A mono-center, open label, randomised 2-period crossover study to compare the pharmacokinetics and pharmacodynamics of continuous insulin infusion administered either intradermally or subcutaneously in subjects with type 1 diabetes mellitus

• Conditions: Type 1 diabetes mellitus; MedDRA version: 12.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2009-016164-36-DE
• Lead Sponsor: Becton, Dickinson and Company, BD Technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: • Determine the pharmacodynamic (PD) effect of the infused insulin as measured by time to glucose rebound following discontinuation of test insulin infusion.<br>• Assess the safety and tolerability of intradermally infused insulin over a 24 hr period<br>• Assess the feasibility of the RCS for longer-term ID infusion<br>;Primary end point(s): The primary endpoint will be the PK response to changes in rapid-acting insulin infusion rate.