Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin

NCT ID: NCT00906529

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-03-31

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.

Detailed Description

Objective: The objective of this study is to determine the effect of an "aggressive" blood glucose control (goal pre-prandial CBG <110 mg/dl) versus a "conservative" blood glucose control (goal pre-prandial CBG <180 mg/dl) on length of stay in hospitalized type 2 diabetic patients using levemir (detemir) and novolog (aspart) insulins.

Study Site: Parkland Memorial Hospital, 5201 Harry Hines Blvd, Dallas, Texas 75235. Parkland Hospital is a 720 adult bed public hospital that serves as the main teaching hospital for the University of Texas-Southwestern Medical Center. In addition, Parkland Memorial Hospital possesses the University Diabetes Treatment Center, an eleven bed medical ward devoted to inpatient diabetes management. This study will be conducted throughout all of Parkland's general medical floors, including the University Diabetes Treatment Center.

Patient Population: The population for this study includes men and women with type 2 diabetes admitted to the general medicine wards of Parkland Memorial Hospital.

Study Design and Duration: This is a single-center, randomized, single blind, non-inferiority study design.

Patients admitted to Parkland Hospital with type 2 diabetes will be recruited to the study within 24 hours of admission. Gravid patients, patients in DKA, or HHS will be excluded. All patients will be evaluated for inclusion and exclusion criteria. During the hospitalization, patients will be stratified by age and admitting diagnosis and randomized to either an "aggressive" blood glucose control (goal pre-prandial CBG <110 mg/dl) or a "conservative" blood glucose control (goal pre-prandial CBG <180 mg/dl). Subcutaneous detemir and novolog will be employed according to the enclosed protocol to meet the goal blood glucose level. The insulin will be administered by nursing staff via the FlexPen, a pre-filled pen-like insulin delivery device. CBGs will be obtained before breakfast, before lunch, before supper, and at bedtime. If a patient is NPO, then the CBGs will be obtained at the time that the patient was to have eaten.

Treatment of the patient's primary admitting diagnosis including plan and procedures will be completely at the primary team's discretion.

Should a patient require transfer to an intensive care unit or to a telemetry unit, then the patient's participation in the study will be held until discharge from said unit. While the patient is in an ICU or telemetry unit, the blood glucose goal and management will be completely decided upon by the primary team.

The study will terminate at the end of the hospitalization.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conservative Blood Glucose Control

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

Group Type: ACTIVE_COMPARATOR

Levemir (Detemir) and Novolog (Aspart) Insulin

Intervention Type: DRUG

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

Aggressive Blood Glucose Control

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

Group Type: ACTIVE_COMPARATOR

Levemir (Detemir) and Novolog (Aspart) Insulin

Intervention Type: DRUG

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

Interventions

Levemir (Detemir) and Novolog (Aspart) Insulin

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

Intervention Type: DRUG

Other Intervention Names

Detemir; Aspart

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

University of Texas Southwestern Medical School

Principal Investigators

Steve Fordan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

John Richard, MD

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

Philip Raskin, MD

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center

Locations

Parkland Memorial Hospital

Dallas, Texas, United States

Countries

United States

Related Links

http://www.utsouthwestern.edu/utsw/cda/dept226287/files/308724.html

UT Southwestern Clinical Trials

Other Identifiers

Novo 092

Identifier Type: -

Identifier Source: org_study_id