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Completed

NCT Number: NCT00529165

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Schiller-University, department of internal medicine III

Jena, 07740, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

injection-meal-interval

Procedure

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.

Primary outcomes

  1. HbA1c

    Time frame: Week 16 and 28

Secondary outcomes

  1. Hypoglycemia

    Time frame: Week 16 and 28

  2. Treatment satisfaction

    Time frame: week 16 and 28

  3. Quality of Life

    Time frame: week 16 and 28

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Sep 14, 2007
Registry last updated
Jan 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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