Type 2 Diabetes MellitusPhase 4NCT00747409
Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes
A Phase 4 study testing insulin aspart and detemir (NovoRapid, Levemir) and human regular insulin and NPH insulin (Actrapid, Protaphne) in people with Type 2 Diabetes Mellitus, run by Munich Municipal Hospital at 1 site in Germany.
Trial summary
Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- insulin aspart and detemir (NovoRapid, Levemir) and human regular insulin and NPH insulin (Actrapid, Protaphne)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Jun 2009
- Phase
- Phase 4
- 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, insulin therapy
Who cannot join
- type 1 diabetes, BMI >40, pregnancy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes.
Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.
Read the detailed description
This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history.
In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose <110 mg/dL and post prandial blood glucose <150 mg/dL).
All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- insulin aspart and detemir (NovoRapid, Levemir), human regular insulin and NPH insulin (Actrapid, Protaphne)
- Keywords
- postprandial glucose, diastolic function, analogue insulins
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspart and detemir (NovoRapid, Levemir)Drug
Also called Insulin NovoRapid, Insulin Levemir
use of basal-bolus therapy with insulin aspart and detemir
human regular insulin and NPH insulin (Actrapid, Protaphne)Drug
Also called Insulin Actrapid, Insulin Protaphne
basal-bolus therapy with human regular and NPH insulin
| Study group | Role | What they receive |
|---|---|---|
| Hum | Active comparator | use of human regular insulin and NPH insulin Receives: Drug: human regular insulin and NPH insulin (Actrapid, Protaphne) |
| Ana | Active comparator | use of insulin aspart and insulin detemir Receives: Drug: insulin aspart and detemir (NovoRapid, Levemir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial blood glucose at the end of the study and its change from baseline.
Measured: 24-48 months treatment period
Secondary outcomes (1)
diastolic myocardial function
Measured: 24-48 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startJul 2004
- Primary completionMar 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munich Municipal Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Investigators
- Petra-Maria Schumm-Draeger, MD, PHD, Principal investigator, Munich Academic Teaching Hospital BogenhausenHelene von Bibra, MD, PHD, Study chair, Munich Academic Teaching Hospital Bogenhausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747409
- Sponsor's protocol ID
- AnaHum
- Status last verified
- Sep 2008
- First submitted
- 4 Sep 2008
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bretzel RG, Arnolds S, Medding J, Linn T. A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care. 2004 May;27(5):1023-7. doi: 10.2337/diacare.27.5.1023.
PubMed 15111514von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Ryden L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. doi: 10.1136/hrt.2003.020842. No abstract available.
PubMed 15547039Shaw JE, Hodge AM, de Courten M, Chitson P, Zimmet PZ. Isolated post-challenge hyperglycaemia confirmed as a risk factor for mortality. Diabetologia. 1999 Sep;42(9):1050-4. doi: 10.1007/s001250051269.
PubMed 10447514von Bibra H, Siegmund T, Kingreen I, Riemer M, Schuster T, Schumm-Draeger PM. Effects of analogue insulin in multiple daily injection therapy of type 2 diabetes on postprandial glucose control and cardiac function compared to human insulin: a randomized controlled long-term study. Cardiovasc Diabetol. 2016 Jan 16;15:7. doi: 10.1186/s12933-015-0320-2.
PubMed 26772807
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00747409
- Acronym / sponsor ID
- AnaHum
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- postprandial glucose, diastolic function, analogue insulins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Munich Municipal HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jul 2004
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 5 Sep 2008 (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.
Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.
Detailed description
This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history.
In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose <110 mg/dL and post prandial blood glucose <150 mg/dL).
All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hum | Active comparator | Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)use of human regular insulin and NPH insulin |
| Ana | Active comparator | Drug: insulin aspart and detemir (NovoRapid, Levemir)use of insulin aspart and insulin detemir |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes, insulin therapy
Key exclusion criteria (1 listed)
- type 1 diabetes, BMI >40, pregnancy,
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 |
|---|---|---|
| insulin aspart and detemir (NovoRapid, Levemir)Also: Insulin NovoRapid, Insulin Levemiruse of basal-bolus therapy with insulin aspart and detemir | Drug | Ana |
| human regular insulin and NPH insulin (Actrapid, Protaphne)Also: Insulin Actrapid, Insulin Protaphnebasal-bolus therapy with human regular and NPH insulin | Drug | Hum |
Primary outcome
postprandial blood glucose at the end of the study and its change from baseline.
Time frame: 24-48 months treatment period
1 secondary outcome
diastolic myocardial function
Time frame: 24-48 months treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
- Background: PubMed 15111514Bretzel RG, Arnolds S, Medding J, Linn T. A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care. 2004 May;27(5):1023-7. doi: 10.2337/diacare.27.5.1023.
- Background: PubMed 15547039von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Ryden L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. doi: 10.1136/hrt.2003.020842. No abstract available.
- Background: PubMed 10447514Shaw JE, Hodge AM, de Courten M, Chitson P, Zimmet PZ. Isolated post-challenge hyperglycaemia confirmed as a risk factor for mortality. Diabetologia. 1999 Sep;42(9):1050-4. doi: 10.1007/s001250051269.
- Derived from this study: PubMed 26772807von Bibra H, Siegmund T, Kingreen I, Riemer M, Schuster T, Schumm-Draeger PM. Effects of analogue insulin in multiple daily injection therapy of type 2 diabetes on postprandial glucose control and cardiac function compared to human insulin: a randomized controlled long-term study. Cardiovasc Diabetol. 2016 Jan 16;15:7. doi: 10.1186/s12933-015-0320-2.
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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.
Petra-Maria Schumm-Draeger, MD, PHD principal investigator
Munich Academic Teaching Hospital Bogenhausen
Helene von Bibra, MD, PHD study chair
Munich Academic Teaching Hospital Bogenhausen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin aspart and detemir (NovoRapid, Levemir) and human regular insulin and NPH insulin (Actrapid, Protaphne) in people with Type 2 Diabetes Mellitus, run by Munich Municipal Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
postprandial blood glucose at the end of the study and its change from baseline. (time frame: 24-48 months treatment period). 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 NCT00747409, which also lists 4 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 5 Sep 2008.