Diabetes
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog
Product Code: EU/1/96/007/004
Pharmaceutical Form: Injection*
Trade Name: Huminsulin Profil I
Sponsors
Profil Institut fuer Stoffwechselforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - type 2 diabetes - age 70 years or above - HbA1c 6-12% (inclusive) - insulin therapy with twice daily injections of a premixed insulin for at least 3 months - able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - significant cardiovascular event (e.g. myocardial infarction, stroke) in the past 6 months - presence of a disease which might influence the study results or involves an additional risk for study participation for the subjects - clinically relevant deviations in lab parameters from normal (e.g. liver enzymes more than threefold above upper limit of normal, serum creatinine higher than 1.7 mg/dl - concomitant medication which might influence the study results (e.g. steroids) - alcohol or drug addiction - inability to understand the informed consent or the study procedures - participation in another trial in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether or not a supplemental postprandial therapy with insulin lispro in comparion with a conventional insulin therapy with twice daily administrations of a premixed human insulin formulation reduces the number of in-patient treatment days in geriatric patients with diabetes ; Secondary Objective: To investigate whether or not a supplemental postprandial therapy with insulin lispro in comparion with a conventional insulin therapy with twice daily administrations of a premixed human insulin formulation has an impact on - the incidence of hospital admissions - the incidence of hyperglycaemic or hypoglycaemic episodes - the incidence of severe hypoglycaemia - the incidence of hyperosmolar coma - mortality (total mortality and diabetes-related mortality) - diabetes control (HbA1c) - treatment satisfaction (QoL questionnaire) in geriatric patients with diabetes ;Primary end point(s): Number of in-patient days during study duration | — |
Countries
Germany
Outcome results
None listed