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NCT01240200 · ClinicalTrials.gov registry record · Phase 4

Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

A Phase 4 study, sponsored by Emory University.

Completed
Registry status
Phase 4
Development phase
49
Enrollment target

NCT01240200: Completed Phase 4 study, sponsored by Emory University.

NCT01240200 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01240200, a Phase 4 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 4
Development phase
49 participants
Enrollment target

Study 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

Primary Outcome

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.

Interventions

  • DRUG Glargine
  • DEVICE glargine via insulin pen

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2011-01
Est. Completion 2012-12
Phase Phase 4
Emory University

1,208 total trials

What the finished NCT01240200 record still lists

NCT01240200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Glargine is the first listed.

NCT01240200 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01240200 about?

NCT01240200 is a clinical study titled "Satisfaction of Treatment Among Elderly Patients With Insulin Therapy". 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 h...

What is the current status of trial NCT01240200?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2011-01. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01240200?

The interventions under investigation include: Glargine (DRUG), glargine via insulin pen (DEVICE).

Who is sponsoring clinical trial NCT01240200?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01240200's enrollment target sits among peer trials

49 1323rd of 2000 higher than 670 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01240200, the US trial registry maintained by the National Library of Medicine. NCT01240200 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.