---
title: The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
nct_id: NCT00529165
overall_status: COMPLETED
phase: NA
sponsor: University of Jena
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus Type 2
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00529165.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00529165"
ct_last_update_post_date: 2009-01-14
last_seen_at: "2026-05-12T06:31:40.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin

**NCT ID:** [NCT00529165](https://clinicaltrials.gov/study/NCT00529165)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** University of Jena
- **Conditions:** Diabetes Mellitus Type 2
- **Start Date:** 2007-07
- **Completion Date:** 2009-01
- **CT.gov Last Update:** 2009-01-14

## Brief 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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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%
```

## Arms

- **A** (EXPERIMENTAL) — with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month
- **B** (EXPERIMENTAL) — without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month

## Interventions

- **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:

1. Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
2. 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

- **HbA1c** _(time frame: Week 16 and 28)_

## Secondary Outcomes

- **Hypoglycemia** _(time frame: Week 16 and 28)_
- **Treatment satisfaction** _(time frame: week 16 and 28)_
- **Quality of Life** _(time frame: week 16 and 28)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.friedrich-schiller-university, department of internal medicine iii|jena||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00529165.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00529165*  
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