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

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ClinicalTrials.gov Identifier: NCT02138006
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : December 21, 2015
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Nystrom, Karolinska Institutet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Coronary Heart Disease
Stroke
Renal Failure
Interventions Drug: Intensive insulin treatment
Drug: Standard insulin treatment
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Insulin Treatment Standard Insulin Treatment
Hide Arm/Group Description

Intensive insulin treatment

Intensive insulin treatment

Standard insulin treatment

Standard insulin treatment

Period Title: Overall Study
Started 48 54
Completed 48 54
Not Completed 0 0
Arm/Group Title Intensive Insulin Treatment Standard Insulin Treatment Total
Hide Arm/Group Description

Intensive insulin treatment

Intensive insulin treatment

Standard insulin treatment

Standard insulin treatment

Total of all reporting groups
Overall Number of Baseline Participants 48 54 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 54 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
 100.0%
54
 100.0%
102
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 54 participants 102 participants
30  (8) 32  (7) 31  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 54 participants 102 participants
Female
26
  54.2%
28
  51.9%
54
  52.9%
Male
22
  45.8%
26
  48.1%
48
  47.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 48 participants 54 participants 102 participants
48 54 102
1.Primary Outcome
Title Cardiovascular Mortality
Hide Description All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
Time Frame Up to 28 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Insulin Treatment Standard Insulin Treatment
Hide Arm/Group Description:

Intensive insulin treatment

Intensive insulin treatment

Standard insulin treatment

Standard insulin treatment

Overall Number of Participants Analyzed 48 54
Measure Type: Number
Unit of Measure: participants
7 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Insulin Treatment, Standard Insulin Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Morbidity of Cardiovascular Complications
Hide Description Morbidity of: coronary heart disease, stroke and renal failure
Time Frame Up to 28 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Insulin Treatment Standard Insulin Treatment
Hide Arm/Group Description:

Intensive insulin treatment

Intensive insulin treatment

Standard insulin treatment

Standard insulin treatment

Overall Number of Participants Analyzed 48 54
Measure Type: Number
Unit of Measure: participants
6 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Insulin Treatment Standard Insulin Treatment
Hide Arm/Group Description

Intensive insulin treatment

Intensive insulin treatment

Standard insulin treatment

Standard insulin treatment

All-Cause Mortality
Intensive Insulin Treatment Standard Insulin Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Insulin Treatment Standard Insulin Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive Insulin Treatment Standard Insulin Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/54 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Thomas Nyström
Organization: Karolinska Institutet Södersjukhuset
Phone: +46704325214
Responsible Party: Thomas Nystrom, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02138006     History of Changes
Other Study ID Numbers: EPN-2012
First Submitted: May 9, 2014
First Posted: May 14, 2014
Results First Submitted: November 16, 2015
Results First Posted: December 21, 2015
Last Update Posted: October 24, 2016