DiabetesPhase 1NCT01153100
Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
A Phase 1 study testing Glargine in people with Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators anticipate that the use of Glargine 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?
- Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
- Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
- Patients with both types of diabetes will be among those treated with the 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 drip 2 weeks and longer, pregnancy, Lantus allergy, and concurrent sulfonamide treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
The investigators anticipate that the use of Glargine 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.
- Conditions
- Diabetes
- Being tested
- Glargine
- 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.
GlargineDrug
Also called Lantus
Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard insulin drip therapy | No intervention | Standard insulin drip therapy |
| Insulin drip and glargine | Active comparator | Insulin drip and glargine 0.25 units per kg body weight Receives: Drug: Glargine |
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)
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.
- First posted29 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Boris Draznin, MD, Principal investigator, Univesity of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153100
- Sponsor's protocol ID
- 09-1065
- Status last verified
- Oct 2019
- First submitted
- 14 Jun 2010
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
- ClinicalTrials.gov ID
- NCT01153100
- Acronym / sponsor ID
- 09-1065
- Conditions
- Diabetes
- Keywords
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators anticipate that the use of Glargine 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.
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 | –Standard insulin drip therapy |
| Insulin drip and glargine | Active comparator | Drug: GlargineInsulin drip and glargine 0.25 units per kg body weight |
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 hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
- Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
- Patients with both types of diabetes will be among those treated with the 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 drip 2 weeks and longer, pregnancy, Lantus 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 |
|---|---|---|
| GlargineAlso: LantusGlargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy | Drug | Insulin drip and glargine |
Primary outcome
Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)
Time frame: within 48 hours of discontinuation
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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 principal investigator
Univesity of Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glargine 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 1 Nov 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 1 Nov 2019.