Type 1 diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog (R)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: U/ml unit(s)/millilitre
Concen
Sponsors
Becton, Dickinson and Company, BD Technologies
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. • 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 ;Primary end point(s): The primary endpoint will be the PK response to changes in rapid-acting insulin infusion rate. | — |
Countries
Germany
Outcome results
None listed