Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Medical University of South Carolina | OTHER |
| Texas A&M University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.
High blood glucose levels in medical and surgery patients with diabetes are associated with increased risk of in-hospital complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Numerous studies have shown that high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). The investigators' recent preliminary data also indicate that a single daily dose of glargine plus corrective doses of glulisine before meals if needed (Basal Plus) is effective in the management of medical and surgical patients with type 2 diabetes mellitus (T2DM). The average daily blood glucose (BG) levels in patients treated with Basal Plus is equivalent to levels in patients treated with Basal Bolus with glargine once daily plus glulisine before meals (basal bolus regimen). The mean daily BG levels in patients treated with basal plus are lower than those reported in patients treated with sliding scale regular insulin (SSRI). Accordingly, the present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes admitted to general medicine wards. Glargine, glulisine, and regular insulins are approved for use in the treatment of patients with diabetes by the FDA. A total of 375 subjects with type 2 diabetes will be recruited in this study. The sites for this study are Grady Memorial Hospital, Emory University Hospital, the Atlanta VA Medical Center, Scott & White Memorial Hospital and Clinic, and Medical University of South Carolina.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal Plus Regimen | Experimental | glargine subcutaneously once daily plus corrective doses of glulisine subcutaneously before meals and bedtime as needed |
|
| Basal Bolus | Experimental | glargine subcutaneously once daily plus glulisine subcutaneously before meals (plus corrective doses of glulisine as needed) |
|
| sliding scale regular insulin (SSRI) | Active Comparator | sliding scale regular insulin subcutaneously four-times daily in patients with T2DM admitted to general medicine and surgery wards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sliding scale regular insulin (SSRI) | Drug | four-time daily in patients with T2DM admitted to general medicine and surgery wards. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments | The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG >126 mg/dl or random BG >200 mg/dl on two or more occasions). | Randomization and 24 hrs after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments | Effective Glycemic control is also assessed by number of hypoglycemia events among the patients treated with Basal plus, basal-bolus and SSRI treatments. Hypoglycemia event is defined as blood glucose levels <70 mg/dL. Number of patients with hypoglycemia episodes that are treated with Basal plus, basal-bolus and SSRI treatment regimens during their hospital stay are examined and compared. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23435159 | Result | Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22. | |
| 25168125 |
Not provided
Not provided
24 subjects that were consented were withdrawn from the study and not included in analysis because they meet exclusion criteria like transferring to ICU; receiving treatment < 24 hrs and for receiving steroids
375 subjects were enrolled in the study from January 2010 to June 2012. The study is conducted in 3 states and patients were enrolled from 3 hospitals in state of Georgia; 1 hospitals in south Carolina and 1 hospitals in Texas.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Basal Bolus | glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) |
| FG001 | Basal Plus Regimen | glargine once daily plus corrective doses of glulisine before meals and bedtime as needed Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
| FG002 | Sliding Scale Regular Insulin (SSRI) | four-time daily in patients with T2DM admitted to general medicine and surgery wards. sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Basal Bolus | glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 units/kg/day (plus corrective doses of glulisine as needed) |
| BG001 | Basal Plus Regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments | The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG >126 mg/dl or random BG >200 mg/dl on two or more occasions). | Posted | Mean | Standard Deviation | mg/dL | Randomization and 24 hrs after treatment |
|
The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of < 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of < 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG >126 mg/dl or random BG >200 mg/dl on two or more occasions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Basal Plus Regimen | glargine once daily plus corrective doses of glulisine before meals and bedtime as needed Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment | blood glucose < 40 mg/dl |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment | blood glucose < 70 mg/dl |
- The study excluded patients admitted to the ICU, those with clinically relevant hepatic disease or with serum creatinine >3.0 mg/dL, patients with severe hyperglycemia, and those receiving a total dose of insulin >0.4 units/kg/day before admission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez | EUSOM | 4047781665 | geumpie@emory.edu |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| D000069036 | Insulin Glargine |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Basal Bolus | Drug | glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) |
|
|
| Basal Plus | Drug | glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
|
|
| During hospital stay, up to 12 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30030 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-6240 | United States |
| Scott & White Memorial Hospital and Clinic | Temple | Texas | 76508 | United States |
| Derived |
| Umpierrez GE, Reyes D, Smiley D, Hermayer K, Khan A, Olson DE, Pasquel F, Jacobs S, Newton C, Peng L, Fonseca V. Hospital discharge algorithm based on admission HbA1c for the management of patients with type 2 diabetes. Diabetes Care. 2014 Nov;37(11):2934-9. doi: 10.2337/dc14-0479. Epub 2014 Aug 28. |
| transferred to ICU |
|
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed |
| BG002 | Sliding Scale Regular Insulin (SSRI) | four-time daily in patients with T2DM admitted to general medicine and surgery wards. sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Basal Plus Regimen | glargine once daily plus corrective doses of glulisine before meals and bedtime as needed Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
| OG001 | Basal Bolus | glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) |
| OG002 | Sliding Scale Regular Insulin (SSRI) | four-time daily in patients with type 2 diabetes mellitus (T2DM) admitted to general medicine and surgery wards. sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards. |
|
|
| Secondary | Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments | Effective Glycemic control is also assessed by number of hypoglycemia events among the patients treated with Basal plus, basal-bolus and SSRI treatments. Hypoglycemia event is defined as blood glucose levels <70 mg/dL. Number of patients with hypoglycemia episodes that are treated with Basal plus, basal-bolus and SSRI treatment regimens during their hospital stay are examined and compared. | Posted | Number | participants | During hospital stay, up to 12 days |
|
|
|
| 3 |
| 133 |
| 18 |
| 133 |
| 16 |
| 133 |
| EG001 | Basal Bolus | glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) | 0 | 144 | 22 | 144 | 13 | 144 |
| EG002 | Sliding Scale Regular Insulin (SSRI) | four-time daily in patients with T2DM admitted to general medicine and surgery wards. sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards. | 0 | 74 | 7 | 74 | 3 | 74 |
|
| wound infections | Infections and infestations | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |