DiabetesPhase 4NCT01203774

Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital

A Phase 4 study testing Glargine insulin in people with Diabetes, run by University of Colorado, Denver 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

In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. Read more about this study

Who is it for?: Ages 22 to 70 years
Conditions the study is for: Diabetes
What is being tested?: Glargine insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Aug 2013
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 22 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine

Who cannot join

Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: "Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients Discharged From the Hospital"

Conditions: Diabetes
Being tested: Glargine insulin
Keywords: Diabetes
Medical subject headings: Diabetes Mellitus

What participants receive

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

Glargine insulinDrug
20-180 units per day

Study groups in NCT01203774
Study group	Role	What they receive
Pen-administered vs syringe-admnistered Glargine	Active comparator	SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Receives: Drug: Glargine insulin
Syringe-administered vs pen-administered Glargine	Active comparator	Syringe-administered Glargine insulin and then pen-administered Glargine insulin Receives: Drug: Glargine insulin

What is being measured

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

HbA1c at Three Months of Each Period of Treatment
Data was collected by group
Measured: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)

Secondary outcomes (1)

Compliance and Patient Satisfaction
Measured: 6 months of treatment after discharge from the hospital

Timeline

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

Sep 2010Aug 2013

First posted16 Sep 2010 (estimated)
Study startSep 2010
Primary completionAug 2013
Study completionAug 2013

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 DiabetesStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe 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: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01203774
Sponsor's protocol ID: 10-0788
Status last verified: Jul 2021
First submitted: 15 Sep 2010
Last updated: 6 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients Discharged From the Hospital"
ClinicalTrials.gov ID: NCT01203774
Acronym / sponsor ID: 10-0788
Conditions: Diabetes
Keywords: Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Sanofi
Study start: Sep 2010
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 16 Sep 2010 (estimated)
Results: Posted 6 Aug 2021

Clinical summary

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

Study design

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

Arm	Type	Receives
Pen-administered vs syringe-admnistered Glargine	Active comparator	Drug: Glargine insulinSoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin
Syringe-administered vs pen-administered Glargine	Active comparator	Drug: Glargine insulinSyringe-administered Glargine insulin and then pen-administered Glargine insulin

Who may qualify

Ages: 22 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine

Key exclusion criteria (1 listed)

Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness

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
Glargine insulin20-180 units per day	Drug	Pen-administered vs syringe-admnistered Glargine, Syringe-administered vs pen-administered Glargine

Primary outcome

HbA1c at Three Months of Each Period of Treatment
Time frame: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)
Data was collected by group

1 secondary outcome

Compliance and Patient Satisfaction
Time frame: 6 months of treatment after discharge from the hospital

Results and safety

Results posted to the registry on 6 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pen-administered, Then Syringe-admnistered Glargine	21	21
Syringe-administered Then Pen-administered Glargine	10	10

Primary outcome: HbA1c at Three Months of Each Period of Treatment

Time frame: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2). Mean (Standard Deviation). Unit: percentage (DCCT unit)

Measure	Group 1: Pen-administered, Then Syringe-admnistered Glargine n = 21	Group 2: Syringe-administered Then Pen-administered Glargine n = 10
Baseline HbA1c	10.7 (2.2)	11.2 (2.5)
HbA1C at 3 months (end of intervention 1, before crossover)	7.8 (1.7)	7.3 (1.4)
HbA1c at 6 Months (end of dose 2, after crossover)	8.5 (2.0)	7.1 (1.6)

Population analysed: The only outcome measure available for this measurement is "by group". This measure cannot be entered "by intervention" (e.g. Arm 1: "Pen", Arm 2: "Syringe"). Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. Participants that did not complete the study are not included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pen-administered Glargine	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Syringe-administered Glargine	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): Limited results information is available. Multiple attempts were made to obtain this information, however the PI is retired and additional data could not be obtained from any remaining personnel associated with the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Recruiting
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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.

Boris Draznin, M.D. principal investigator

University of Colorado, Denver

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 insulin in people with Diabetes, run by University of Colorado, Denver 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 1 inclusion and 1 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 6 Aug 2021. 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 6 Aug 2021). 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?

HbA1c at Three Months of Each Period of Treatment (time frame: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)). 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 NCT01203774.

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 6 Aug 2021.