NCT02138006

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1982

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1982

Completed
29.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 21, 2015

Completed
Last Updated

October 24, 2016

Status Verified

August 1, 2016

Enrollment Period

29.3 years

First QC Date

May 9, 2014

Results QC Date

November 16, 2015

Last Update Submit

August 31, 2016

Conditions

Coronary Heart DiseaseStrokeRenal Failure

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Mortality

    All cause mortality and composite mortality from myocardial infarction, stroke and renal failure

    Up to 28 years

Secondary Outcomes (1)

  • Morbidity of Cardiovascular Complications

    Up to 28 years

Study Arms (2)

Intensive insulin treatment

EXPERIMENTAL

Intensive insulin treatment

Drug: Intensive insulin treatment

Standard insulin treatment

ACTIVE COMPARATOR

Standard insulin treatment

Drug: Standard insulin treatment

Interventions

Intensive insulin treatmentDRUG

Mealtime insulin (Actrapid) Basal insulin (Monotard)

Also known as: Basal-bolus insulin treatment
Intensive insulin treatment
Standard insulin treatmentDRUG

Insulin Mixtard

Also known as: Mixed insulin 2-3 times per day
Standard insulin treatment

Eligibility Criteria

Age18 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Alcohol/drug abuse
  • Proliferative retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 8147960BACKGROUND

  • Jensen-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.

    PMID: 8772731BACKGROUND

  • Reichard 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.

    PMID: 3048052BACKGROUND

  • Reichard 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.

    PMID: 8288056BACKGROUND

  • Rathsman 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.

    PMID: 24802206BACKGROUND

MeSH Terms

Conditions

Coronary DiseaseStrokeRenal Insufficiency

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Thomas Nyström
Organization
Karolinska Institutet Södersjukhuset
thomas.nystrom@sodersjukhuset.se
+46704325214

Study Officials

  • Thomas Nyström, Md, PhD

    Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 14, 2014

Study Start

September 1, 1982

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 24, 2016

Results First Posted

December 21, 2015

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

SE(1)