NCT01101867

Brief Summary

The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Jun 2010

Typical duration for phase_4 diabetes

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

First Submitted

Initial submission to the registry

April 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 2, 2013

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

April 8, 2010

Results QC Date

April 9, 2013

Last Update Submit

January 3, 2018

Conditions

DiabetesAdmitting HospitalNon-critically Ill

Keywords

diabetesglucosehospital

Outcome Measures

Primary Outcomes (1)

  • Mean Glucose

    Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3

    day 3

Secondary Outcomes (5)

  • Postprandial Glucose

    day 3

  • Hypoglycemia

    72 hour

  • Change in Glucose

    72 hour

  • Treatment Satisfaction

    day 3

  • 1,5-anhydroglucitol Change

    day 1 to day 3

Study Arms (2)

Aspart flexible dose

EXPERIMENTAL

aspart dose determined based upon carbohydrate intake.

Drug: Aspart flexible dose

Aspart fixed dose

ACTIVE COMPARATOR

fixed meal dose of aspart (based upon weight or total daily insulin dose)

Drug: Aspart fixed dose

Interventions

Aspart fixed doseDRUG

fixed dose

Also known as: Novolog
Aspart fixed dose
Aspart flexible doseDRUG

dose based upon carbohydrate intake and total daily requirements

Also known as: Novolog
Aspart flexible dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • general medical or minor surgical hospitalized patients
  • type 2 diabetes
  • blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment

You may not qualify if:

  • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).
  • Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
  • Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
  • Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
  • Prolonged (\>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
  • Patients for whom expected length of stay will be less than 48 hours
  • Patients using subcutaneous insulin pumps
  • Diabetic ketoacidosis
  • End-stage renal disease on dialysis
  • End-stage liver disease with cirrhosis
  • Mental conditions precluding informed consent
  • Potentially sensitive admissions: prisoners, HIV, suicidality
  • Unable to give consent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

Miscalculation of meal doses, mistimed doses, lack of complete documentation of carbohydrate intake, and dosing conducted by an experienced clinician may have contributed to the findings.

Results Point of Contact

Title
Dr. Kathleen Dungan
Organization
The Ohio State University
kathleen.dungan@osumc.edu
614-685-3333

Study Officials

  • Kathleen M Dungan, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 12, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

March 1, 2013

Last Updated

January 31, 2018

Results First Posted

July 2, 2013

Record last verified: 2018-01

Locations

US(1)