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Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT01240200
First received: November 9, 2010
Last updated: January 24, 2011
Last verified: November 2010
History of Changes
  Purpose

Several studies have shown that high blood sugar (glucose) levels are associated with diseases caused by the 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 25 week long study, patients 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/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.


Condition Intervention Phase
Diabetes Mellitus
 Drug: Glargine
Device: glargine via insulin pen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy Using Pens for a Basal Insulin Treatment (STEP IT UP a BIT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • treatment satisfaction based on patient survey [ Time Frame: at 0 weeks ] [ Designated as safety issue: No ]
    The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.

  • treatment satisfaction [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.

  • treatment satisfaction [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
    The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.


Secondary Outcome Measures:
  • blood glucose control [ Time Frame: at 0 weeks ] [ Designated as safety issue: No ]

    Secondary outcomes include differences between treatment regimens in any of the following measures:

    Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia


  • blood glucose control [ Time Frame: at 0 weeks ] [ Designated as safety issue: Yes ]

    Secondary outcomes include differences between treatment regimens in any of the following measures:

    1. Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
    2. Accuracy of insulin dosing at weeks 0,12 and 24

  • blood glucose control [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia

  • blood glucose (low blood glucose) [ Time Frame: at 12 weeks ] [ Designated as safety issue: Yes ]

    Secondary outcomes include differences between treatment regimens in any of the following measures:

    1. Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
    2. Accuracy of insulin dosing at weeks 0,12 and 24

  • blood glucose (low blood glucose) [ Time Frame: at 24 weeks ] [ Designated as safety issue: Yes ]

    Secondary outcomes include differences between treatment regimens in any of the following measures:

    1. Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
    2. Accuracy of insulin dosing at weeks 0,12 and 24


Estimated Enrollment: 56
Study Start Date: January 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin glargine via syringe
Insulin glargine via syringe
 Drug: Glargine
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
Other Name: Lantus
Experimental: Insulin glargine via pen
Insulin glargine via pen (Solostar)
 Device: glargine via insulin pen
oral antidiabetic agents plus insulin glargine in a pre-filled pen
Other Name: Solostar

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged ≥65 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240200

Contacts
Contact: Christopher Newton, MD 4047781695 canewto@emory.edu
Contact: Dawn Smiley, MD, MSCR 4047781664 dsmiley@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Sanofi
Investigators
Principal Investigator: Christoper Newton, MD Emory University SOM
Principal Investigator: Dawn Smiley, MD, MSCR Emory University SOM
  More Information

No publications provided

Responsible Party: Christopher Newton, Emory University SOM
ClinicalTrials.gov Identifier: NCT01240200     History of Changes
Other Study ID Numbers: e46366
Study First Received: November 9, 2010
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
diabetes
elderly
insulin injections

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013