Comparison of Technosphere®/Insulin, Insulin Lispro and Exubera® Effect on Endogenous Glucose Production After a Meal Challenge and During a Euglycemic Glucose Clamp Procedure in Subjects with Type 2 Diabetes

• Conditions: Type 2 diabetes mellitus.; MedDRA version: 9.1Level: PTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2006-004489-15-DE
• Lead Sponsor: MannKind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible subjects must meet all of the following inclusion criteria:
1.Males and females = 18 and = 70 years of age;
2.Clinical diagnosis of type 2 diabetes mellitus for = 12 months;
3.Receiving diabetes treatment with insulin for a minimum of 3 months;
4.Body Mass Index (BMI) of = 34 kg/m2 and = 25 kg/m2;
5.HbA1c = of 8.5% based upon results from a central laboratory;
6.PFTs:
•An FEV1 to FVC ratio = 70% and an FVC = 80%;
• Amendment 1: FEV1 = 70% predicted; FEV1/FVC ratio = 70%
•Single-breath carbon monoxide diffusing capacity (DLco uncorrected) = 70% of Predicted (Miller)
7.Urine cotinine of = 100ng/dL
8.Be willing to sign a written Informed Consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Total daily insulin requirement of = 1.2 U/kg body weight;
2. Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks;
3. Two or more severe hypoglycemic episodes within 6 months of screening;
4. Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening;
5. Severe complications of diabetes
6. Previous exposure to any inhaled insulin product;
7. Currently using an insulin delivery pump;
8. Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial or a history of hypersensitivity to Technosphere®/Placebo, T/I or to drugs with a similar chemical structure;
9. Any clinically important pulmonary disease, confirmed by documented history,
pulmonary function testing, or radiologic findings;
10. Chronic use of systemic steroids;
11. Inability to perform PFT maneuvers to meet the recommended ATS standards of acceptability and repeatability;
12. Significant improvement in spirometry following bronchodilation defined as at least 12% and a 200 mL increase in either the FVC or the FEV1;
13. Active respiratory infection; however, the subject may return for Screening, Visit 1, after 30 days from resolution of the respiratory condition.
14. Clinically significant major organ system disease such as:
- Seizure disorder;
- Significant cardiovascular dysfunction and/or history within 3 months of Screening,
such as congestive heart failure (NYHA Class III or IV; Appendix B) or serious
arrhythmia (Amiodarone is an exclusionary medication), myocardial infarction,
cardiac surgery, recurrent syncope, transient ischemic attacks or cerebrovascular
accident;
- Uncontrolled hypertension with a systolic blood pressure of >160 mm Hg and/or
diastolic blood pressure > 95 mm Hg at screening, despite pharmacologic treatment;
- Clinical nephrotic syndrome or renal dysfunction or disease, serum creatinine
> 2.0 mg/dL in males and > 1.8 mg/dL in females and/or Blood Urea Nitrogen (BUN)
> 50 mg/dL;
- Cancer (other than an excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms;
- 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] and/or gamma glutamyl-transferase [GGT] = 3x Upper Limit
of Normal (ULN);
- Active infection eg, Human Immunodeficiency Virus (HIV), Hepatitis, or history of
severe infection within 30 days of Visit 1 (Screening);
- Anemia (hemoglobin value below lower limit of normal);
- A previous diagnosis of systemic autoimmune or collagen vascular disease requiring
prior or current treatment with systemic corticosteroids, cytotoxic drugs or
penicillamine;
- Any concurrent illness, other than diabetes mellitus and mild COPD, not controlled
by a stable therapeutic regime as judged by the investigator;
15. Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity;
16. Clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the Medical Monitor);
17. Female subjects who are pregnant, lactating or planning to become pregnant during the clinical trial period;
18. Female subjects of childbearing potential (defined as pre-menopausal and not surgically sterilized or post-menopausal for less than 2 years) not practicing adequate birth control.
19. Current drug or alcohol abuse, or a history of drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified