Diabetes Mellitus Type 2NCT00529165
The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
A study testing injection-meal-interval in people with Diabetes Mellitus Type 2, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- injection-meal-interval
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Aged 40 - 80 years
- Therapy with human insulin
Who cannot join
- Pregnancy
- Nutrition disorders
- Psychological disease
- Body Mass Index (BMI) less than 25 kg/m^2
- HbA1c greater than 9%
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Schiller-University, department of internal medicine III
Jena, 07740
About this study
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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- injection-meal-interval
- Keywords
- injection to meal time, human insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection-meal-intervalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month Receives: Procedure: injection-meal-interval |
| B | Experimental | without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month Receives: Procedure: injection-meal-interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: Week 16 and 28
Secondary outcomes (3)
Hypoglycemia
Measured: Week 16 and 28
Treatment satisfaction
Measured: week 16 and 28
Quality of Life
Measured: week 16 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich A Mueller, Professor, Principal investigator, University of Jena, department of internal medicine III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529165
- Sponsor's protocol ID
- ISRCTN04277490
- Status last verified
- Jan 2009
- First submitted
- 13 Sep 2007
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
PubMed 23340895Muller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x.
PubMed 21219434
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
- ClinicalTrials.gov ID
- NCT00529165
- Acronym / sponsor ID
- ISRCTN04277490
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- injection to meal time, human insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: injection-meal-intervalwith injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month |
| B | Experimental | Procedure: injection-meal-intervalwithout injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Aged 40 - 80 years
- Therapy with human insulin
Key exclusion criteria (5 listed)
- Pregnancy
- Nutrition disorders
- Psychological disease
- Body Mass Index (BMI) less than 25 kg/m^2
- HbA1c greater than 9%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection-meal-intervalThe 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. | Procedure or surgery | A, B |
Primary outcome
HbA1c
Time frame: Week 16 and 28
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
- Derived from this study: PubMed 23340895Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
- Derived from this study: PubMed 21219434Muller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x.
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich A Mueller, Professor principal investigator
University of Jena, department of internal medicine III
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection-meal-interval in people with Diabetes Mellitus Type 2, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Week 16 and 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.