Type 2 DiabetesNCT01053234
Different Insulin Regimens and Postprandial Coagulation Activation
A study testing Standardised meals in people with Type 2 Diabetes and Cardiovascular Risk, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Risk, Hemostasis
- What is being tested?
- Standardised meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2007to May 2007
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 30-75 years
- BMI > 25 kg/m2
- type 2 diabetes for more than 4 years
- pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
- metformin with stable dose >1000 mg/d for more than 12 weeks
- acetylsalicylic acid (75 mg/d) for more than 2 weeks
- no other anti-diabetic treatment 3 month previously
- HbA1c<8.5% at recruitment.
Who cannot join
- creatinine > 120 µmol/l
- ALAT /ASAT > 2.5 x upper reference limit
- use of anticoagulants within 1 month previously
- any changes in dose of statins within 1 month previously
- night work
- present or planned pregnancy
Show all 11Show fewer
- mental sickness or alcohol abuse
- clinically relevant major organ or systemic illness
- uncontrolled hypertension >180/110 mmHg
- steroid treatment
- known or suspected allergy to trial medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.
- Being tested
- Standardised meals
- Keywords
- Hyperglycaemia, Postprandial, Type 2 diabetes, Cardiovascular risk markers
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised mealsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Insulin aspart | Experimental | Not described Receives: Dietary Supplement: Standardised meals |
| NPH insulin | Experimental | Not described Receives: Dietary Supplement: Standardised meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prothrombin fragment 1+2
Measured: 7.40; 9.30; 11.30; 13.30; 15.30
Secondary outcomes (1)
C-reactive protein
Measured: 7.40; 9.30; 11.30; 13.30; 15.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Ribe County Hospital, Novo Nordisk A/S
- Investigators
- Jeppe Gram, Ph.D, Principal investigator, Department of Medicine, Hospital of South West Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053234
- Sponsor's protocol ID
- RRS 2006-1032
- Status last verified
- Oct 2022
- First submitted
- 20 Jan 2010
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
- ClinicalTrials.gov ID
- NCT01053234
- Acronym / sponsor ID
- RRS 2006-1032
- Keywords
- Hyperglycaemia, Postprandial, Type 2 diabetes, Cardiovascular risk markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Ribe County Hospital, Novo Nordisk A/S
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 21 Jan 2010 (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 this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin aspart | Experimental | Dietary Supplement: Standardised meals |
| NPH insulin | Experimental | Dietary Supplement: Standardised meals |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 30-75 years
- BMI > 25 kg/m2
- type 2 diabetes for more than 4 years
- pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
- metformin with stable dose >1000 mg/d for more than 12 weeks
Key exclusion criteria (11 listed)
- creatinine > 120 µmol/l
- ALAT /ASAT > 2.5 x upper reference limit
- use of anticoagulants within 1 month previously
- any changes in dose of statins within 1 month previously
- night work
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 |
|---|---|---|
| Standardised meals | Dietary supplement | Insulin aspart, NPH insulin |
Primary outcome
Prothrombin fragment 1+2
Time frame: 7.40; 9.30; 11.30; 13.30; 15.30
1 secondary outcome
C-reactive protein
Time frame: 7.40; 9.30; 11.30; 13.30; 15.30
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 19 Oct 2022.
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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.
Jeppe Gram, Ph.D principal investigator
Department of Medicine, Hospital of South West Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardised meals in people with Type 2 Diabetes and Cardiovascular Risk, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 8 inclusion and 11 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 19 Oct 2022. 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 Denmark. 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?
Prothrombin fragment 1+2 (time frame: 7.40; 9.30; 11.30; 13.30; 15.30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022; AzTrials last refreshed its copy on 29 Oct 2026.