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The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.
The current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. It is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital.
The study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. The study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)
The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin group | Experimental | DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime. |
|
| Standard therapy group | No Intervention | Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 2.5-5 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose Levels During Hospital | mean of average daily blood blood glucose for each patient day | Hospital days 2-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Blood Glucose Readings in 70-140 mg/dL Range | Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings. | Days 2 to 5 |
| Dose of Insulin | Average daily amount of insulin used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh K Garg, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28405346 | Derived | Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017. |
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No plan to share data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin Group | saxagliptin 2.5-5 mg daily |
| FG001 | Standard Therapy Group | No saxagliptin treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin Group | DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime. Saxagliptin: 2.5-5 mg daily |
| BG001 | Standard Therapy Group |
| 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 Daily Blood Glucose Levels During Hospital | mean of average daily blood blood glucose for each patient day | Inpatients with diabetes | Posted | Mean | Standard Deviation | mg/dL | Hospital days 2-5 |
|
|
During the study period.
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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 | Saxagliptin Group | saxagliptin 2.5-5 mg daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure to control hyperglucycemia | Endocrine disorders | Systematic Assessment | Study drug stopped |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajesh Garg, MD | Brigham and Women's Hospital | 617-732-5584 | rgarg@partners.org |
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| ID | Term |
|---|---|
| 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 |
|---|---|
| C502994 | saxagliptin |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Days 2 to 5 |
| Incidence of Hypoglycemia (BG <70 mg/dL) | Number of BG readings <70 mg/dL in each group | Days 2 to 5 |
| Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) | Proportion of BG readings in the severe hyperglycemic range. | Days 2 to 5 |
| Variability in Glucose Levels | Mean amplitude of glycemic excursions | Days 2 to 5 |
| Length of Hospital Stay | Number of days in hospital | Admission to discharge, an expected average of 5 days |
| Patient Satisfaction | Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction. | At the time of discharge or Day 5 |
Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Percentage of Blood Glucose Readings in 70-140 mg/dL Range | Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings. | completed subjects | Posted | Number | % of blood glucose readings | Days 2 to 5 |
|
|
|
| Secondary | Dose of Insulin | Average daily amount of insulin used | completed subjects | Posted | Mean | Standard Deviation | Units | Days 2 to 5 |
|
|
|
| Secondary | Incidence of Hypoglycemia (BG <70 mg/dL) | Number of BG readings <70 mg/dL in each group | completed | Posted | Number | number of events | Days 2 to 5 |
|
|
|
| Secondary | Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) | Proportion of BG readings in the severe hyperglycemic range. | completed | Posted | Number | % of blood glucose readings >200 | Days 2 to 5 |
|
|
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| Secondary | Variability in Glucose Levels | Mean amplitude of glycemic excursions | Patients who allowed a CGMS. | Posted | Mean | Standard Deviation | mmol/L | Days 2 to 5 |
|
|
|
| Secondary | Length of Hospital Stay | Number of days in hospital | completed | Posted | Mean | Standard Deviation | days | Admission to discharge, an expected average of 5 days |
|
|
|
| Secondary | Patient Satisfaction | Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction. | Posted | Mean | Standard Deviation | Score | At the time of discharge or Day 5 |
|
|
|
| 33 |
| 0 |
| 33 |
| 2 |
| 33 |
| EG001 | Standard Therapy Group | No saxagliptin treatment | 0 | 33 | 0 | 33 | 0 | 33 |
|
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| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |