World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-005914-18-DE
Date of registration: 02/01/2006
Primary sponsor: Diabetes-Centre Quakenbrueck
Public title: Effect of Insulin Glulisin on postprandial plasma glucose levels in obese subjectts with type 2 diabetes after a standard meal in comparison to Insulin Lispro
Scientific title: Effect of Insulin Glulisin on postprandial plasma glucose levels in obese subjectts with type 2 diabetes after a standard meal in comparison to Insulin Lispro
Date of first enrolment: 15/03/2006
Target sample size: 30
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005914-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria:
Type 2 diabetic subjects
Age: > 30, < 80 years
Insulintherapy > 12 months
BMI: > 28, < 35 kg/m²
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Pregnancy
Nursing
Medication known to influence insulin sensitivity
Alcohol abuse
Drug abuse
Psychiatric illness


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Obese subjects with type 2 diabetes mellitus
Intervention(s)

Trade Name: Apidra
Product Name: Apidra
Pharmaceutical Form: Injection*
INN or Proposed INN: Insulin Glulisin
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 0,05 IU/kg BW-0,5 IU/kg BW

Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Injection*
INN or Proposed INN: Insulin Lispro
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 0,05 IU/kg BW-0,5 IU/kg BW

Primary Outcome(s)
Main Objective: Area under the curve (AUC) plasma glucose 0-1 h
Primary end point(s): Area under the curve (AUC) plasma glucose 0-1 h
Secondary Objective: AUC plasma glucose 0-4 h (end)
Difference plasma glucose at 1 h postprandially
AUC plasma insulin 0-1 h
AUC plasma insulin 0-4 h (end)
Secondary Outcome(s)
Secondary ID(s)
APIDR_L_00465
Source(s) of Monetary Support
Secondary Sponsor(s)
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history