Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01153100

Enrollment

Registered

2010-06-29

Start date

2010-04-30

Completion date

2012-02-29

Last updated

2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes

Brief 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.

Interventions

DRUGGlargine

Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)	within 48 hours of discontinuation

Secondary

Measure	Time frame
Reduction in duration of insulin drip therapy and reduction in total and average per hour insulin drip dose	within one week of insulin drip therapy
Reduction in ICU length of stay	within two weeks of hospitalization
Equal or improved diabetes control	within two weeks of hospitalization
Reduction in time to get back to control of glycemia (140-180 mg/dl) if rebound hyperglycemia occurs	within one week post insulin drip

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026