Trial Outcomes & Findings for Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes (NCT NCT02138006)

NCT ID: NCT02138006

Last Updated: 2016-10-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: Up to 28 years
• Results posted on: 2016-10-24

Participant Flow

Participant milestones

Measure	Intensive Insulin Treatment Intensive insulin treatment Intensive insulin treatment	Standard Insulin Treatment Standard insulin treatment Standard insulin treatment
Overall Study STARTED	48	54
Overall Study COMPLETED	48	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intensive Insulin Treatment n=48 Participants Intensive insulin treatment Intensive insulin treatment	Standard Insulin Treatment n=54 Participants Standard insulin treatment Standard insulin treatment	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	54 Participants n=7 Participants	102 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30 years STANDARD_DEVIATION 8 • n=5 Participants	32 years STANDARD_DEVIATION 7 • n=7 Participants	31 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Sweden	48 participants n=5 Participants	54 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 years

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

Outcome measures

Measure	Intensive Insulin Treatment n=48 Participants Intensive insulin treatment Intensive insulin treatment	Standard Insulin Treatment n=54 Participants Standard insulin treatment Standard insulin treatment
Cardiovascular Mortality	7 participants	11 participants

SECONDARY outcome

Timeframe: Up to 28 years

Morbidity of: coronary heart disease, stroke and renal failure

Outcome measures

Measure	Intensive Insulin Treatment n=48 Participants Intensive insulin treatment Intensive insulin treatment	Standard Insulin Treatment n=54 Participants Standard insulin treatment Standard insulin treatment
Morbidity of Cardiovascular Complications	6 participants	11 participants

Adverse Events

Intensive Insulin Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Insulin Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Nyström

Karolinska Institutet Södersjukhuset

Phone: +46704325214

Email: thomas.nystrom@sodersjukhuset.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place