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Diabetic KetoacidosisPhase 4NCT00590044

Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

A Phase 4 study testing insulin glargine+ glulisine and NPH + Regular insulin in people with Diabetic Ketoacidosis, run by Emory University at 2 sites 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

The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Ketoacidosis
What is being tested?
insulin glargine+ glulisine and NPH + Regular insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesUnited States
Study dates
Dec 2007to Aug 2008
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA and who are willing to participate in the study protocol will be considered candidates for inclusion into the study.
  • Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to severe ketonemia (acetoacetate ≥ 1:4 or βeta-hydroxybutyrate > 3 mmol).

Who cannot join

  • Hemodynamic instability (MAP < 50 or patients requiring pressor)
  • Significant identifiable medical or surgical illness, including but not limited to: acute myocardial infarction, congestive heart failure; respiratory failure requiring mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0 mg/dl); end stage liver failure, and cirrhosis.
  • Patients with dementia or persistent altered mental status that would prevent collection of consent form and reliable information.
  • Pregnancy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • University of Minnesota School of Medicine

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Basal Insulin in the Management of Patients With Diabetic Ketoacidosis

The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

Read the detailed description

Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an estimated 100,000 admissions per year in the United States, DKA is also the leading cause of death in children with type 1 diabetes, and accounts for a significant proportion of admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies have reported successful protocols for insulin administration during the acute management of DKA, but they have failed to address the transition phase from IV to SC maintenance insulin regimen. The American Diabetes Association (ADA) position statement recommends the use of split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This regimen, however, are associated with a high rate of hyperglycemia shortly after discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently, the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been shown to facilitate glycemic control with lower rate of hypoglycemic events than intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i) to determine the effects of giving a dose of glargine insulin shortly after starting an intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient glycemic control in patients with DKA.

Being tested
insulin glargine+ glulisine, NPH + Regular insulin
Keywords
Diabetic ketoacidosis, insulin therapy, DKA
Medical subject headings
Diabetic Ketoacidosis

What participants receive

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

  • insulin glargine+ glulisineDrug

    Also called glargine (Lantus) + glulisine (Apidra)

    Daily insulin glargine + glulisine before meals

  • NPH + Regular insulinDrug

    Also called Isophane Insulin(NPH), Intermediate acting Insulin (NPH)

    Split-mixed NPH + Regular insulin twice daily

Study groups in NCT00590044
Study groupRoleWhat they receive
Insulin glargine+glulisineExperimentalDaily insulin glargine + glulisine before meals
Receives: Drug: insulin glargine+ glulisine
Split-mixed NPH + Regular insulinActive comparatorSplit-mixed NPH + Regular insulin twice daily
Receives: Drug: NPH + Regular insulin

What is being measured

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

  1. Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups

    To determine the safety of the two treatments the number of hypoglycemia episodes that occurred between the 2 groups are measured from the time of transitioning to subcutaneous insulin to day 5. The hypoglycemia events are defined as blood glucose levels <70 mg/dL. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.

    Measured: 5 days after transitioning to subcutaneous insulin

Secondary outcomes (3)

  1. Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin

    The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed Identification (ID): 19366972.

    Measured: Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin

  2. Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups

    To determine the differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA) before transitioning to subcutaneous insulin. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.

    Measured: up to 20 hours

  3. Difference in Time in Hours to Resolution of DKA Between the 2 Groups

    The mean duration of treatment until resolution of ketoacidosis is measured and compared between the 2 groups. The DKA was considered resolved when blood glucose was 250 mg/dl, the serum bicarbonate level was <18 mmol/l, and venous phenol hydroxylase (pH) was 7.30. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.

    Measured: up to 20 hours

Timeline

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

  1. First posted10 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2008
  4. Study completionAug 2008

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00590044
Sponsor's protocol ID
IRB00005062a
Status last verified
Aug 2018
First submitted
28 Dec 2007
Last updated
26 Sep 2018
Data monitoring committee
Yes

Publications

  • Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14.

    PubMed 19366972

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin glargine+ glulisine and NPH + Regular insulin in people with Diabetic Ketoacidosis, run by Emory University at 2 sites 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 2 inclusion and 4 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Apr 2009). 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?

Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups (time frame: 5 days after transitioning to subcutaneous insulin). 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 NCT00590044, which also lists 1 linked publication.

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 26 Sep 2018.

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