Coronary Heart DiseaseSDISNCT02138006
Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes
A study testing Intensive insulin treatment and Standard insulin treatment in people with Coronary Heart Disease and Stroke, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment Read more about this study
- Who is it for?
- Ages 18 to 52 years
- Conditions the study is for
- Coronary Heart Disease, Stroke, Renal Failure
- What is being tested?
- Intensive insulin treatment and Standard insulin treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- Sep 1982to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 52 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Born 1930 or later
- Type 1 diabetes
- Nonproliferative retinopathy
- Normal serum creatinine
- Unsatisfactory blood glucose control
Who cannot join
- Alcohol/drug abuse
- Proliferative retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stockholm Diabetes Intervention Study
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
Read the detailed description
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.
In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.
- Conditions
- Coronary Heart Disease, Stroke, Renal Failure
- Being tested
- Intensive insulin treatment, Standard insulin treatment
- Medical subject headings
- Coronary Disease, Stroke, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive insulin treatmentDrug
Also called Basal-bolus insulin treatment
Mealtime insulin (Actrapid) Basal insulin (Monotard)
Standard insulin treatmentDrug
Also called Mixed insulin 2-3 times per day
Insulin Mixtard
| Study group | Role | What they receive |
|---|---|---|
| Intensive insulin treatment | Experimental | Intensive insulin treatment Receives: Drug: Intensive insulin treatment |
| Standard insulin treatment | Active comparator | Standard insulin treatment Receives: Drug: Standard insulin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Mortality
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
Measured: Up to 28 years
Secondary outcomes (1)
Morbidity of Cardiovascular Complications
Morbidity of: coronary heart disease, stroke and renal failure
Measured: Up to 28 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startSep 1982
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Nystrom, Karolinska Institutet
- Investigators
- Thomas Nyström, Md, PhD, Principal investigator, Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138006
- Sponsor's protocol ID
- EPN-2012
- Acronym
- SDIS
- Status last verified
- Aug 2016
- First submitted
- 9 May 2014
- Last updated
- 24 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med. 1993 Jul 29;329(5):304-9. doi: 10.1056/NEJM199307293290502.
PubMed 8147960Jensen-Urstad KJ, Reichard PG, Rosfors JS, Lindblad LE, Jensen-Urstad MT. Early atherosclerosis is retarded by improved long-term blood glucose control in patients with IDDM. Diabetes. 1996 Sep;45(9):1253-8. doi: 10.2337/diab.45.9.1253.
PubMed 8772731Reichard P, Britz A, Cars I, Nilsson BY, Sobocinsky-Olsson B, Rosenqvist U. The Stockholm Diabetes Intervention Study (SDIS): 18 months' results. Acta Med Scand. 1988;224(2):115-22. doi: 10.1111/j.0954-6820.1988.tb16748.x.
PubMed 3048052Reichard P, Pihl M. Mortality and treatment side-effects during long-term intensified conventional insulin treatment in the Stockholm Diabetes Intervention Study. Diabetes. 1994 Feb;43(2):313-7. doi: 10.2337/diab.43.2.313.
PubMed 8288056Rathsman B, Jensen-Urstad K, Nystrom T. Intensified insulin treatment is associated with improvement in skin microcirculation and ischaemic foot ulcer in patients with type 1 diabetes mellitus: a long-term follow-up study. Diabetologia. 2014 Aug;57(8):1703-10. doi: 10.1007/s00125-014-3248-2. Epub 2014 May 7.
PubMed 24802206
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stockholm Diabetes Intervention Study
- ClinicalTrials.gov ID
- NCT02138006
- Acronym / sponsor ID
- SDIS / EPN-2012
- Conditions
- Coronary Heart Disease, Stroke, Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 1982
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 21 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
Detailed description
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.
In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive insulin treatment | Experimental | Drug: Intensive insulin treatmentIntensive insulin treatment |
| Standard insulin treatment | Active comparator | Drug: Standard insulin treatmentStandard insulin treatment |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Born 1930 or later
- Type 1 diabetes
- Nonproliferative retinopathy
- Normal serum creatinine
- Unsatisfactory blood glucose control
Key exclusion criteria (2 listed)
- Alcohol/drug abuse
- Proliferative retinopathy
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 |
|---|---|---|
| Intensive insulin treatmentAlso: Basal-bolus insulin treatmentMealtime insulin (Actrapid) Basal insulin (Monotard) | Drug | Intensive insulin treatment |
| Standard insulin treatmentAlso: Mixed insulin 2-3 times per dayInsulin Mixtard | Drug | Standard insulin treatment |
Primary outcome
Cardiovascular Mortality
Time frame: Up to 28 years
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
1 secondary outcome
Morbidity of Cardiovascular Complications
Time frame: Up to 28 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8147960Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med. 1993 Jul 29;329(5):304-9. doi: 10.1056/NEJM199307293290502.
- Background: PubMed 8772731Jensen-Urstad KJ, Reichard PG, Rosfors JS, Lindblad LE, Jensen-Urstad MT. Early atherosclerosis is retarded by improved long-term blood glucose control in patients with IDDM. Diabetes. 1996 Sep;45(9):1253-8. doi: 10.2337/diab.45.9.1253.
- Background: PubMed 3048052Reichard P, Britz A, Cars I, Nilsson BY, Sobocinsky-Olsson B, Rosenqvist U. The Stockholm Diabetes Intervention Study (SDIS): 18 months' results. Acta Med Scand. 1988;224(2):115-22. doi: 10.1111/j.0954-6820.1988.tb16748.x.
- Background: PubMed 8288056Reichard P, Pihl M. Mortality and treatment side-effects during long-term intensified conventional insulin treatment in the Stockholm Diabetes Intervention Study. Diabetes. 1994 Feb;43(2):313-7. doi: 10.2337/diab.43.2.313.
- Background: PubMed 24802206Rathsman B, Jensen-Urstad K, Nystrom T. Intensified insulin treatment is associated with improvement in skin microcirculation and ischaemic foot ulcer in patients with type 1 diabetes mellitus: a long-term follow-up study. Diabetologia. 2014 Aug;57(8):1703-10. doi: 10.1007/s00125-014-3248-2. Epub 2014 May 7.
- Individual participant dataSharing planned: Yes
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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.
Thomas Nyström, Md, PhD principal investigator
Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive insulin treatment and Standard insulin treatment in people with Coronary Heart Disease and Stroke, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 2 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 24 Oct 2016. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiovascular Mortality (time frame: Up to 28 years). 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 NCT02138006, which also lists 5 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 24 Oct 2016.