The necessity of an injection-meal-interval in patients with type 2 diabetes mellitus and therapy with human insulin

Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04277490

Enrollment

100

Registered

2007-09-12

Start date

2007-07-01

Completion date

Unknown

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 Nutritional, Metabolic, Endocrine Diabetes

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus 2. Aged 40 - 80 years 3. Therapy with human insulin

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Nutrition disorders 3. Psychological disease 4. Body Mass Index (BMI) less than 25 kg/m^2 5. HbA1c greater than 9%

Design outcomes

Primary

Measure	Time frame
HbA1c, measured from venous blood samples from the finger at baseline and weeks 4, 16 and 28.	—

Secondary

Measure	Time frame
1. Frequency of hypoglycaemia, measured at 4 and 28 weeks 2. Quality of life, measured using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) at weeks 4, 16 and 28 3. Satisfaction of quality of care, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at weeks 4, 16 and 28	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026