Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient enrolled Sept 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 week Screening Period prior to run-in (basal insulin optimization period). 1401 Screened / 621 Eligible of which 614 entered the run-in period. 538 met randomization criteria at end of run-in of which 518 were randomized.

Reporting Groups

	Description
Technosphere Insulin-Gen2 + Basal Insulin	Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Technosphere Insulin-MedTone + Basal Insulin	Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Insulin Aspart + Basal Insulin	Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient

Participant Flow:   Overall Study

	Technosphere Insulin-Gen2 + Basal Insulin	Technosphere Insulin-MedTone + Basal Insulin	Insulin Aspart + Basal Insulin
STARTED	174	174	170
COMPLETED	130	138	151
NOT COMPLETED	44	36	19
Adverse Event	16	9	0
Protocol Violation	2	2	2
Withdrawal by Subject	21	16	8
Physician Decision	3	1	0
Lost to Follow-up	1	2	4
Pregnancy	0	1	4
Death	0	0	1
Non-compliance with study drug	1	2	0
Non-compliance with protocol	0	1	0
Sponsor decision - subject travel	0	1	0
Cough	0	1	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

	Description
Technosphere Insulin-Gen2 + Basal Insulin	Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Technosphere Insulin-MedTone + Basal Insulin	Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Insulin Aspart + Basal Insulin	Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
Total	Total of all reporting groups

Baseline Measures

	Technosphere Insulin-Gen2 + Basal Insulin	Technosphere Insulin-MedTone + Basal Insulin	Insulin Aspart + Basal Insulin	Total
Overall Participants Analyzed  [Units: Participants]	174	174	170	518
Age, Customized  [Units: Participants]
18-30 years	56	48	46	150
31-49 years	93	84	88	265
50-64 years	18	33	28	79
>= 65 years	7	9	8	24
Gender  [Units: Participants]
Female	97	94	96	287
Male	77	80	74	231
Ethnicity (NIH/OMB)  [Units: Participants]
Hispanic or Latino	17	22	18	57
Not Hispanic or Latino	157	152	152	461
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB)  [Units: Participants]
American Indian or Alaska Native	0	0	0	0
Asian	1	1	0	2
Native Hawaiian or Other Pacific Islander	1	0	0	1
Black or African American	8	5	3	16
White	164	167	166	497
More than one race	0	0	0	0
Unknown or Not Reported	0	1	1	2
Region of Enrollment  [Units: Participants]
United States	71	69	67	207
Brazil	14	15	13	42
Ukraine	44	38	38	120
Russian Federation	45	52	52	149
Duration of Diabetes  [Units: Years] Mean (Full Range)	16.0   (1.1 to 57.3)	17.7   (1.1 to 49.5)	16.7   (1.0 to 42.2)	16.8   (1.0 to 57.3)
Weight  [Units: Kg] Mean (Full Range)	75.7   (41.7 to 129.4)	76.8   (47.6 to 124.0)	72.6   (46.6 to 120.2)	75.1   (41.7 to 129.4)
BMI  [Units: Kg/m^2] Mean (Full Range)	26.0   (16.6 to 38.6)	26.2   (18.1 to 36.4)	25.4   (17.4 to 37.2)	25.9   (16.6 to 38.6)
Fasting Plasma Glucose  [Units: mg/dL] Mean (Full Range)	155.0   (21.0 to 403.0)	144.3   (43.0 to 358.0)	151.2   (23.0 to 375.0)	150.2   (21.0 to 403.0)
HbA1c  [Units: Percent of hemoglobin] Mean (Full Range)	7.98   (6.20 to 10.60)	8.00   (6.10 to 10.20)	7.88   (5.80 to 10.10)	7.95   (5.80 to 10.60)

1.  Primary:

Change From Baseline to Week 24 in HbA1c   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:

FEV1 Change From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]

3.  Secondary:

FPG Change From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:

Mean 7-point Glucose Baseline Values   [ Time Frame: Baseline ]

5.  Secondary:

Mean 7-point Glucose Week 24 Values   [ Time Frame: Week 24 ]

6.  Secondary:

Change in Body Weight From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]

7.  Secondary:

Proportion of Responders Achieving HbA1c <= 7.0%   [ Time Frame: Week 24 ]

8.  Other Pre-specified:

Incidence of Total Hypoglycemia   [ Time Frame: Baseline to Week 24 ]

9.  Other Pre-specified:

Incidence of Severe Hypoglycemia   [ Time Frame: Baseline to Week 24 ]

10.  Other Pre-specified:

Total Hypoglycemia Event Rate   [ Time Frame: Baseline to Week 24 ]

11.  Other Pre-specified:

Severe Hypoglycemia Event Rate   [ Time Frame: Baseline to Week 24 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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