The necessity of an injection-meal-interval in patients with type 2 diabetes mellitus and therapy with human insulin
| ISRCTN | ISRCTN04277490 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04277490 |
| ClinicalTrials.gov number | NCT00529165 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/08/2007
- Registration date
- 12/09/2007
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ulrich Alfons Muller
Scientific
Scientific
University Hospital Jena
Department of Internal Medicine III
Bachstr. 18
Jena
07743
Germany
| ulrichalfons.mueller@med.uni-jena.de |
Study information
| Study design | Monocentric, open, randomised, two-phased, cross-over design. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin |
| Study objectives | 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(s) | Ethics approval received from the Friedrich Schiller University Ethics Committee on the 10th October 2006 (ref: 1855-09/06). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Human insulin |
| Primary outcome measure | 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 study start date | 01/07/2007 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Type 2 diabetes mellitus 2. Aged 40 - 80 years 3. Therapy with human insulin |
| Key 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% |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Hospital Jena
Jena
07743
Germany
07743
Germany
Sponsor information
University Hospital Jena (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Internal Medicine III
Bachstr. 18
Jena
07743
Germany
| Phone | +49 (0)3641 934843 |
|---|---|
| nicolle.mueller@med.uni-jena.de | |
| Website | http://www.uniklinikum-jena.de/Willkommen.html |
"ROR" |
https://ror.org/035rzkx15 |
Funders
Funder type
University/education
University of Jena (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added
