A mono center, open-label, randomized study examining the effects of intra-dermal vs. subcutaneous application of regular human insulin or rapid-acting insulin analogue on postprandial glycemic excursions in patients with type 1 diabetes
- Conditions
- The study will be performed in Type 1 Diabetics
- Registration Number
- EUCTR2007-003924-39-DE
- Lead Sponsor
- Becton, Dickinson and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 30
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 judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year, and less than 15 years
·Current treatment: Intensified insulin therapy (MDI or CSII)
·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?
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)
F.1.3.1 Number of subjects for this age range
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 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, patients 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is the assessment of the postprandial glycemic excursions after a standardized meal while the prandial insulin requirements are covered by applying different types of insulin ID or SC. ;Secondary Objective: In addition, safety will be investigated by the analysis of the following:<br>Adverse events (AEs) <br>Serious adverse events (SAEs)<br>;Primary end point(s): The primary endpoint is the Area Under Curve (AUC) of the blood glucose (BG) profile in the 90 minutes after the meal (BG-AUC0-1.5 h) with and without baseline correction. For baseline correction the mean BG in the last 60 min before t= 0 min will be calculated and subtracted from all subsequent values. Because of the possibility that postprandial BG values may fall below baseline resulting in negative values, all PD analysis will be conducted with and without baseline adjustment.
- Secondary Outcome Measures
Name Time Method