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 | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To define the pharmacokinetic (PK) profile of initiation, rate change, and discontinuation of continuously infused insulin administered either intradermally or subcutaneously over multiple stepped infusion periods. |
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E.2.2 | Secondary objectives of the trial |
• Determine the pharmacodynamic (PD) effect of the infused insulin as measured by time to glucose rebound following discontinuation of test insulin infusion. • Assess the safety and tolerability of intradermally infused insulin over a 24 hr period • Assess the feasibility of the RCS for longer-term ID infusion
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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 subject) • Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year • Current treatment: Insulin Pump • Age in the range of ≥ 18 and ≤ 55 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, hepatitis B surface antigen and HIV at screening.
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E.4 | Principal exclusion criteria |
• Previous participation in this trial or participation in a clinical trial within 3 months prior screening examination • Any symptoms suggestive of, or a diagnosis or treatment for gastroparesis • Abnormalities in renal function (e.g. serum creatinine >1.2 mg/dl) or judged by the investigator that would pose a problem of clearance of injected insulin • 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. In particular, subjects with GOT/GPT >3x, 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 • Lipodystrophy which in the judgment of the investigator would pose a problem in terms of variability of absorption of injected insulin • 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 • Any disease requiring use of anti-coagulants • 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/adhesive • Any other condition that the investigator feels would interfere with trial participation or evaluation of results. • Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening • Subjects with a history of deep leg vein thrombosis or with frequent appearance of deep leg vein thrombosis in 1st degree relatives as judged by the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the PK response to changes in rapid-acting insulin infusion rate. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 |
evaluate the use of a commercially available insulin pump with the RCS for intradermal delivery |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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 |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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as provided in the protocol |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |