Inhaled preprandial human insulin with the AERx® iDMS versus subcutaneous injected insulin aspart in subjects with diabetes and chronic obstructive pulmonary disease: A 52-week, open-label, multicentre, randomised, parallel trial to investigate long-term safety

Phase 1

• Conditions: Type 1 DiabetesType 2 DiabetesCOPD; MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2006-004731-29-SK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-18
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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.Able and willing to perform self-monitoring of plasma glucose according to the protocol and able to keep a diary
3.Diagnosis of type 1 or type 2 diabetes, i.e.:
•Type 1 diabetes with an HbA1c = 11.0 % and treated continuously with basal/bolus insulin for at least six months or
•Type 2 diabetes with an HbA1c = 11.0 % and treated continuously with basal/bolus insulin for at least three months or
•Type 2 diabetes with an HbA1c = 7.5% and = 11.0 % and treated continuously with basal insulin (with or without an OAD(s) (except rosiglitazone if not approved in combination with insulin) for at least two months or
•Type 2 diabetes with an HbA1c = 7.5% and = 11.0 % and treated continuously with one or more OADs (except rosiglitazone if not approved in combination with insulin) for at least two months
4.Willing to continue on previous antidiabetic treatment
5.Males and females, age = 30 years
6.Body Mass Index (BMI) = 40 kg/m2
7.Clinical diagnosis of stable COPD. The COPD is limited to GOLD stages I-III (see protocol for classification table) and the exact classification is performed by the local pulmonary clinic also responsible for the PFT measurements.

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.Participated in another clinical trial and received an investigational drug within the last 4 weeks
2.Previous treatment with inhaled insulin (other than AERx for more than a total of seven days)
3.Previous participation in this trial. Participation is defined as randomisation
4.Current regular smoking or regular smoking within the last six months (regular smoking is defined as one cigarette or an equivalent amount of smoking tobacco per day or a positive urine cotinine test on laboratory test, except if resulting from non-inhaled tobacco products)
5.Chest X-ray with clinical significant pulmonary abnormalities (excluding changes of COPD) as evaluated by a radiologist
6.Unresolved symptoms and signs of an upper respiratory tract infection (URTI) within 3 weeks prior to screening or a current lower respiratory tract infection
7.Current or past history of acute or chronic pulmonary disease (excluding COPD - GOLD stage I-III) including asthma, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary fibrosis, lung cancer or a need for long-term oxygen therapy (= 15 hours/day)
8.Treatment with systemic steroid within 4 weeks prior to screening
9.Known alpha-1-antitrypsin deficiency
10.Positive screening for Hepatitis B antigen or Hepatitis C antibody or HIV
11.Clinically significant, active (or over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genitourinary, hematological systems
12.Creatinine = 2 mg/dL (=180 µmol/L))
13.Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
14.Proliferative retinopathy or maculopathy requiring acute treatment
15.Total daily insulin dosage > 100 IU or U per day
16.History of hypoglycaemia unawareness and/or recurrent severe hypoglycaemia with more than 2 severe episodes in the past year
17. Females of childbearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive
methods. Acceptable methods are: diaphragm, condom (by partner), intrauterine device in place for the last three months before trial start,
sponge, cap with spermicide, contraceptive path, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the
last three months before trial start, post menopausal state or sterilisation or as required by local law or practice
18.Impaired liver function, defined as screening aspartate amino transferase (AST) or alanine amino transferase (ALT) =2.5 times upper normal range (one retest analysed at the central laboratory within one week is permitted with the last sample being conclusive)
19.Known or suspected allergy to the trial products or related products
20.Current addiction to alcohol or substances of abuse as determined by the Investigator
21.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the trial
22.Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results

Study & Design

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