E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 objectives of this study are:
1. To evaluate and compare changes in pulmonary function as measured by forced expiratory volume in one second (FEV1)
2. To compare the incidence of a decrease in FEV1 of greater than or equal to 15%. (This threshold is chosen to exceed the measurement variability originating from technical and biological factors).
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
1. To evaluate and compare the change in forced vital capacity (FVC), total lung capacity (TLC) and single –breath carbon monoxide diffusing capacity of the lung (DLco).
2. To evaluate the incidence of a decrease in FVC or TLC of greater than or equal to 15%, or a decrease in DLco of greater than or equal to 3 mL CO/min/mm Hg.
3. To evaluate and compare glycemic control, expressed as the percent of glycosylated hemoglobin A1c (HbA1c) between the 2 diabetes treatment groups and to evaluate and compare the incidence and frequency of defined hypoglycaemia between the 2 diabetes groups.
4. To evaluate and compare changes in lung function between subjects with diabetes and subjects without abnormalities in glucose metabolism.
5. To compare changes in diabetes treatment groups as a function of baseline glycemic control.
Other objectives will be to identify nontreatment related factors that are linked to decreases in pulmonary function. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Non smoking males or females aged 18 to 80 years and body mass index <42 kg/m2, an FEV1 greater than or equal to 70% of predicted, a DLco greater than or equal to 70% and TLC greater than or equal to 80% of predicted at screening and no abnormalities in screening pulmonary radiology. Subjects with diabetes mellitus: type 1 or type 2 diabetes for at least 2 years and a HbA1c greater than or equal to 6.6% and less than or equal to 12.0%. Subjects without abnormalities in glucose control: no history of diabetes, normal results from a formal glucose tolerance test.
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E.4 | Principal exclusion criteria |
History of chronic obstructive pulmonary disease (COPD), asthma, other significant pulmonary disease or sleep apnea; significant renal, hepatic, or cardiac disease; women who are pregnant, lactating, or planning on becoming pregnant; and subjects who have participated in studies of other investigational drugs within the previous 3 months. Subjects with diabetes mellitus: no severe complications of diabetes (eg symptomatic autonomic neuropathy; disabling peripheral neuropathy; proliferative retinopathy, nephropathy with renal failure, renal transplant and/or dialysis; foot ulcers; nontraumatic amputations; and/or vascular claudication) |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Mean changes in FEV1 from baseline and decreases from baseline greater than or equal to 15%. |
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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 | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Identification of non-treatment related factors linked to decreases in pulmonary function |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 | Yes |
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. Each patient has their last visit to the hospital and is followed up approximately one month after this with a telephone call |
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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 |