Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

Emory University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Glargine; Device: glargine via insulin pen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01240200

IRB00046366

Details and patient eligibility

About

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 become unable to make enough insulin to control the blood sugars. Pills used to treat diabetes may help for a while, but many times this does not last. When the blood sugar is too high, insulin is frequently recommended and used to treat diabetes. Insulin is often started by adding a long-acting insulin to the medicines a patient already takes. In this study, glargine insulin will be taken together with the diabetes pills currently being used. Glargine is a long-acting insulin which is given under the skin once a day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration).

Currently, insulin delivery is only available as a shot. The purpose of this study is to compare how satisfied patients are when using two different types of insulin shots. Specifically, this study aims to determine if people over 65 years old are more satisfied taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance to use the insulin syringes and the insulin pens.

The ability of patients to give themselves shots can affect how well the sugar is controlled. As people age, medical and other problems may develop that affect their ability to do certain things. Another aim of this study is to determine if the ability to use an insulin pen and insulin syringe is affected by age or some other problem.

During this study, participants will be treated with insulin given by a syringe for 12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction with treatment throughout the study. The investigators hypothesize that among elderly patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal insulin via a pen device results in higher treatment satisfaction scores and more accurate dosing than treatment with basal insulin via conventional vial and syringe methods.

A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for the study is Grady Memorial Hospital clinics in Atlanta, Georgia.

Enrollment: 49 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females aged ≥60 years
2. History of type 2 diabetes of >3 months duration
3. Current use oral antidiabetic agents and/or diet to treat the diabetes
4. A1c ≤10.0% and fasting glucose ≤300 mg/dL
5. A1c ≥7.0% and/or fasting glucose ≥150 mg/dL

Exclusion criteria

1. Subjects with a known allergy to glargine or any of its metabolites
2. Subjects unwilling to self-inject insulin
3. Inability to self-monitor blood glucose
4. Current or previous use of insulin for more than 6 continuous months prior to study enrollment
5. 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
6. Mental condition rendering the subject unable to understand the nature, scope and/or possible consequences of the study
7. Inability or unwillingness to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Vial & Syringe (Period 1) / Pen (Period 2)

Active Comparator group

Description:

Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.

Treatment:

Device: glargine via insulin pen

Drug: Glargine

Pen (Period 1) / Vial & Syringe (Period 2)

Experimental group

Description:

Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.

Treatment:

Device: glargine via insulin pen

Drug: Glargine