Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/08/2007
Date assigned
12/09/2007
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uniklinikum-jena.de/Willkommen.html

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

Publication citations

Additional files

Editorial Notes