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Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes (SDIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02138006
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : December 21, 2015
Last Update Posted : October 24, 2016
Information provided by (Responsible Party):
Thomas Nystrom, Karolinska Institutet

Brief Summary:
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Stroke Renal Failure Drug: Intensive insulin treatment Drug: Standard insulin treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stockholm Diabetes Intervention Study
Study Start Date : September 1982
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intensive insulin treatment
Intensive insulin treatment
Drug: Intensive insulin treatment
Mealtime insulin (Actrapid) Basal insulin (Monotard)
Other Name: Basal-bolus insulin treatment

Active Comparator: Standard insulin treatment
Standard insulin treatment
Drug: Standard insulin treatment
Insulin Mixtard
Other Name: Mixed insulin 2-3 times per day

Primary Outcome Measures :
  1. Cardiovascular Mortality [ Time Frame: Up to 28 years ]
    All cause mortality and composite mortality from myocardial infarction, stroke and renal failure

Secondary Outcome Measures :
  1. Morbidity of Cardiovascular Complications [ Time Frame: Up to 28 years ]
    Morbidity of: coronary heart disease, stroke and renal failure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Born 1930 or later
  • Type 1 diabetes
  • Nonproliferative retinopathy
  • Normal serum creatinine
  • Unsatisfactory blood glucose control

Exclusion Criteria:

  • Alcohol/drug abuse
  • Proliferative retinopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02138006

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Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Thomas Nyström, Md, PhD Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm
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Responsible Party: Thomas Nystrom, dr, Karolinska Institutet Identifier: NCT02138006    
Other Study ID Numbers: EPN-2012
First Posted: May 14, 2014    Key Record Dates
Results First Posted: December 21, 2015
Last Update Posted: October 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs