E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To study the patients with diabetes mellitus (type 1, 2 and 3c) and exocrine pancreatic insufficiency. |
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E.1.1.1 | Medical condition in easily understood language |
Different type of diabetes mellitus (type 1,2 3c) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 |
To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on glucose metabolism, nutritional parameters, incretin response and beta-cell function. |
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E.2.2 | Secondary objectives of the trial |
1. To prospectively study the prevalence of T3cDM. 2. To prospectively study the frequency of exocrine insufficiency in T1 and T2DM. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with type 1 and type 2 diabetes mellitus with a fecal elastase test <200 μg/g, between 18 and 80 years old and with signed inform consent will be recruited. Patients are randomized to receive either pancreatin (Panzytrat 25.000 Ph.Eur.E.) or placebo in a double-blind manner. Study medication is taken three times a day with the main meals (2 capsules of 25.000 Ph.Eur.E. pancreatin or placebo). Additionally, two or three snacks accompanied by intake of one capsule of 25.000 Ph.Eur.E. of pancreatin or placebo is allowed. |
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E.4 | Principal exclusion criteria |
- patients with any severe diseases - any type of malignancy - any history of gastrointestinal surgery, - any known reason for maldigestion or malabsorption - any history of alcohol or drug abuse - proven gastroparesis or diarrhea - females with existing or intended pregnancy or breast-feeding, or not using adequate birth control
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E.5 End points |
E.5.1 | Primary end point(s) |
To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on glucose metabolism, nutritional parameters, incretin response and beta-cell function. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before the start of the study drug and 4 and 8 weeks and 3 and 6 months afterwards. |
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E.5.2 | Secondary end point(s) |
1. To prospectively study the prevalence of T3cDM. 2. To prospectively study the frequency of exocrine insufficiency in T1 and T2DM. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |