Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
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| ClinicalTrials.gov Identifier: NCT00137046 |
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Recruitment Status :
Terminated
(See termination reason in detailed description.)
First Posted : August 29, 2005
Results First Posted : January 26, 2010
Last Update Posted : February 18, 2010
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Sponsor:
Pfizer
Information provided by:
Pfizer
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Type 1 |
| Interventions |
Drug: Subcutaneous Insulin Drug: Inhaled Insulin |
| Enrollment | 582 |
Participant Flow
| Recruitment Details | A total of 64 centers took part in the study between 09 May 2002 and 08 December 2008. |
| Pre-assignment Details | At the screening visit and during the 4-week run-in phase all subjects received a subcutaneous insulin regimen consisting of 2 to 3 doses per day of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 doses daily of intermediate-/long-acting insulin (NPH insulin or Ultralente), or insulin glargine once daily at bedtime. |
| Arm/Group Title | Inhaled Insulin | Subcutaneous Insulin |
|---|---|---|
 Arm/Group Description |
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin. | Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin. |
| Period Title: Overall Study | ||
| Started | 291 [1] | 291 [2] |
| Received Study Treatment | 290 | 290 |
| Completed | 192 [3] | 198 |
| Not Completed | 99 | 93 |
| Reason Not Completed | ||
| Death | 2 | 1 |
| Adverse Event | 16 | 5 |
| Laboratory Abnormality | 2 | 0 |
| Lack of Efficacy | 13 | 1 |
| Lost to Follow-up | 8 | 24 |
| Other | 23 | 19 |
| Withdrawal by Subject | 33 | 42 |
| Adverse Event 4 Days after Last Dose | 1 | 0 |
| Withdrew prior to study treatment | 1 | 1 |
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[1]
One subject was randomized to inhaled insulin but never received treatment.
[2]
One subject was randomized to subcutaneous insulin but never received treatment.
[3]
Completed subjects were those subjects who did not discontinue while on active drug.
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Baseline Characteristics
| Arm/Group Title | Inhaled Insulin | Subcutaneous Insulin | Total | |
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Arm/Group Description |
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin. | Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 290 | 290 | 580 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Years |
Number Analyzed | 290 participants | 290 participants | 580 participants |
| 18 to 25 | 48 | 53 | 101 | |
| 26 to 35 | 81 | 96 | 177 | |
| 36 to 45 | 94 | 71 | 165 | |
| 46 to 55 | 52 | 48 | 100 | |
| 56 to 65 | 15 | 22 | 37 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 290 participants | 290 participants | 580 participants | |
| Female |
121 41.7%
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129 44.5%
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250 43.1%
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| Male |
169 58.3%
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161 55.5%
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330 56.9%
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