Phase 3
Completed N=677
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
Diabetes Type 2
Source: ClinicalTrials.gov NCT00309244 ↗
Enrolled (actual)
677
Serious AEs
10.4%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in HbA1c to Week 52 — -0.59; -0.71 percent
Summary
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c to Week 52 |
-0.59; -0.71 | — |
| SECONDARY Change From Baseline in Weight to Week 52 |
0.9; 2.5 | 0.0002 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose to Week 52 |
-35.7; -17.9 | 0.0029 sig |
| SECONDARY Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% |
47; 65 | 0.2793 |
| SECONDARY Incidence of Total Hypoglycemia |
47.99; 68.58 | <0.001 sig |
| SECONDARY Incidence of Severe Hypoglycemia |
4.33; 9.97 | 0.0066 sig |
| SECONDARY Total Hypoglycemia Event Rate |
0.41; 0.61 | 0.0027 sig |
| SECONDARY Severe Hypoglycemia Event Rate |
0.73; 2.20 | 0.0591 |
Eligibility Criteria
Inclusion Criteria
- Men or women ≥ 18 and ≤ 80 years old
- Clinical diagnosis of type 2 diabetes mellitus
- HbA1c > 7.0% and ≤ 11.0%
- BMI ≤ 40 kg/m2
- Negative smoking status and urine cotinine test
- Written informed consent
- Receiving sc insulin 2-3 times daily administered as any of the following 3 regimens: self-mix regimen, pre-mix regimen, or long-acting analogue and regular or rapid-acting insulin analogue not to exceed 3 daily injections. Subjects may also have received oral antidiabetic agents including metformin or thiazolidinediones.
- No dose adjustments for insulin and oral antidiabetic agents within the preceding 6 weeks.
- FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted
Exclusion Criteria
- Total daily dose of insulin ≥1.4 IU/kg body weight
- Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks
- Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide [Byetta®]) within the preceding 8 weeks
- Unstable diabetes mellitus control, defined as 2 or more episodes of severe hypoglycemia (requiring third party intervention) and/or any hospitalization or emergency room visit due to poor diabetic control or hyperglycemia requiring hospitalization within the preceding 6 months
- Exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial
- Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the investigational drug or to drugs of similar chemical structures
- History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST)and/or alanine aminotransferase (ALT) ≥ 3 x Upper Limit of Normal (ULN)(Includes active hepatitis A, positive hepatitis B and/or hepatitis C serology)
- Serum creatinine > 1.8 mg/dL in women and > 2.0 mg/dL in men History of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings
- Congestive heart disease graded as class III or class IV according to New York Heart Association criteria and subjects currently being treated pharmacologically for ventricular dysrhythmias using amiodarone
- History of myocardial infarction, cardiac surgery, coronary angioplasty, and/or stroke within the preceding 3 months
- Symptomatic coronary artery disease, including crescendo angina, unstable angina, and/or unstable or symptomatic cardiac arrhythmias
- Poorly controlled arterial hypertension despite pharmacologic treatment, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 110 mm Hg at screening
- History of malignancy within the preceding 5 years (other than excised basal cell carcinoma of the skin), any history of lung neoplasm, and/or subjects with current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
- History of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), or positive human immunodeficiency virus (HIV) serology
- Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
- Visit 1/Screening (Week -3), but prior to Visit 1 PFTs and before Visit 3/Baseline (Week 0), subject will be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin and urine β-HCG (for women of childbearing potential age only) will be required
- Women who are pregnant, lactating or planning to become pregnant
- Women of childbearing potential (defined as pre-menopausal and not surgically ster
Data sourced from ClinicalTrials.gov (NCT00309244). 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. Informational only — not medical advice.