N/A
N=102
Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes
Coronary Heart Disease · Stroke · Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT02138006 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Cardiovascular Mortality — 7; 11 participants — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensive insulin treatment (Drug); Standard insulin treatment (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiovascular Mortality |
7; 11 | 0.30 |
| SECONDARY Morbidity of Cardiovascular Complications |
6; 11 | — |
Summary
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02138006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.