Type 2 DiabetesPhase 4RASCINNCT00906529
Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin
A Phase 4 study testing Levemir (Detemir) and Novolog (Aspart) Insulin in people with Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Levemir (Detemir) and Novolog (Aspart) Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Levemir (Detemir) and Novolog (Aspart) Insulin
- Keywords
- Type 2 Diabetes, Inpatient, Length of Stay, Blood Glucose Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levemir (Detemir) and Novolog (Aspart) InsulinDrug
Also called Detemir, Aspart
Will use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal
| Study group | Role | What they receive |
|---|---|---|
| Conservative Blood Glucose Control | Active comparator | Goal Pre-prandial blood glucose <180 mg/dl. Receives: Drug: Levemir (Detemir) and Novolog (Aspart) Insulin |
| Aggressive Blood Glucose Control | Active comparator | Pre-prandial goal blood glucose <110 mg/dl Receives: Drug: Levemir (Detemir) and Novolog (Aspart) Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization Stay
Measured: 18 months
Secondary outcomes (9)
Cost of Hospitalization
Measured: 18 months
All-Cause Mortality
Measured: 18 months
Frequency of Hypoglycemic Episodes
Measured: 18 months
Rate of Transfer to Telemetry Unity
Measured: 18 months
Rate of Nosocomial Infections
Measured: 18 months
Rate of Surgical Procedures
Measured: 18 months
Rate of Re-hospitalization
Measured: 18 months
Time to goal blood glucose level
Measured: 18 months
Time to becoming medically stable for discharge
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Investigators
- Steve Fordan, MD, Principal investigator, University of Texas Southwestern Medical CenterJohn Richard, MD, Study director, University of Texas Southwestern Medical CenterPhilip Raskin, MD, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906529
- Sponsor's protocol ID
- Novo 092
- Acronym
- RASCIN
- Status last verified
- Jan 2019
- First submitted
- 8 May 2009
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00906529
- Acronym / sponsor ID
- RASCIN / Novo 092
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Inpatient, Length of Stay, Blood Glucose Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- May 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Blood Glucose Control | Active comparator | Drug: Levemir (Detemir) and Novolog (Aspart) InsulinGoal Pre-prandial blood glucose <180 mg/dl. |
| Aggressive Blood Glucose Control | Active comparator | Drug: Levemir (Detemir) and Novolog (Aspart) InsulinPre-prandial goal blood glucose <110 mg/dl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levemir (Detemir) and Novolog (Aspart) InsulinAlso: Detemir, AspartWill use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal | Drug | Aggressive Blood Glucose Control, Conservative Blood Glucose Control |
Primary outcome
Length of Hospitalization Stay
Time frame: 18 months
9 secondary outcomes
Cost of Hospitalization
Time frame: 18 months
All-Cause Mortality
Time frame: 18 months
Frequency of Hypoglycemic Episodes
Time frame: 18 months
Rate of Transfer to Telemetry Unity
Time frame: 18 months
Rate of Nosocomial Infections
Time frame: 18 months
Rate of Surgical Procedures
Time frame: 18 months
Rate of Re-hospitalization
Time frame: 18 months
Time to goal blood glucose level
Time frame: 18 months
Time to becoming medically stable for discharge
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- UT Southwestern Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Fordan, MD principal investigator
University of Texas Southwestern Medical Center
John Richard, MD study director
University of Texas Southwestern Medical Center
Philip Raskin, MD study chair
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levemir (Detemir) and Novolog (Aspart) Insulin in people with Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospitalization Stay (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.