NCT00528918

Brief Summary

The purpose of this study is to compare Apidra (a rapid acting insulin analogue) with Regular insulin (fast acting) in addition to the use of long acting insulin Glargine in hospitalized patients in terms of efficacy and safety in blood glucose control and frequency of low blood glucose. Blood glucose control along with incidence and rate of low blood glucose during the hospitalization shall be of primary interest; length of hospital stay comparing the short acting insulin used shall be the secondary interest.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 24, 2014

Status Verified

August 1, 2007

Enrollment Period

3.9 years

First QC Date

September 11, 2007

Last Update Submit

July 23, 2014

Conditions

Diabetes Mellitus, Type II

Keywords

diabeteshyperglycemiainsulinApidraGlargine

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemic events

    up to 60 days

Study Arms (2)

Apidra

ACTIVE COMPARATOR

Direct 1:1 comparison of Apidra and Regular insulin.

Drug: Glulisine (Apidra)

Regular

ACTIVE COMPARATOR

Direct 1:1 comparison of Apidra and Regular insulin.

Drug: Glulisine (Apidra)

Interventions

Glulisine (Apidra)DRUG

An algorithm to determine the initial doses of insulin and dose adjustments is as follows: Lean subjects (BMI less than 25 kg/m2) will initially receive a total of 0.4 units/kg/day, overweight subjects (BMI 25-30 kg/m2) 0.5 units/kg/day and obese subjects (BMI greater than 30 kg/m2) 0.6 units/kg/day. Fifty percent of the total amount of insulin will be given as Glargine and 50% as regular insulin or Apidra. Supplemental short-acting insulin will be given for hyperglycemia before meals. Automated order sets shall be generated to minimize errors in order entries. Glucose concentrations will be measured before each meal and at bedtime, and if symptomatic. In addition, eight-point blood glucose profiles will be obtained every three days starting on day 2. Dose adjustments will be made to keep blood glucose concentrations between 80 and 120 mg/dl pre-prandially and less than180 mg/dl after meals.

ApidraRegular

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be admitted to non-critical care units with expected length of stay of at least three days.
  • Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  • Subjects may be of either sex. Female subjects of child-bearing potential must be non-lactating and have a negative pregnancy test before starting the study.
  • Subjects must be diagnosed with T2DM or develop hyperglycemia (BG \>180 mg/dl) during hospitalization.

You may not qualify if:

  • Subjects must not be admitted for 'observation' or for expected length of stay of less than three days.
  • Subjects must not have Type 1 Diabetes.
  • Subjects must not be using rapid acting insulin analogues.
  • Subjects must not be receiving nutrition via tube feedings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Related Publications (1)

  • Meyer C, Boron A, Plummer E, Voltchenok M, Vedda R. Glulisine versus human regular insulin in combination with glargine in noncritically ill hospitalized patients with type 2 diabetes: a randomized double-blind study. Diabetes Care. 2010 Dec;33(12):2496-501. doi: 10.2337/dc10-0957. Epub 2010 Aug 30.

    PMID: 20805258DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusHyperglycemiaInsulin Resistance

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Christian Meyer, MD

    Carl T. Hayden VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

June 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 24, 2014

Record last verified: 2007-08

Locations

US(1)