Type 2 Diabetes MellitusPhase 4SDDSNCT00121966
South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
A Phase 4 study testing Insulin Aspart, Insulin NPH and Metformin in people with Type 2 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The primary objective of this study is: To investigate whether insulin aspart with meals is better than a standard treatment with insulin NPH at bedtime, evaluated by HbA1c. The secondary objectives of this study are: To study if a combination treatment with metformin and/or rosiglitazone and insulin aspart with meals… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Aspart, Insulin NPH and Metformin
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2003to Jul 2007
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 30 and 70 years
- Fasting C-peptide >300 pmol/l
- Body mass index (BMI) > 25 kg/m2
- Diabetes for more than 2 years
- Pharmacological antidiabetic treatment for more than 3 months
- 7.0%<HbA1c<12.0% at randomisation
- Patient willing to sign informed consent
- Fertile women: negative pregnancy test and use of oral or intra-uterine contraception or depot gestagen.
Who cannot join
- S-creatinine > 120 μmol/l
- History of intolerance to metformin or glitazones
- S-ALAT/S-ASAT > 2.5 x upper normal limit
- Total cholesterol > 10 mmol/l
- Total triglyceride > 8 mmol/l
- Hemoglobin (Hb) < normal range
Show all 18Show fewer
- Treatment with glitazone preceding 30 days New York Heart Association (NYHA) functional class III or IV
- Night work
- Present or planned pregnancy
- Poor vision impeding insulin administration
- Unawareness of hypoglycaemia (complete or partly)
- Mental illness or alcohol abuse
- Clinically relevant major organ or systemic illness
- Uncontrolled hypertension >180/110 mmHg, systolic or diastolic
- Steroid treatment
- Severe lung disease
- A history of malign disease
- An expectation that the patient will not be collaborative or will not be able to understand the character of this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: South Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological Antidiabetic Treatment of Type 2 Diabetes Mellitus
The primary objective of this study is:
- To investigate whether insulin aspart with meals is better than a standard treatment with insulin NPH at bedtime, evaluated by HbA1c.
Read more
The secondary objectives of this study are:
- To study if a combination treatment with metformin and/or rosiglitazone and insulin aspart with meals is better than a standard treatment with insulin NPH combined with one or more of the above oral antidiabetic drugs. According to the hypothesis, special focus will be given to the treatment group with insulin aspart combined with metformin and rosiglitazone. The treatment effect will be evaluated by HbA1c.
- To examine the effects of the treatments on glucose metabolism and beta cell function, evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and lactate.
- To examine the effects of the treatments on cardiovascular risk factors evaluated by serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and electrocardiogram (ECG).
- To quantify and describe the patients' subjective experiences of the two different insulin treatments (quality of life assessment)
- To examine patients with type 2 diabetes for the presence of variability in a series of genes, which are known to or are assumed to:
- affect the long term outcome;
- determine the responsiveness to treatment with diet, exercise and drugs targeting the known risk markers for late diabetic complications; and
- after intervention, to analyse the complex interrelationships between genotypes and clinical endpoints and the responsiveness to actual treatment modalities.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Aspart, Insulin NPH, Metformin, Rosiglitazone
- Keywords
- Type 2 diabetes, Insulin Aspart, Insulin NPH, Metformin, Rosiglitazone
- 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 AspartDrug
Insulin NPHDrug
MetforminDrug
RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c following two years of treatment
Secondary outcomes (10)
body weight
blood pressure
fasting blood glucose
diurnal blood glucose profiles (self monitored and continuously monitored)
fasting cholesterol (including HDL, LDL, and triglyceride)
free fatty acids
lactate
fasting insulin, proinsulin-C-peptide
urine glucose
urine albumin/creatinine ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJan 2003
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jeppe Gram, MD, PhD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121966
- Sponsor's protocol ID
- 001
- Acronym
- SDDS
- Status last verified
- Jun 2008
- First submitted
- 8 Jul 2005
- Last updated
- 19 Jun 2008
- Results posted
- No
Publications
Skov V, Cangemi C, Gram J, Christensen MM, Grodum E, Sorensen D, Argraves WS, Henriksen JE, Rasmussen LM. Metformin, but not rosiglitazone, attenuates the increasing plasma levels of a new cardiovascular marker, fibulin-1, in patients with type 2 diabetes. Diabetes Care. 2014;37(3):760-6. doi: 10.2337/dc13-1022. Epub 2013 Oct 17.
PubMed 24135389
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological Antidiabetic Treatment of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00121966
- Acronym / sponsor ID
- SDDS / 001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, Insulin Aspart, Insulin NPH, Metformin, Rosiglitazone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Jul 2005 (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 primary objective of this study is:
- To investigate whether insulin aspart with meals is better than a standard treatment with insulin NPH at bedtime, evaluated by HbA1c.
The secondary objectives of this study are:
- To study if a combination treatment with metformin and/or rosiglitazone and insulin aspart with meals is better than a standard treatment with insulin NPH combined with one or more of the above oral antidiabetic drugs. According to the hypothesis, special focus will be given to the treatment group with insulin aspart combined with metformin and rosiglitazone. The treatment effect will be evaluated by HbA1c.
- To examine the effects of the treatments on glucose metabolism and beta cell function, evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and lactate.
- To examine the effects of the treatments on cardiovascular risk factors evaluated by serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and electrocardiogram (ECG).
- To quantify and describe the patients' subjective experiences of the two different insulin treatments (quality of life assessment)
- To examine patients with type 2 diabetes for the presence of variability in a series of genes, which are known to or are assumed to:
- affect the long term outcome;
- determine the responsiveness to treatment with diet, exercise and drugs targeting the known risk markers for late diabetic complications; and
- after intervention, to analyse the complex interrelationships between genotypes and clinical endpoints and the responsiveness to actual treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages between 30 and 70 years
- Fasting C-peptide >300 pmol/l
- Body mass index (BMI) > 25 kg/m2
- Diabetes for more than 2 years
- Pharmacological antidiabetic treatment for more than 3 months
Key exclusion criteria (18 listed)
- S-creatinine > 120 μmol/l
- History of intolerance to metformin or glitazones
- S-ALAT/S-ASAT > 2.5 x upper normal limit
- Total cholesterol > 10 mmol/l
- Total triglyceride > 8 mmol/l
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 | Drug | – |
| Insulin NPH | Drug | – |
| Metformin | Drug | – |
| Rosiglitazone | Drug | – |
Primary outcome
HbA1c following two years of treatment
10 secondary outcomes
body weight
blood pressure
fasting blood glucose
diurnal blood glucose profiles (self monitored and continuously monitored)
fasting cholesterol (including HDL, LDL, and triglyceride)
free fatty acids
lactate
fasting insulin, proinsulin-C-peptide
urine glucose
urine albumin/creatinine ratio
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 Jun 2008.
- Derived from this study: PubMed 24135389Skov V, Cangemi C, Gram J, Christensen MM, Grodum E, Sorensen D, Argraves WS, Henriksen JE, Rasmussen LM. Metformin, but not rosiglitazone, attenuates the increasing plasma levels of a new cardiovascular marker, fibulin-1, in patients with type 2 diabetes. Diabetes Care. 2014;37(3):760-6. doi: 10.2337/dc13-1022. Epub 2013 Oct 17.
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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, MD, PhD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
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, Insulin NPH and Metformin in people with Type 2 Diabetes Mellitus, run by Odense University Hospital 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 18 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 Jun 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 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.
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?
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 following two years of treatment. 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 NCT00121966, which also lists 1 linked publication.
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 Jun 2008.