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

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ClinicalTrials.gov Identifier: NCT01445951

Recruitment Status : Completed

First Posted : October 4, 2011

Results First Posted : October 22, 2014

Last Update Posted : October 22, 2014

Sponsor:

Information provided by (Responsible Party):

Mannkind Corporation

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Type 1 Diabetes Mellitus
Interventions:	Drug: Technosphere® Insulin with MedTone C Inhaler Drug: Technosphere ®Insulin with Gen2 Inhaler Drug: Insulin Aspart in combination with a basal insulin

Participant Flow

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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

Baseline Characteristics

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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)

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Other Pre-specified:

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

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9. Other Pre-specified:

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

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10. Other Pre-specified:

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

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11. Other Pre-specified:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: MannKind Corporation
phone: 201-983-5000
e-mail: aboss@mannkindcorp.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. doi: 10.2337/dc15-0075. Epub 2015 Jul 15.

Responsible Party:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT01445951 History of Changes
Other Study ID Numbers:	MKC-TI-171
First Submitted:	September 30, 2011
First Posted:	October 4, 2011
Results First Submitted:	July 22, 2014
Results First Posted:	October 22, 2014
Last Update Posted:	October 22, 2014

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