The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin

Diabetes Mellitus Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529165
• Other study ID #: ISRCTN04277490
• Status: Completed
• Phase: N/A
• First received: September 13, 2007
• Last updated: January 12, 2009
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• injection-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: Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes 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.

Locations

Country	Name	City	State
Germany	Friedrich-Schiller-University, department of internal medicine III	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		Week 16 and 28	No
Secondary	Hypoglycemia		Week 16 and 28	No
Secondary	Treatment satisfaction		week 16 and 28	No
Secondary	Quality of Life		week 16 and 28	No