Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

A study testing Detemir 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.

Trial summary

The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued. Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Diabetes
What is being tested?: Detemir
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Aug 2010to May 2014
Phase: Interventional
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 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.
Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition
Patients will be of age 19 to 80.

Who cannot join

Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment

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: Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment

Conditions: Diabetes
Being tested: Detemir
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.

DetemirDrug
Also called Levimir
Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy

Study groups in NCT01186003
Study group	Role	What they receive
Standard insulin drip therapy	No intervention	Not described
Insulin drip and Detemir	Active comparator	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy Receives: Drug: Detemir

What is being measured

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

Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl)
Measured: within 48 hours of discontinuation

Secondary outcomes (4)

Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose
Measured: within one week of insulin drip therapy
Reduction in ICU Length of Stay
Measured: within two weeks of hospitalization
Equal or Improved Diabetes Control
Measured: within two weeks of hospitalization
Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs
Measured: within one week post insulin drip

Timeline

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

Aug 2010May 2014

First posted20 Aug 2010 (estimated)
Study startAug 2010
Primary completionMay 2014
Study completionMay 2014

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01186003
Sponsor's protocol ID: 10-0483
Status last verified: Nov 2021
First submitted: 19 Aug 2010
Last updated: 7 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
ClinicalTrials.gov ID: NCT01186003
Acronym / sponsor ID: 10-0483
Conditions: Diabetes
Keywords: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Novo Nordisk A/S
Study start: Aug 2010 (actual)
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 20 Aug 2010 (estimated)
Results: Posted 7 Dec 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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard insulin drip therapy	No intervention	–
Insulin drip and Detemir	Active comparator	Drug: DetemirDetemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.
Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition
Patients will be of age 19 to 80.

Key exclusion criteria (1 listed)

Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment

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
DetemirAlso: LevimirDetemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy	Drug	Insulin drip and Detemir

Primary outcome

Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
Time frame: within 48 hours of discontinuation
Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl)

4 secondary outcomes

Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose
Time frame: within one week of insulin drip therapy
Reduction in ICU Length of Stay
Time frame: within two weeks of hospitalization
Equal or Improved Diabetes Control
Time frame: within two weeks of hospitalization
Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs
Time frame: within one week post insulin drip

Results and safety

Results posted to the registry on 7 Dec 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
Standard Insulin Drip Therapy	14	14
Insulin Drip and Detemir	16	16

Primary outcome: Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)

Time frame: within 48 hours of discontinuation. Count of participants. Unit: Participants

Measure	Standard Insulin Drip Therapy n = 14	Insulin Drip and Detemir n = 16
Value	14	3

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Insulin Drip Therapy	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Insulin Drip and Detemir	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Limitations and caveats (from the sponsor): We have no information regarding whether many of the outcome measure were collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, several outcome measures cannot be reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes

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Recruiting
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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, MD., Ph.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 study testing Detemir 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 4 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 7 Dec 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 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?

Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) (time frame: within 48 hours of discontinuation). 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 NCT01186003.

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 7 Dec 2021.