Diabetes Mellitus Type 2
Conditions
Keywords
injection to meal time, human insulin
Brief summary
The purpose of the study is to demonstrate, that 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.
Interventions
PROCEDUREinjection-meal-interval
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.
Sponsors
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * Aged 40 - 80 years * Therapy with human insulin
Exclusion criteria
* Pregnancy * Nutrition disorders * Psychological disease * Body Mass Index (BMI) less than 25 kg/m\^2 * HbA1c greater than 9%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | Week 16 and 28 |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia | Week 16 and 28 |
| Treatment satisfaction | week 16 and 28 |
| Quality of Life | week 16 and 28 |
Countries
Germany
Outcome results
None listed