E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes Type 2 Diabetes COPD |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this trial is to evaluate the long term pulmonary safety profiles comparing preprandial inhaled human insulin with preprandial subcutaneous (s.c.) injections of insulin aspart, both in combination with basal insulin and/or OADs, in subjects with diabetes and COPD. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare the two treatments with respect to: •Long term safety profiles as measured by laboratory parameters, ECG, funduscopy/ fundusphotography, body weight, vital signs, physical examination and adverse events. •Incidence of hypoglycaemic episodes •Glycaemic control as measured by HbA1c and fasting plasma glucose (FPG) •Patient reported outcomes (PRO) •Bolus insulin doses
and further to: •Evaluate the number and type of AERx® iDMS complaints
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
•Change in PFTs (Forced Expiratory Volume during the first second (FEV1), Forced Expiratory Volume during the first six seconds (FEV6), Forced Vital Capacity (FVC), Forced Residual Capacity (FRC), Residual Volume (RV), Total Lung Capacity (TLC), and Diffusion Capacity (DL,CO)) as percent of predicted value from baseline to 52 weeks of treatment •Distribution of overall classification of COPD according to GOLD classification at end of 52 weeks of treatment •Type and frequency of inhaled and systemic medication for pulmonary symptomatology (COPD medication) during 52 weeks of treatment •Type, duration and frequency of COPD exacerbations, both severe (hospitalisation) and non-severe, (systemic steroids, antibiotics) during 52 weeks of treatment •Change in X-ray from baseline to 52 weeks of treatment
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |