Status:
COMPLETED
Satisfaction of Treatment Among Elderly Patients With Insulin Therapy
Lead Sponsor:
Emory University
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Several studies have shown that high blood sugar (glucose) levels are associated with diseases caused by diabetes. Controlling the glucose may prevent these complications. As people age, their bodies ...
Eligibility Criteria
Inclusion
- Males or females aged ≥60 years
- History of type 2 diabetes of \>3 months duration
- Current use oral antidiabetic agents and/or diet to treat the diabetes
- A1c ≤10.0% and fasting glucose ≤300 mg/dL
- A1c ≥7.0% and/or fasting glucose ≥150 mg/dL
Exclusion
- Subjects with a known allergy to glargine or any of its metabolites
- Subjects unwilling to self-inject insulin
- Inability to self-monitor blood glucose
- Current or previous use of insulin for more than 6 continuous months prior to study enrollment
- Subjects with documented clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, impaired renal function (creatinine \>3.0 mg/dL), uncontrolled endocrine disorders associated with increased insulin resistance such as acromegaly, Cushing's syndrome, or hyperthyroidism
- Mental condition rendering the subject unable to understand the nature, scope and/or possible consequences of the study
- Inability or unwillingness to provide informed consent
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01240200
Start Date
January 1 2011
End Date
December 1 2012
Last Update
October 31 2018
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303