Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

NCT ID: NCT01240200

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Glargine

Intervention Type: DRUG

oral antidiabetic agents plus once daily insulin glargine via an insulin syringe

glargine via insulin pen

Intervention Type: DEVICE

oral antidiabetic agents plus insulin glargine in a pre-filled pen

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

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

Group Type: EXPERIMENTAL

Glargine

Intervention Type: DRUG

oral antidiabetic agents plus once daily insulin glargine via an insulin syringe

glargine via insulin pen

Intervention Type: DEVICE

oral antidiabetic agents plus insulin glargine in a pre-filled pen

Interventions

Glargine

oral antidiabetic agents plus once daily insulin glargine via an insulin syringe

Intervention Type: DRUG

glargine via insulin pen

oral antidiabetic agents plus insulin glargine in a pre-filled pen

Intervention Type: DEVICE

Other Intervention Names

Lantus; Solostar

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoper Newton, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University SOM

Dawn Smiley, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Emory University SOM

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00046366

Identifier Type: -

Identifier Source: org_study_id