Phase 3
N=353
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01451398 ↗Enrolled (actual)
353
Serious AEs
4.0%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline to Week 24 in HbA1c — -0.82; -0.42 percentage of hemoglobin — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Technosphere® Insulin (Drug); Technosphere Powder (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mannkind Corporation
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in HbA1c |
-0.82; -0.42 | <0.0001 sig |
| SECONDARY Proportion of Responders Achieving HbA1c <= 7.0% |
37.7; 19.0 | 0.0005 sig |
| SECONDARY Proportion of Responders Achieving HbA1c <= 6.5% |
15.9; 4.2 | 0.0021 sig |
| SECONDARY FPG Change From Baseline to Week 24 |
-11.20; -3.78 | 0.1698 |
| SECONDARY Proportion of Subjects Requiring Rescue Therapy |
6.8; 9.7 | — |
| SECONDARY Time to Rescue |
95; 85 | — |
| SECONDARY FEV1 Change From Baseline to Week 24 |
-0.13; -0.04 | — |
| SECONDARY Incidence of Total Hypoglycemia |
67.8; 30.7 | — |
| SECONDARY Incidence of Severe Hypoglycemia |
5.1; 1.7 | — |
| SECONDARY Total Hypoglycemia Event Rate |
1.16; 0.50 | <0.0001 sig |
| SECONDARY Severe Hypoglycemia Event Rate |
2.37; 0.60 | 0.2024 |
| SECONDARY Mean 7-point Glucose Baseline Values |
178.5; 182.2; 212.8; 219.9; 176.7; 183.6 | — |
| SECONDARY Mean 7-point Glucose Week 24 Values |
156.6; 160.9; 170.3; 194.7; 152.4; 163.4 | — |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
0.49; -1.13 | <0.0001 sig |
Summary
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.
Eligibility Criteria
Inclusion Criteria
- HbA1c > or = to 7.5% and or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
- Forced vital capacity (FVC) > or = to 70% NHANES III predicted
- Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) > or = to NHANES III lower limit of normal (LLN)
Exclusion Criteria
- History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
- Any clinically significant radiological findings on screening chest x-ray
- Use of medications for asthma, COPD, or any other chronic respiratory conditions
- Evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)
- Renal disease or renal dysfunction
- Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease
- Previous or current use of amiodarone
- Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening
- History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
- History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements
Data sourced from ClinicalTrials.gov (NCT01451398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.