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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The study is a multicenter, prospective, open-label, randomized pilot study to investigate the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2 diabetes (T2D) in general medicine and surgery patients.
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose, but has not been tested in the hospital. It is not known if sitagliptin is as effective in controlling blood sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine) injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar in hospitalized patients with diabetes.
In this pilot study, patients with known history of diabetes treated with diet and/or oral anti-diabetics or with low total daily dose insulin therapy (<0.4 unit/kg/day) will be randomized to receive sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily (group 2), or basal bolus regimen with glargine once daily and lispro insulin before meals (group 3). If needed, patients in the 3 treatment groups will receive correction doses of rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG > 140 mg/dl) per sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone or in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in glycemic control and in a lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before meals.
A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will be recruited at Grady Memorial Hospital and Emory University Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin + SSI prn | Experimental | Sitagliptin once daily plus supplemental doses of lispro if needed using sliding scale insulin (SSI). 100 mg/day (at any time of day) for patients with GFR 50-100 ml/min and 50 mg/day for patients with GFR 30-50 ml/min |
|
| Sitagliptin and glargine+ SSI | Experimental | Sitagliptin 50-100 mg per oral once a day and SubCutaneous (SQ) glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI). 100 mg/day (at any time of day) for patients with glomerular filtration rate (GFR) 50-100 ml/min and 50 mg/day for patients with GFR 30-50 ml/min |
|
| Glargine and Lispro + SSI | Active Comparator | Glargine once daily and lispro before meals supplemental insulin lispro as needed for elevated blood glucose using sliding scale insulin (SSI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 50-100mg po once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy | The primary outcome of the study is to determine differences in glycemic control as measured by mean BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with type 2 diabetes mellitus, at the time of admission to the blood glucose levels 24hrs after the therapy | Admission and after 1st day of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Hypoglycemic Events Among the Treatment Groups | Hypoglycemia is defined as blood glucose (BG) reading <70 mg/dl. The number of hypoglycemia events during hospitalization are recorded and compared among the different groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter | during hospitalization,up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University 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 |
|---|---|---|---|
| 23877988 | Result | Umpierrez GE, Gianchandani R, Smiley D, Jacobs S, Wesorick DH, Newton C, Farrokhi F, Peng L, Reyes D, Lathkar-Pradhan S, Pasquel F. Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study. Diabetes Care. 2013 Nov;36(11):3430-5. doi: 10.2337/dc13-0277. Epub 2013 Jul 22. |
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Patients were included if they had Type 2 Diabetes with a BG 140-400 mg/dL and were treated at home with diet, oral antidiabetics, or low-dose insulin. 8 patients were excluded from further analysis because they received <24 h of insulin treatment, were transferred to the ICU, or received corticosteroid therapy.
90 patients admitted to general medicine and surgery services in 2012 were enrolled in this pilot study. This study was conducted at Grady Memorial Hospital (Atlanta, GA), Emory University Hospital, and University of Michigan Health System.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin + SSI Prn | Sitagliptin once daily plus supplemental doses of lispro if needed. |
| FG001 | Sitagliptin and Glargine+ SSI | Sitagliptin 50-100 mg po once a day and Subcutaneous glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI) |
| FG002 | Glargine and Lispro + SSI | Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin + SSI Prn | Sitagliptin once daily plus supplemental doses of lispro if needed. |
| BG001 | Sitagliptin and Glargine + SSI | Sitagliptin 50-100 mg po once a day and subcutaneous glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy | The primary outcome of the study is to determine differences in glycemic control as measured by mean BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with type 2 diabetes mellitus, at the time of admission to the blood glucose levels 24hrs after the therapy | Posted | Mean | Standard Deviation | mg/dl | Admission and after 1st day of therapy |
|
The time frame includes the number of days the subjects stayed in the hospital, the maximum was up to 10 days.
Please note that 8 patients did not receive study medication because they either withdrew or were discharged prior to receiving study medication; thus the number of participants at risk is 90-8=82 (as stated).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin + SSI Prn | Sitagliptin once daily plus supplemental doses of lispro if needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioedema | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Systematic Assessment | Low blood sugar (hypoglycemia) defined as blood glucose less than 70 mg/dl can occur in 10-30% (10 to 30 patients out of one hundred) in hospital patients treated with insulin. |
Study recruited a relatively small number of patients and excluded a large number of patients, which included those admitted to the ICU. Study was not powered to determine differences in hospital complications across the three groups
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez, MD | EUSOM | 4047781665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| glargine | Drug | glargine once daily |
|
|
| lispro | Drug | lispro before meals |
|
|
| Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups | severe hypoglycemic episodes are defined as blood glucose levels <40 mg/dl. The number of patients with these events during the 5 days of hospitalization are recorded and compared. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter. | during hospitalization,up to 5 days |
| Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups | Mean daily blood glucose levels are measured to assess the treatment Failures. For study purpose Treatment failure was defined as having three or more consecutive Blood Glucose (BG) readings > 240 mg/dL or a mean daily BG >240 mg/dL after the 1st day of treatment. Number of patients with a mean daily BG > 240 mg/dL after the 1st day of treatment are recorded and compared among the treatment groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter. | during hospitalization,up to 10 days |
| Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups | The total insulin includes total glargine insulin (units/day) and total lispro insulin (units/day) given to subjects for maintaining blood glucose levels during hospitalization in different groups. The goal of therapy was to maintain a fasting and premeal glucose concentration between 100 and 140 mg/dL. The doses of insulin were adjusted daily according to protocol. The mean amount is calculated among the different groups and compared. | during hospitalization, up to 10 days |
| Mean Length of Stay in Days in the Hospital Among Different Groups | The duration of stay in days in the hospital between the three groups is calculated and mean number of days is measured. | during hospitalization, up to 10 days |
| Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization | Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline). The total daily dose of insulin and sitagliptin will be adjusted as per serum creatinine concentration. The total daily insulin dose will be reduced to 0.3 unit/kg in patients with creatinine >1.7 mg/dl. The dose of sitagliptin will be reduced to 50 mg/day in patients with creatinine clearance between 30-50 ml/min (approximate serum creatinine levels >1.7 and ≤3.0 mg/dl for men and >1.5 and ≤2.5 mg/dl for women). | during hospitalization, up to 10 days |
| Number of Deaths Among the Subjects in Different Groups | Mortality is defined as death occurring during admission among the participants. The number of deaths in each assigned group is calculated. | during hospitalization, up to 10 days |
| Percent of Blood Glucose Readings Within Target Range Between 70 and 140 mg/dL Among the Three Groups After 24 Hrs of Randomized Treatment | The blood glucose within target range is defined as the levels between 70 mg/dL and 140 mg/dL. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter (ACCUCHECK; Roche, Indianapolis, IN). In addition, BG was measured at any time if a patient experienced symptoms of hypoglycemia or if requested by the treating physician. the percentage of the readings are calculated and compared | during hospitalization, up to 10 days |
| Atlanta |
| Georgia |
| 30324 |
| United States |
| BG002 | Glargine and Lispro + SSI | Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sitagliptin 50-100 mg po once a day and subcutaneous glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)
| OG002 | Glargine and Lispro + SSI | Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI) |
|
|
| Secondary | Number of Patients With Hypoglycemic Events Among the Treatment Groups | Hypoglycemia is defined as blood glucose (BG) reading <70 mg/dl. The number of hypoglycemia events during hospitalization are recorded and compared among the different groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter | Posted | Count of Participants | Participants | during hospitalization,up to 10 days |
|
|
|
| Secondary | Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups | severe hypoglycemic episodes are defined as blood glucose levels <40 mg/dl. The number of patients with these events during the 5 days of hospitalization are recorded and compared. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter. | Posted | Count of Participants | Participants | during hospitalization,up to 5 days |
|
|
|
| Secondary | Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups | Mean daily blood glucose levels are measured to assess the treatment Failures. For study purpose Treatment failure was defined as having three or more consecutive Blood Glucose (BG) readings > 240 mg/dL or a mean daily BG >240 mg/dL after the 1st day of treatment. Number of patients with a mean daily BG > 240 mg/dL after the 1st day of treatment are recorded and compared among the treatment groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter. | Posted | Count of Participants | Participants | during hospitalization,up to 10 days |
|
|
|
| Secondary | Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups | The total insulin includes total glargine insulin (units/day) and total lispro insulin (units/day) given to subjects for maintaining blood glucose levels during hospitalization in different groups. The goal of therapy was to maintain a fasting and premeal glucose concentration between 100 and 140 mg/dL. The doses of insulin were adjusted daily according to protocol. The mean amount is calculated among the different groups and compared. | Posted | Mean | Standard Deviation | units/day | during hospitalization, up to 10 days |
|
|
|
| Secondary | Mean Length of Stay in Days in the Hospital Among Different Groups | The duration of stay in days in the hospital between the three groups is calculated and mean number of days is measured. | Posted | Mean | Standard Deviation | days | during hospitalization, up to 10 days |
|
|
|
| Secondary | Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization | Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline). The total daily dose of insulin and sitagliptin will be adjusted as per serum creatinine concentration. The total daily insulin dose will be reduced to 0.3 unit/kg in patients with creatinine >1.7 mg/dl. The dose of sitagliptin will be reduced to 50 mg/day in patients with creatinine clearance between 30-50 ml/min (approximate serum creatinine levels >1.7 and ≤3.0 mg/dl for men and >1.5 and ≤2.5 mg/dl for women). | Posted | Count of Participants | Participants | during hospitalization, up to 10 days |
|
|
|
| Secondary | Number of Deaths Among the Subjects in Different Groups | Mortality is defined as death occurring during admission among the participants. The number of deaths in each assigned group is calculated. | Posted | Count of Participants | Participants | during hospitalization, up to 10 days |
|
|
|
| Secondary | Percent of Blood Glucose Readings Within Target Range Between 70 and 140 mg/dL Among the Three Groups After 24 Hrs of Randomized Treatment | The blood glucose within target range is defined as the levels between 70 mg/dL and 140 mg/dL. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter (ACCUCHECK; Roche, Indianapolis, IN). In addition, BG was measured at any time if a patient experienced symptoms of hypoglycemia or if requested by the treating physician. the percentage of the readings are calculated and compared | Posted | Mean | Standard Deviation | percentage of blood glucose readings | during hospitalization, up to 10 days |
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| 8 |
| 27 |
| EG001 | Sitagliptin and Glargine + SSI | Sitagliptin 50-100 mg po once a day and SQ glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI) | 0 | 29 | 0 | 29 | 7 | 29 |
| EG002 | Glargine and Lispro + SSI | Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blo0d glucose using sliding scale Insulin (SSI) | 0 | 26 | 0 | 26 | 8 | 26 |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment | Persistent Hyperglycemia high blood glucose levels greater than 240 mg/dl |
|
| Pressure Ulcer/Skin Ulcer | General disorders | Non-systematic Assessment |
|
| Urinary Tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wound infection | General disorders | Non-systematic Assessment |
|
| Systematic Infection | General disorders | Non-systematic Assessment |
|
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| D011719 |
| Pyrazines |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |