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

Stockholm Diabetes Intervention Study


Lead Sponsor: Karolinska Institutet

Source 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

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.

Overall Status Completed
Start Date September 1982
Completion Date December 2011
Primary Completion Date December 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cardiovascular Mortality Up to 28 years
Secondary Outcome
Measure Time Frame
Morbidity of Cardiovascular Complications Up to 28 years
Enrollment 102

Intervention Type: Drug

Intervention Name: Intensive insulin treatment

Description: Mealtime insulin (Actrapid) Basal insulin (Monotard)

Arm Group Label: Intensive insulin treatment

Other Name: Basal-bolus insulin treatment

Intervention Type: Drug

Intervention Name: Standard insulin treatment

Description: Insulin Mixtard

Arm Group Label: Standard insulin treatment

Other Name: Mixed insulin 2-3 times per day



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

Gender: All

Minimum Age: 18 Years

Maximum Age: 52 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Thomas Nyström, Md, PhD Principal Investigator Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm
Facility: Södersjukhuset
Location Countries


Verification Date

August 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Karolinska Institutet

Investigator Full Name: Thomas Nystrom

Investigator Title: dr

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intensive insulin treatment

Type: Experimental

Description: Intensive insulin treatment

Label: Standard insulin treatment

Type: Active Comparator

Description: Standard insulin treatment

Acronym SDIS
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov