Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
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|ClinicalTrials.gov Identifier: NCT02182895|
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : June 1, 2017
Last Update Posted : June 23, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: Saxagliptin||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: 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.
2.5-5 mg daily
No Intervention: Standard therapy group
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.
- Mean Daily Blood Glucose Levels During Hospital [ Time Frame: Hospital days 2-5 ]mean of average daily blood blood glucose for each patient day
- Percentage of Blood Glucose Readings in 70-140 mg/dL Range [ Time Frame: Days 2 to 5 ]Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.
- Dose of Insulin [ Time Frame: Days 2 to 5 ]Average daily amount of insulin used
- Incidence of Hypoglycemia (BG <70 mg/dL) [ Time Frame: Days 2 to 5 ]Number of BG readings <70 mg/dL in each group
- Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) [ Time Frame: Days 2 to 5 ]Proportion of BG readings in the severe hyperglycemic range.
- Variability in Glucose Levels [ Time Frame: Days 2 to 5 ]Mean amplitude of glycemic excursions
- Length of Hospital Stay [ Time Frame: Admission to discharge, an expected average of 5 days ]Number of days in hospital
- Patient Satisfaction [ Time Frame: At the time of discharge or Day 5 ]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.
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|Ages Eligible for Study:||18 Years to 110 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
- Written informed consent.
- Admitted to or expected to require admission to ICU
- Patients with a history of diabetic ketoacidosis or hyperosmolar state
- HbA1c >7.5% at the time of admission or within 3 months before admission
- Insulin requiring before admission
- Unable to take oral food or medications
- Systemic steroid use
- Pregnancy or breastfeeding
- Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
- History of pancreatitis or active gallbladder disease
- End stage renal disease on dialysis
- Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
- Subject unable to give informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182895
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Rajesh K Garg, MD||Brigham and Women's Hospital|
|Responsible Party:||Rajesh K. Garg, Rajesh Garg, MD, Brigham and Women's Hospital|
|Other Study ID Numbers:||
|First Posted:||July 8, 2014 Key Record Dates|
|Results First Posted:||June 1, 2017|
|Last Update Posted:||June 23, 2017|
|Last Verified:||May 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||No plan to share data.|
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