Diabetes MellitusPhase 4NCT01240200

Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

A Phase 4 study testing Glargine and glargine via insulin pen in people with Diabetes Mellitus, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: Glargine and glargine via insulin pen
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Dec 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Grady Memorial Hospital
Atlanta, Georgia, 30303

Other trials in United States

About this study

Official title: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy Using Pens for a Basal Insulin Treatment (STEP IT UP a BIT)

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
Being tested: Glargine, glargine via insulin pen
Keywords: diabetes, elderly, insulin injections
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlargineDrug
Also called Lantus
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
glargine via insulin penDevice
Also called Solostar
oral antidiabetic agents plus insulin glargine in a pre-filled pen

Study groups in NCT01240200
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Glargine; Device: glargine via insulin pen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 24

Secondary outcomes (4)

Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) measures the average percentage of blood sugar over the past 2 to 3 months. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. HbA1c can reduce with management of diabetes through diet, exercise, and medication.
Measured: Baseline, Week 12
Fasting Blood Glucose
Blood sugar levels are influenced by the size and types of food consumed during the last meal and the production and response to insulin. Fasting blood glucose levels of less than 100 milligrams per deciliter (mg/dL) are considered normal. Values between 100 and 125 mg/dL indicate prediabetes and values of 126 mg/dL and higher indicate diabetes. Fasting blood glucose levels can lower depending on food consumed and medications.
Measured: Baseline, Week 12
Percent of Participants With Dosing Errors
Percentage of participants who had dosing errors during the course of the study (both study periods). Participants were instructed on using each device and practiced preparing and injecting the insulin dose into a pillow to assess accuracy with each method of delivering insulin. Dosing errors were defined as inaccurate preparation or injection by less than or equal to 10% of the intended dose, independent of vision and dexterity function.
Measured: Week 24
Number of Hypoglycemic Events
The number of hypoglycemic events occurring during the 24-week study period is reported here. For the purposes of this study, hypoglycemia is defined as a capillary and/or laboratory blood glucose value of less than 70 mg/dL.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Dec 2012

First posted15 Nov 2010 (estimated)
Study startJan 2011
Primary completionAug 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240200
Sponsor's protocol ID: IRB00046366
Status last verified: Oct 2018
First submitted: 9 Nov 2010
Last updated: 31 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy Using Pens for a Basal Insulin Treatment (STEP IT UP a BIT)
ClinicalTrials.gov ID: NCT01240200
Acronym / sponsor ID: IRB00046366
Conditions: Diabetes Mellitus
Keywords: diabetes, elderly, insulin injections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Sanofi
Study start: Jan 2011
Primary completion: Aug 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 15 Nov 2010 (estimated)
Results: Posted 30 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vial & Syringe (Period 1) / Pen (Period 2)	Active comparator	Drug: Glargine, Device: glargine via insulin penCrossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
Pen (Period 1) / Vial & Syringe (Period 2)	Experimental	Drug: Glargine, Device: glargine via insulin penCrossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GlargineAlso: Lantusoral antidiabetic agents plus once daily insulin glargine via an insulin syringe	Drug	Pen (Period 1) / Vial & Syringe (Period 2), Vial & Syringe (Period 1) / Pen (Period 2)
glargine via insulin penAlso: Solostaroral antidiabetic agents plus insulin glargine in a pre-filled pen	Device	Pen (Period 1) / Vial & Syringe (Period 2), Vial & Syringe (Period 1) / Pen (Period 2)

Primary outcome

Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
Time frame: Baseline, Week 12
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.
Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score
Time frame: Week 24
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.

4 secondary outcomes

Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 12
Fasting Blood Glucose
Time frame: Baseline, Week 12
Percent of Participants With Dosing Errors
Time frame: Week 24
Number of Hypoglycemic Events
Time frame: Week 24

Results and safety

Results posted to the registry on 30 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vial & Syringe (Period 1) / Pen (Period 2)	25	23
Pen (Period 1) / Vial & Syringe (Period 2)	24	23

Primary outcome: Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Vial & Syringe (Period 1) / Pen (Period 2) n = 23	Pen (Period 1) / Vial & Syringe (Period 2) n = 23
Baseline	28.2 (7.0)	31.5 (4.9)
Week 12	32.2 (5.2)	34.2 (2.3)

Population analysed: This analysis includes participants who completed the baseline and week 12 assessments.

Primary outcome: Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score

Time frame: Week 24. Mean (Standard Deviation). Unit: units on a scale

Measure	Vial & Syringe (Period 1) / Pen (Period 2) n = 23	Pen (Period 1) / Vial & Syringe (Period 2) n = 23
Value	16.4 (2.7)	-2.3 (10.0)

Population analysed: This analysis includes participants who completed the week 12 and week 24 assessments.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time study treatment began through the completion of both 12-week periods of the study (up to 24 weeks). Twenty-five participants began the vial and syringe delivery method in Period 1 and 23 participants began this intervention in Period 2, resulting in 48 participants receiving this intervention. For the insulin pen delivery method, 24 participants began in Period 1 and 23 began in Period 2, for a total of 47 participants receiving this intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vial and Syringe	0 of 48 (0%)	22 of 48 (45.8%)	0 of 48
SoloSTAR Pen	0 of 47 (0%)	15 of 47 (31.9%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christoper Newton, MD principal investigator

Emory University SOM

Dawn Smiley, MD, MSCR principal investigator

Emory University SOM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glargine and glargine via insulin pen in people with Diabetes Mellitus, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01240200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.