Contact information
Type
Scientific
Primary contact
Prof Ulrich Alfons Muller
ORCID ID
Contact details
University Hospital Jena
Department of Internal Medicine III
Bachstr. 18
Jena
07743
Germany
ulrichalfons.mueller@med.uni-jena.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00529165
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
There is no difference in metabolic control in patients with type 2 diabetes mellitus and therapy with human insulin with or without injection-meal-interval.
Ethics approval
Ethics approval received from the Friedrich Schiller University Ethics Committee on the 10th October 2006 (ref: 1855-09/06).
Study design
Monocentric, open, randomised, two-phased, cross-over design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes mellitus type 2
Intervention
The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
1. Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
2. Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Human insulin
Primary outcome measures
HbA1c, measured from venous blood samples from the finger at baseline and weeks 4, 16 and 28.
Secondary outcome measures
1. Frequency of hypoglycaemia, measured at 4 and 28 weeks
2. Quality of life, measured using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) at weeks 4, 16 and 28
3. Satisfaction of quality of care, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at weeks 4, 16 and 28
Overall trial start date
01/07/2007
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 2 diabetes mellitus
2. Aged 40 - 80 years
3. Therapy with human insulin
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Pregnancy
2. Nutrition disorders
3. Psychological disease
4. Body Mass Index (BMI) less than 25 kg/m^2
5. HbA1c greater than 9%
Recruitment start date
01/07/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Jena
Jena
07743
Germany
Sponsor information
Organisation
University Hospital Jena (Germany)
Sponsor details
Department of Internal Medicine III
Bachstr. 18
Jena
07743
Germany
+49 (0)3641 934843
nicolle.mueller@med.uni-jena.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Jena (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary