Clinical trial NCT01480843: Simplified Insulin Protocol Using Lantus in Elderly
Official title: Simplification of Diabetes Regimen in Elderly Patients Using Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: simplification
glargine
elderly
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2011-11-29
Enrollment: 65
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 episodes of low blood glucose.

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 complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Duration of Hypoglycemia Episodes
timeFrame: baseline, 5 months, 8 months
measure: Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months
timeFrame: baseline, 5 months, 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Medha N Munshi, MD
role: PRINCIPAL_INVESTIGATOR
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