Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

NCT00717288 | Completed Phase 4 Results DMC

• 2 other identifiers: 2007H021060016576
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).

Conditions

Diabetes Mellitus

Keywords

diabetes; hyperglycemia; open heart surgery; cardiothoracic surgery; detemir; insulin infusion; intravenous insulin

Outcome Measures

Primary Outcomes (1)

• Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3

  Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3

  day 2, day 3

Secondary Outcomes (2)

• Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)

  48 hours

• Reversion to Intravenous Insulin for Failure of Glycemic Control

  72 hours

Study Arms (3)

1

ACTIVE COMPARATOR

Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily

Drug: Detemir

2

ACTIVE COMPARATOR

Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily

Drug: Detemir

3

ACTIVE COMPARATOR

Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily

Drug: Detemir

Interventions

Detemir DRUG

Detemir dosed at 50% of calculated basal insulin infusion requirements

Also known as: Levemir

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes mellitus
• post-cardiothoracic surgery
• requiring an insulin infusion of at least 1 unit/hour
• Age 18-75

You may not qualify if:

• Glucocorticoids
• total parenteral nutrition (TPN) or tube feeds
• Pregnancy
• Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
• Expected length of stay less than 48 hours following cessation of the insulin drip
• Patients using subcutaneous insulin pumps
• Diabetic ketoacidosis
• End-stage renal disease
• End-stage liver disease
• Coma
• Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
• Unable to give consent in English

Sponsors & Collaborators

• Ohio State University: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kathleen Dungan, MD
• Organization: The Ohio State University

kathleen.dungan@osumc.edu

614-292-3800

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 3, 2011
• Results First Posted: October 3, 2011

Record last verified: 2011-08

Locations

US (1)