Diabetes mellitus Type I MedDRA version: 12.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Huminsulin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Conce
Sponsors
Becton, Dickinson and Company, BD Technologies
Eligibility
Sex/Gender
All
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 patient) •Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year. •Usage of insulin pump therapy or multiple daily injections (“basal-bolus”) with carb counting for at least six months •Age in the range of =18 and =55 years •Body mass index (BMI) =32 kg/m² •HbA1c = 8.0% at screening •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 to 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 1.3, PTT >50 sec. •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 such medical treatment has existed for at least three months and is not changing, prior to 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. •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To compare between the ID and SC routes the relative PD times “in-range” (70-180 mg/dL) for glycemic excursions following two types of standardized meals and three dose ranges (optimum dose and +/- 30%) given immediately before the meal (2 min prior to consumption).;Secondary Objective: •To compare the pharmacokinetics of insulin absorption as well as the intra-subject variability for each delivery routes. •To determine the PPG effect of earlier pre-meal dose timing for the ID route, using the “optimal” insulin dose determined from the dose-ranging portion of the study. •To evaluate biomechanical feasibility of commercial insulin infusion pump to deliver ID over a multi-hour basal and bolus infusion period. ;Primary end point(s): •Post-prandial time “in-range” glucose levels (70-180 mg/dL) as measured by collecting venous blood samples and determining glucose levels immediately by means of a laboratory method •Total time “in range” will be measured after each meal. •Total time of BG between 60-70 mg/dL, 180mg/dL and > 220 mg/dL will also be assessed. •Confirmatory blood glucose values will be measured additionally | — |
Countries
Germany
Outcome results
None listed