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

• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Novo Nordisk A/S
• Information provided by: University of Texas Southwestern Medical Center

Study Description

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: May 2009
• Estimated Primary Completion Date: December 2010
• Estimated Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Length of Hospitalization Stay [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. Cost of Hospitalization [ Time Frame: 18 months ]
2. All-Cause Mortality [ Time Frame: 18 months ]
3. Frequency of Hypoglycemic Episodes [ Time Frame: 18 months ]
4. Rate of Transfer to Telemetry Unity [ Time Frame: 18 months ]
5. Rate of Nosocomial Infections [ Time Frame: 18 months ]
6. Rate of Surgical Procedures [ Time Frame: 18 months ]
7. Rate of Re-hospitalization [ Time Frame: 18 months ]
8. Time to goal blood glucose level [ Time Frame: 18 months ]
9. Time to becoming medically stable for discharge [ Time Frame: 18 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Texas

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

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

Additional Information:

UT Southwestern Clinical Trials 

• 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
• First Posted: May 21, 2009
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

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; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir; Hypoglycemic Agents; Physiological Effects of Drugs