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

Sponsored by:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00529165

Purpose

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.

Condition	Intervention
Diabetes Mellitus Type 2	Procedure: injection-meal-interval

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study

Further study details as provided by University of Jena:

Primary Outcome Measures:

HbA1c [ Time Frame: Week 16 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hypoglycemia [ Time Frame: Week 16 and 28 ] [ Designated as safety issue: No ]
Treatment satisfaction [ Time Frame: week 16 and 28 ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: week 16 and 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Study Completion Date:	January 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month	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.
B: Experimental without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month	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.

Arms

Assigned Interventions

A: Experimental

with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month

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.

B: Experimental

without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529165

Locations

Germany
Friedrich-Schiller-University, department of internal medicine III
Jena, Germany, 07740

Sponsors and Collaborators

University of Jena

Investigators

Principal Investigator:

Ulrich A Mueller, Professor

University of Jena, department of internal medicine III

More Information

Responsible Party:	University Hospital Jena ( Prof. Dr. med. Ulrich Alfons Müller )
Study ID Numbers:	ISRCTN04277490
Study First Received:	September 13, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00529165
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Jena:

injection to meal time
human insulin

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009