Prandial Insulin Dosing in Hospitalized Patients

NCT ID: NCT01101867

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-03-31

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.

Detailed Description

The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Conditions

Diabetes; Admitting Hospital; Non-critically Ill

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspart flexible dose

aspart dose determined based upon carbohydrate intake.

Group Type: EXPERIMENTAL

Aspart flexible dose

Intervention Type: DRUG

dose based upon carbohydrate intake and total daily requirements

Aspart fixed dose

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

Group Type: ACTIVE_COMPARATOR

Aspart fixed dose

Intervention Type: DRUG

fixed dose

Interventions

Aspart fixed dose

fixed dose

Intervention Type: DRUG

Aspart flexible dose

dose based upon carbohydrate intake and total daily requirements

Intervention Type: DRUG

Other Intervention Names

Novolog; Novolog

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Kathleen Dungan

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Dungan

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathleen M Dungan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

Novo Nordisk xxxx

Identifier Type: -

Identifier Source: org_study_id