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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00906529
First received: May 8, 2009
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Levemir (Detemir) and Novolog (Aspart) Insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: RAndomized SubCutaneous Insulin in INpatients (RASCIN) Trial: Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Length of Hospitalization Stay [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of Hospitalization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • All-Cause Mortality [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Frequency of Hypoglycemic Episodes [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Rate of Transfer to Telemetry Unity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Rate of Nosocomial Infections [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Rate of Surgical Procedures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Rate of Re-hospitalization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Time to goal blood glucose level [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time to becoming medically stable for discharge [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conservative Blood Glucose Control
Goal Pre-prandial blood glucose <180 mg/dl.
Drug: Levemir (Detemir) and Novolog (Aspart) Insulin
Will use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal
Other Names:
  • Detemir
  • Aspart
Active Comparator: Aggressive Blood Glucose Control
Pre-prandial goal blood glucose <110 mg/dl
Drug: Levemir (Detemir) and Novolog (Aspart) Insulin
Will use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal
Other Names:
  • Detemir
  • Aspart

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906529

Contacts
Contact: Steve Fordan, MD 214 648-4562 steve.fordan@utsouthwestern.edu
Contact: Ben Edens 214 648-4716 ben.edens@utsouthwestern.edu

Locations
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Steve Fordan, MD    214-648-4562    steve.fordan@utsouthwestern.edu   
Contact: Valeria Hart, PhD    214-590-8966    VHART@parknet.pmh.org   
Principal Investigator: Steve Fordan, MD         
Sub-Investigator: John Richard, MD         
Sub-Investigator: Chanhaeng Rhee, MD         
Principal Investigator: Philip Raskin, MD         
Sub-Investigator: Alok Mohan, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Novo Nordisk A/S
Investigators
Principal Investigator: Steve Fordan, MD University of Texas Southwestern Medical Center
Study Director: John Richard, MD University of Texas Southwestern Medical Center
Study Chair: Philip Raskin, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Steve Fordan, MD/Principal Investigator, University of Texas Southwestern Medical School
ClinicalTrials.gov Identifier: NCT00906529     History of Changes
Other Study ID Numbers: Novo 092
Study First Received: May 8, 2009
Last Updated: May 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Type 2 Diabetes
Inpatient
Length of Stay
Blood Glucose Control

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014