08 OG0010.37± 0.24

Week 26 (n=52, 38)

Title	Measurements
	OG0000.18± 0.08 OG0010.38± 0.24

Week 39 (n=47, 34)

Title	Measurements
	OG0000.18± 0.08 OG0010.38± 0.25

Week 52 (n=43, 27)

Title	Measurements
	OG0000.18± 0.09 OG0010.40± 0.25

Title

Denominators

Categories

0 to 1 month (n=57, 43)

Title	Measurements
	OG0001.76 OG0011.36

> 1 to 2 months (n=56, 42)

Title	Measurements
	OG0001.25 OG0010.98

> 2 to 3 months (n=55, 42)

Title	Measurements
	OG0001.21 OG0010.97

> 3 to 4 months (n=52, 41)

Title	Measurements
	OG0000.87 OG0010.67

> 4 to 5 months (n=52, 40)

Title	Measurements
	OG0000.96 OG0011.01

> 5 to 6 months (n=52, 38)

Title	Measurements
	OG0000.69 OG0011.13

> 6 to 7 months (n=52, 37)

Title	Measurements
	OG0000.62 OG0010.92

> 7 to 8 months (n=51, 36)

Title	Measurements
	OG0000.67 OG0010.75

> 8 to 9 months (n=51, 36)

Title	Measurements
	OG0000.59 OG0010.78

> 9 to 10 months (n=51, 36)

Title	Measurements
	OG0000.50 OG0010.52

> 10 to 11 months (n=49, 34)

Title	Measurements
	OG0000.75 OG0010.51

> 11 months (n=47, 33)

Title	Measurements
	OG0000.62 OG0010.26

Overall (n=57, 43)

Title	Measurements
	OG0000.89 OG0010.84

Title

Denominators

Categories

0 to 1 month (n=57, 43)

Title	Measurements
	OG0001.71 OG0012.35

> 1 to 2 months (n=56, 42)

Title	Measurements
	OG0001.79 OG0010.00

> 2 to 3 months (n=55, 42)

Title	Measurements
	OG0000.00 OG0010.00

> 3 to 4 months (n=52, 41)

Title	Measurements
	OG0000.00 OG0010.00

> 4 to 5 months (n=52, 40)

Title	Measurements
	OG0000.00 OG0010.00

> 5 to 6 months (n=52, 38)

Title	Measurements
	OG0000.00 OG0010.00

> 6 to 7 months (n=52, 37)

Title	Measurements
	OG0000.00 OG0010.00

> 7 to 8 months (n=51, 36)

Title	Measurements
	OG0000.00 OG0010.00

> 8 to 9 months (n=51, 36)

Title	Measurements
	OG0001.96 OG0010.00

> 9 to 10 months (n=51, 36)

Title	Measurements
	OG0002.01 OG0010.00

> 10 to 11 months (n=49, 34)

Title	Measurements
	OG0000.00 OG0010.00

> 11 months (n=47, 33)

Title	Measurements
	OG0000.00 OG0010.00

Overall (n=57, 43)

Title	Measurements
	OG0000.64 OG0010.22

ID	Term
D003920	Diabetes Mellitus
D029424	Pulmonary Disease, Chronic Obstructive