Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

NCT01240200 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00046366
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes; elderly; insulin injections

Outcome Measures

Primary Outcomes (2)

• Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score

  Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained from summing responses to questions 1, 4, 5, 6, 7, and 8 and the total score can range from 0 to 36. Higher scores indicate higher satisfaction with diabetes treatment.

  Baseline, Week 12

• Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score

  Treatment satisfaction after crossover into the second treatment period was assessed using the Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc). The questionnaire contains eight items scored on a seven-point scale where -3 = much less satisfied now and 3 = much more satisfied now. The satisfaction score is obtained from summing responses to questions 1, and 4 through 8 (the remaining two items assess perceived blood sugar levels). The total score can range from -18 to 18. Higher scores indicate higher satisfaction with the new diabetes treatment, compared to prior treatment, while scores below 0 mean that satisfaction with the new delivery method of insulin in Period 2 is lower than satisfaction with the delivery method in Period 1.

  Week 24

Secondary Outcomes (4)

• Hemoglobin A1c (HbA1c)

  Baseline, Week 12

• Fasting Blood Glucose

  Baseline, Week 12

• Percent of Participants With Dosing Errors

  Week 24

• Number of Hypoglycemic Events

  Week 24

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Glargine; Device: glargine via insulin pen

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

EXPERIMENTAL

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

Drug: Glargine; Device: glargine via insulin pen

Interventions

Glargine DRUG

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

Also known as: Lantus

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

glargine via insulin pen DEVICE

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

Also known as: Solostar

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Christopher Newton, MD
• Organization: Emory University School of Medicine

cnewton@atlantadiabetes.com

404-355-4393

Study Officials

• Christoper Newton, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

• Dawn Smiley, MD, MSCR

  Emory University SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 15, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 31, 2018
• Results First Posted: October 30, 2014

Record last verified: 2018-10

Locations

US (1)