Inhaled pre-prandial human insulin with the AERx iDMS versus s.c. insulin aspart in type 2 diabetes A 52-week, open-label, multicentre, randomised trial followed by 52-week extension and 12-week re-randomised extension to investigate safety and efficacy - ND

• Conditions: Diabetes Mellitus; MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2005-005378-58-IT
• Lead Sponsor: OVO NORDISK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

6.2 Inclusion Criteria 1. Informed consent obtained before any trial-related activities Trial-related activities are any procedure that would not have been performed during normal management of the subject . 2. Diagnosis of type 2 diabetes according to clinical judgement 3. Current treatment with any regimen of insulin for 8805; 3 months with or without a maximum of one OAD 4. Able and willing to be treated with a basal regimen once or twice daily and bolus regimen 3 times per day 5. Males and females, age 8805; 18 years 6. Body mass index of BMI 8804; 40.0 kg/m2 7. HbA1c 8804; 11.0 analysis from central laboratory 8. Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
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. Previous participation in this trial. Participation is defined as randomisation 2. Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception appropriate methods include abstinence and the following methods diaphragm, condom, by partner , intrauterine device, sponge, spermacide or oral contraceptives 3. Total daily insulin dosage 100 Units 4. Current smoking or smoking within the last 6 months regular smoking defined as one cigarette or an equivalent amount of smoking tobacco per day or a positive urine cotinine test on screening laboratory test. Subjects using non-inhalable tobacco products can be included despite a positive urine cotinine test 5. Chest X-ray with any clinically significant abnormalities evaluated by a radiologist 6. Unresolved symptoms and signs of an upper respiratory tract infection URI within 3 weeks prior to screening 7. Current acute or chronic pulmonary disease excluding asthma including chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, sarcoidosis, and pulmonary fibrosis 8. Positive screening for Hepatitis B antigen or Hepatitis C antibody 9. Positive screening for Human Immune deficiency Virus HIV 10. History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator 11. Treatment with systemic steroids within the past 2 months prior to screening 12. Impaired hepatic function defined as screening aspartate aminotransferase AST or alanine aminotransferase ALT 8805; 2.5 times upper normal range one re-test analysed at the central laboratory within one week is permitted with the last sample being conclusive 13. Known or suspected allergy to any trial products or related products 14. Clinically significant, active or over the past 12 months disease of the cardiovascular, gastrointestinal, neurological, genitourinary, haematological systems, or has severe uncontrolled treated or untreated hypertension systolic blood pressure 8805; 180 mmHg or sitting diastolic blood pressure 8805; 100 or history of proliferative retinopathy or maculopathy requiring treatment 15. Renal insufficiency creatinine 8805; 2 mg/dL; 8805; 180 mol/L 16. Any conditions that the Investigator judges would interfere with trial participation or evaluation of results 17. Current addiction to alcohol or substances of abuse as judged by the Investigator 18. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the trial 19. Participated in another clinical trial and received an investigational drug within the last 4 weeks or received previous treatment with pulmonary insulin other than subjects treated with AERx for more than a total of seven days

Study & Design

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