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

University of Jena

Status: Completed

Conditions: Diabetes Mellitus Type 2

Treatments: Procedure: injection-meal-interval

Study type: Interventional

Funder types: Other

Identifiers

NCT00529165

ISRCTN04277490

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Procedure: injection-meal-interval

B

Experimental group

Description:

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

Treatment:

Procedure: injection-meal-interval