E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
The primary objective of the study is to compare the pharmacodynamic effect (PD) (= glucose infusion rates necessary to keep blood glucose constant) induced by identical insulin infusion rates with two different insulin pumps, which are designed with different regulation of insulin delivery. |
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E.2.2 | Secondary objectives of the trial |
As secondary objectives the pharmacokinetic (PK) properties will be evaluated, i.e. measurement of serum insulin (regular human insulin, insulin Lispro) and Free Fatty Acids (FFA). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male patients will be included in the trial only, if they fulfill all of the inclusion criteria mentioned below:· Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)· Type 1 Diabetes mellitus, according to clinical judgement / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20)· Current treatment: Intensified insulin therapy (also patients on continuous subcutaneous insulin infusion (CSII)) (max. total daily insulin dose <1.2 U/kg)· Age in the range of >18 and <65 years· Body mass index (BMI) <32 kg/m²·HbA1c <9.0 %Able and willing to adhere to the study procedures for the entire trial period· Negative test results for hepatitis C antibodies or hepatitis B surface antigen or HIV at screening. |
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E.4 | Principal exclusion criteria |
Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:·Previous participation in this trial or participation in a clinical trial within 4 weeks prior to screening examination.· Proliferative retinopathy or maculopathy that has required acute treatment within the last six months·Acute and severe illness apart from diabetes mellitus as judged by the investigator·Abnormalities in the laboratory parameters if judged as clinically significant by the investigator (GOT / GPT> 2*ULN; creatinine clearance (Cockroft formula) <50 ml/h). In particular, patients with thrombocyte count <100/nL, INR >1.3, PTT >50 sec. will not be permitted to enter the study.· Clinically significant abnormalities in the ECG·Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator· Use of systemic corticoids for the last three month prior screening examination or treatment with medication known to interfere with glucose metabolism such as non-selective ß-blockers, or mono amine oxidase (MAO) inhibitors, ACE-inhibitors or thiazides, unless medical treatment having existed for at least three month prior screening examination.· Impaired hepatic or renal functions as judged by the investigator·Cardiac problems as judged by the investigator· Uncontrolled hypertension (treated or untreated) as judged by the investigator (RRsyst. >140 mmHg, RRdiast. > 90 mmHg)· Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation·Current addiction to alcohol or substances of abuse as determined by the investigator·Allergy to plaster.·Any other condition that the investigator feels would interfere with trial participation or evaluation of results |
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E.5 End points |
E.5.1 | Primary end point(s) |
According to the objective of this study, namely to investigate the PD and PK effects of different s.c. insulin Lispro infusion rates delivered with two different insulin pumps, the following calculations shall be performed:· Mean GIR in the last 120 min of each of the four 4 h infusion periods (primary variable)·AUCs under the glucose infusion rate (GIR) profiles for each of the four 4 h periods with a given infusion rate (secondary variable)· Mean serum insulin levels in the last 120 min of each of the four 4 h infusion periods (secondary variable)· AUCs under the serum insulin profiles for each of the four 4 h periods with a given infusion rate (secondary variable)In order to subtract the metabolic effect induced by the i.v. infusion of regular human insulin the average GIR in the two hours prior to the start of the s.c. insulin Lispro infusion shall be calculated and subtracted from all subsequent GIR values (baseline correction).The data obtained with the two pumps shall be analyzed by means a paired t-test. The null hypothesis is that no significant differences in these variables with the two pumps will be observed. Both insulin pumps are on the market and have a CE mark. The insulin formulations used are approved drugs. The insulin infusion rates used are well within the therapeutic range. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
s.c administration of IMP using 2 different insulin pumps (Accu-Chek Spirit vs. Paradigm 522/722) |
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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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |