NCT00906529

Brief Summary

The purpose of this study is to determine whether aggressive (goal pre-prandial blood glucose \<110 mg/dl) versus conservative (goal pre-prandial blood glucose \<180mg/dl) diabetes treatment of type 2 diabetic patients on the general medical wards has any effect on hospital outcomes.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

May 8, 2009

Last Update Submit

January 15, 2019

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesInpatientLength of StayBlood Glucose Control

Outcome Measures

Primary Outcomes (1)

  • Length of Hospitalization Stay

    18 months

Secondary Outcomes (9)

  • Cost of Hospitalization

    18 months

  • All-Cause Mortality

    18 months

  • Frequency of Hypoglycemic Episodes

    18 months

  • Rate of Transfer to Telemetry Unity

    18 months

  • Rate of Nosocomial Infections

    18 months

  • +4 more secondary outcomes

Study Arms (2)

Conservative Blood Glucose Control

ACTIVE COMPARATOR

Goal Pre-prandial blood glucose \<180 mg/dl.

Drug: Levemir (Detemir) and Novolog (Aspart) Insulin

Aggressive Blood Glucose Control

ACTIVE COMPARATOR

Pre-prandial goal blood glucose \<110 mg/dl

Drug: Levemir (Detemir) and Novolog (Aspart) Insulin

Interventions

Levemir (Detemir) and Novolog (Aspart) InsulinDRUG

Will use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal

Also known as: Detemir, Aspart
Aggressive Blood Glucose ControlConservative Blood Glucose Control

Eligibility Criteria

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

You may qualify if:

  • Existing diagnosis of type 2 diabetes.
  • Admitted to a non-telemetry, non-ICU medicine inpatient bed.
  • Willing and able to give informed consent.
  • HgbA1c of any value will be accepted.

You may not qualify if:

  • Type 1 diabetes
  • Admitted to a telemetry, ICU, or non-medicine inpatient bed (e.g., surgery, neurosurgery, obstetrics/gynecology, psychiatry).
  • Diabetic ketoacidosis (arterial ph \<7.24, serum bicarbonate \<15, positive serum ketones, anion gap \>12)
  • Hyperosmolar hyperglycemic state (blood glucose \>200 mg/dl, serum osmolarity \>320 mOsm/kg)
  • Inability to cooperate with study personnel.
  • Known allergy or intolerance to detemir or novolog.
  • Admission to the hospital \>24 hours from entry into the study.
  • Admission to the hospital for inpatient hospice care.
  • Admission/continued admission to the hospital for procurement of a guardian.
  • Admission/continued admission to the hospital for rehabilitation.
  • Patients admitted with the diagnosis of acute coronary syndrome.
  • Patients admitted with the diagnosis of acute cerebrovascular accident.
  • Patients currently pregnant or breast-feeding.
  • Patients not fluent in English or Spanish as it will be difficult to obtained written informed consent in another language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin AspartInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-ActingProinsulin

Study Officials

  • Steve Fordan, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

  • John Richard, MD

    University of Texas Southwestern Medical Center

    STUDY DIRECTOR

  • Philip Raskin, MD

    University of Texas Southwestern Medical Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 21, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)