Trial · NCT00308308
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
NCT00308308, Phase 3, Completed, Mannkind Corporation; results first posted 2014-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes. Trials, record NCT00308308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00308308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
- NCT number
- NCT00308308
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 589 participants, actual
- Lead sponsor
- Mannkind Corporation
- Conditions
- Diabetes, Type I
- Interventions
- Technosphere Insulin, Active comparator
- First posted
- 2006-03-29
- Last updated
- 2014-10-16
- Results first posted
- 2014-10-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare the Mean Change From Baseline to Week 52 in HbA1c | Baseline to Week 52 | |
| Secondary | Change From Baseline in Weight to Week 52 | Baseline to Week 52 | Change from baseline in weight at Week 52 |
| Secondary | Change From Baseline in Fasting Plasma Glucose to Week 52 | Baseline to Week 52 | Change from baseline in fasting plasma glucose at Week 52 |
| Secondary | Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% | Baseline to Week 52 | Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0% |
| Secondary | Incidence of Total Hypoglycemia | Baseline to Week 52 | Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms. |
| Secondary | Incidence of Severe Hypoglycemia | Baseline to Week 52 | 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. |
| Secondary | Total Hypoglycemia Event Rate | Baseline to Week 52 | Number of Hypoglycemic Events/Total Subject Exposure Time (in months) |
| Secondary | Severe Hypoglycemia Event Rate | Baseline to Week 52 | Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Compare the Mean Change From Baseline to Week 52 in HbA1c | Baseline to Week 52 | Intention to treat (ITT) with Last Observation Carried Forward (LOCF) | Percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weight to Week 52 | Baseline to Week 52 | participants in ITT population with available data | kilogram | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose to Week 52 | Baseline to Week 52 | participants in ITT population with available data | mg/dl | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% | Baseline to Week 52 | participants in ITT population with available data | Participants | NUMBER |
| SECONDARY | Incidence of Total Hypoglycemia | Baseline to Week 52 | Safety population | percentage of participants | NUMBER |
| SECONDARY | Incidence of Severe Hypoglycemia | Baseline to Week 52 | Safety Population | percentage of participants | NUMBER |
| SECONDARY | Total Hypoglycemia Event Rate | Baseline to Week 52 | Safety Population | Number of events/subject-month | NUMBER |
| SECONDARY | Severe Hypoglycemia Event Rate | Baseline to Week 52 | Safety Population | Number of events/subject-month | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Compare the Mean Change From Baseline to Week 52 in HbA1c | TI + Insulin Glargine | -0.13 | Standard Error 0.058 | Percentage | |
| Compare the Mean Change From Baseline to Week 52 in HbA1c | Insulin Aspart + Insulin Glargine | -0.37 | Standard Error 0.059 | Percentage | |
| Change From Baseline in Weight to Week 52 | TI + Insulin Glargine | -0.5 | Standard Error 0.32 | kilogram | |
| Change From Baseline in Weight to Week 52 | Insulin Aspart + Insulin Glargine | 1.4 | Standard Error 0.30 | kilogram | |
| Change From Baseline in Fasting Plasma Glucose to Week 52 | TI + Insulin Glargine | -46.5 | Standard Error 5.61 | mg/dl | |
| Change From Baseline in Fasting Plasma Glucose to Week 52 | Insulin Aspart + Insulin Glargine | -25.7 | Standard Error 5.23 | mg/dl | |
| Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% | TI + Insulin Glargine | 33 | Participants | ||
| Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% | Insulin Aspart + Insulin Glargine | 35 | Participants | ||
| Incidence of Total Hypoglycemia | TI + Insulin Glargine | 85.67 | percentage of participants | ||
| Incidence of Total Hypoglycemia | Insulin Aspart + Insulin Glargine | 92.28 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TI + Insulin Glargine | 301 | |
| Overall Study | STARTED | Insulin Aspart + Insulin Glargine | 288 | |
| Overall Study | COMPLETED | TI + Insulin Glargine | 198 | |
| Overall Study | COMPLETED | Insulin Aspart + Insulin Glargine | 220 | |
| Overall Study | NOT COMPLETED | TI + Insulin Glargine | 103 | |
| Overall Study | NOT COMPLETED | Insulin Aspart + Insulin Glargine | 68 |
Source ClinicalTrials.gov
Adverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | TI + Insulin Glargine | 98 | 293 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Insulin Aspart + Insulin Glargine | 21 | 272 | |
| other | Headache | Nervous system disorders | TI + Insulin Glargine | 16 | 293 | |
| other | Headache | Nervous system disorders | Insulin Aspart + Insulin Glargine | 15 | 272 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | TI + Insulin Glargine | 252 | 293 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Insulin Aspart + Insulin Glargine | 252 | 272 | |
| other | Influenza | Infections and infestations | TI + Insulin Glargine | 23 | 293 | |
| other | Influenza | Infections and infestations | Insulin Aspart + Insulin Glargine | 19 | 272 | |
| other | Nasopharyngitis | Infections and infestations | TI + Insulin Glargine | 37 | 293 | |
| other | Nasopharyngitis | Infections and infestations | Insulin Aspart + Insulin Glargine | 38 | 272 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TI + Insulin Glargine | ||
| Total, all-cause mortality | Insulin Aspart + Insulin Glargine | ||
| Total, other adverse events | TI + Insulin Glargine | 265 | 293 |
| Total, other adverse events | Insulin Aspart + Insulin Glargine | 257 | 272 |
| Total, serious adverse events | TI + Insulin Glargine | 52 | 293 |
| Total, serious adverse events | Insulin Aspart + Insulin Glargine | 47 | 272 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TI + Insulin Glargine vs Insulin Aspart + Insulin Glargine: Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% | Trial comparisons |
| TI + Insulin Glargine vs Insulin Aspart + Insulin Glargine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00308308
GET https://conductscience.org/api/trials/v1/NCT00308308/events?page=2