The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Jul 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 13, 2007
CompletedFirst Posted
Study publicly available on registry
September 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJanuary 14, 2009
January 1, 2009
1 year
September 13, 2007
January 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
Week 16 and 28
Secondary Outcomes (3)
Hypoglycemia
Week 16 and 28
Treatment satisfaction
week 16 and 28
Quality of Life
week 16 and 28
Study Arms (2)
A
EXPERIMENTALwith injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month
B
EXPERIMENTALwithout injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month
Interventions
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.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Aged 40 - 80 years
- Therapy with human insulin
You may not qualify if:
- Pregnancy
- Nutrition disorders
- Psychological disease
- Body Mass Index (BMI) less than 25 kg/m\^2
- HbA1c greater than 9%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friedrich-Schiller-University, department of internal medicine III
Jena, 07740, Germany
Related Publications (2)
Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
PMID: 23340895DERIVEDMuller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x.
PMID: 21219434DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich A Mueller, Professor
University of Jena, department of internal medicine III
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2007
First Posted
September 14, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2008
Study Completion
January 1, 2009
Last Updated
January 14, 2009
Record last verified: 2009-01