Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes | NCT00308308

Official Title

A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

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
1	Experimental	Technosphere Insulin	Drug: Technosphere Insulin
2	Active Comparator	Rapid-acting analogue insulin plus basal insulin glargine	Drug: Active comparator

Name	Type	Description	Arm Group Labels	Other Names
Technosphere Insulin	Drug	Inhalation, 15U/30U	1
Active comparator

Outcomes Module

Measure	Description	Time Frame
Compare the Mean Change From Baseline to Week 52 in HbA1c		Baseline to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Weight to Week 52	Change from baseline in weight at Week 52	Baseline to Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52	Change from baseline in fasting plasma glucose at Week 52

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Clinical Research Inc		Mobile	Alabama	36608	United States
Radiant Research (Phoenix)

Results Section

Participant Flow Module

ID	Title	Description
FG000	TI + Insulin Glargine	TI + Insulin glargine
FG001	Insulin Aspart + Insulin Glargine	Comparator

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.

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
	BG00037.9± 13.06 BG00138.1± 13.18 BG00238± 13.11

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000139 BG001132 BG002

HbA1c

Glycosylated Hemoglobin

Mean

Standard Deviation

percent

Title

Denominators

Categories

Title	Measurements
	BG0008.4± 0.95 BG0018.5± 0.97 BG002

Weight

Weight in kilograms

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00076.7± 15.64 BG00176.8± 14.95 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

Compare the Mean Change From Baseline to Week 52 in HbA1c

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

Posted

Least Squares Mean

Standard Error

Percentage

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000277 OG001262

Title

Denominators

Categories

Title	Measurements
	OG000-0.13± 0.058 OG001-0.37± 0.059

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		ANCOVA				Mean Difference (Final Values)	0.24	Standard Error of the Mean	0.082	2-Sided	95	0.08	0.40				Yes	Non-Inferiority or Equivalence	Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in > 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.

Secondary

Change From Baseline in Weight to Week 52

Change from baseline in weight at Week 52

participants in ITT population with available data

Posted

Least Squares Mean

Standard Error

kilogram

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Plasma Glucose to Week 52

Change from baseline in fasting plasma glucose at Week 52

participants in ITT population with available data

Posted

Least Squares Mean

Standard Error

mg/dl

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Secondary

Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%

Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%

participants in ITT population with available data

Posted

Number

Participants

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Secondary

Incidence of Total Hypoglycemia

Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.

Safety population

Posted

Number

percentage of participants

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Secondary

Incidence of Severe Hypoglycemia

Severe hypoglycemia occurs when all 3 of the following occur simultaneously:

Subject requires the assistance of another person;
Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);
Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,
Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.

Safety Population

Posted

Number

percentage of participants

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Secondary

Total Hypoglycemia Event Rate

Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

Safety Population

Posted

Number

Number of events/subject-month

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Secondary

Severe Hypoglycemia Event Rate

Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

Safety Population

Posted

Number

Number of events/subject-month

Baseline to Week 52

ID	Title	Description
OG000	TI + Insulin Glargine	TI + Insulin glargine
OG001	Insulin Aspart + Insulin Glargine	Comparator

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TI + Insulin Glargine	TI + Insulin glargine			52	293	265	293
EG001	Insulin Aspart + Insulin Glargine	Comparator			47	272	257	272

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Angina pectoris	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Angina unstable	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0012 affected272 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Cellulitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0011 affected272 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0005 affected293 at risk EG0010 affected272 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Gastritis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0012 affected272 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Hepatocellular damage	Hepatobiliary disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG00030 affected293 at risk EG00134 affected272 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0002 affected293 at risk EG0014 affected272 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0003 affected293 at risk EG0010 affected272 at risk
Localised infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Loss of consciousness	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG0008 affected293 at risk EG0017 affected272 at risk
Metabolic syndrome	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Myocardial infarction	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Pelvic abscess	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Pilonidal cyst	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Rectal abscess	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0012 affected272 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Staphylococcal infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Systematic Assessment	EG0000 affected293 at risk EG0011 affected272 at risk
Vomiting	Gastrointestinal disorders	MedDRA 7.1	Systematic Assessment	EG0001 affected293 at risk EG0010 affected272 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG00098 affected293 at risk EG00121 affected272 at risk
Headache	Nervous system disorders	MedDRA 7.1	Systematic Assessment	EG00016 affected293 at risk EG00115 affected272 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Systematic Assessment	EG000252 affected293 at risk EG001252 affected272 at risk
Influenza	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG00023 affected293 at risk EG00119 affected272 at risk
Nasopharyngitis	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG00037 affected293 at risk EG00138 affected272 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Systematic Assessment	EG00016 affected293 at risk EG0016 affected272 at risk
Pulmonary function test decreased	Investigations	MedDRA 7.1	Systematic Assessment	EG00016 affected293 at risk EG0014 affected272 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Systematic Assessment	EG00046 affected293 at risk EG00141 affected272 at risk

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

ID	Title	Description
BG000	TI + Insulin Glargine	TI + Insulin glargine
BG001	Insulin Aspart + Insulin Glargine	Comparator
BG002	Total	Total of all reporting groups