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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Completed
Phase 1

Conditions

Diabetes

Treatments

Drug: Glargine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01153100
09-1065

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Standard insulin drip therapy
No Intervention group
Description:
Standard insulin drip therapy
Insulin drip and glargine
Active Comparator group
Description:
Insulin drip and glargine 0.25 units per kg body weight
Treatment:
Drug: Glargine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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