Diabetes mellitus
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog (R)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Lispro
Concentration unit: IU/ml international unit(s)/millilitre
Concentration t
Sponsors
Roche Diagnostics GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
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 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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).;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. | — |
Countries
Germany
Outcome results
None listed