E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus type 1 and type 2 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | Diabetes mellitus |
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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 clinical trial is to examine the effects of inhaled prandial T/I plus subjects’ modified anti-diabetic treatments compared to the subjects’ unmodified anti-diabetic treatments on lung function and pulmonary safety with respect to post bronchodilator FEV1 measurements at monthly Pulmonary Function Laboratory visits. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare inhaled prandial T/I plus subjects’ modified anti-diabetic treatments with subjects’ unmodified pre-clinical trial anti-diabetic treatments, with respect to: (a) Frequency of Asthma Exacerbations (b) Asthma Control Questionnaire (ACQ) (c) Changes in daily Peak Expiratory Flow (PEF) measurements and (d) other safety and tolerability outcomes. (Change from baseline to Month 12 in HbA1c as a measure of glycemic control; Hypoglycemic events; Hyperglycaemic events; Clinically significant changes in ECG measurements; Changes in LDL and HDL cholesterol levels; Clinically significant changes in chest X-rays); Change in PEF at 10 and 60 minutes Post T/Placebo from Pre T/Placebo; Change in PEF at 10 and 60 minutes Post T/I from Pre T/I (in T/I group only). . |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria include: Nonsmoking males or females aged >/= 18 years with a clinical diagnosis of type 1 or 2 diabetes for at least 1 year, receiving a stable regimen of insulin therapy alone or in combination with oral anti-hyperglycemic agents, HbA1c >/= 6.0% to </= 11.5% and body mass index </= 40 kg/m2. A clinical diagnosis of Step 1 to 3 asthma with: 1) FEV1 > 60% predicted, 2) A significant improvement following bronchodilator at Visit 1 (defined as at least 12% AND at least 200 mL increase in either the FEV1 or FVC); OR documented positive bronchoprovocation study. All subjects must also exhibit a DLco (uncorrected) of >/= 70% of predicted, a total lung capacity (TLC) of >/= 80% of predicted and must exhibit </= 30% variability in Peak Expiratory Flow Rate measurements taken during the 2-week, run-in period.
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E.4 | Principal exclusion criteria |
Key exclusion criteria include: total daily insulin requirement >/= 1.4 U/kg, Step 4 asthma, severe secondary complications of diabetes (eg, symptomatic autonomic neuropathy, advanced nephropathy, proliferative retinopathy, severe peripheral vascular disease), other clinically significant disease or cancer within the last 5 years (other than excised cutaneous basal cell carcinoma), females who are pregnant, lactating, or who plan on becoming pregnant. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is to compare the mean change from baseline to Month 12 in post bronchodilator values of FEV1 between treatment groups.
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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 | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Usual antidiabetic treatment medication. |
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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 | 20 |
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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30 days post last patient last visit. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |