Status:
COMPLETED
Simplified Insulin Protocol Using Lantus in Elderly
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the epi...
Detailed Description
As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with ...
Eligibility Criteria
Inclusion
- Age 70 years or older
- Diagnosis of diabetes mellitus Type II
- At least 2 (short-acting or mixed) insulin injections per day
- At least 1 episode of hypoglycemia (glucose value \<70) on screening CGM
Exclusion
- Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
- Active liver disease (history of cirrhosis or LFT \> 3 times normal)
- On dialysis or with severe renal dysfunction (creatinine clearance \<20 ml/min)
- Malignancy that limits life span to less than 18 months
- Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01480843
Start Date
June 1 2011
End Date
September 1 2015
Last Update
November 8 2017
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215