Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGSaxagliptin
2.5-5 mg daily
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Daily Blood Glucose Levels During Hospital | Hospital days 2-5 | mean of average daily blood blood glucose for each patient day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Insulin | Days 2 to 5 | Average daily amount of insulin used |
| Incidence of Hypoglycemia (BG <70 mg/dL) | Days 2 to 5 | Number of BG readings \<70 mg/dL in each group |
| Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) | Days 2 to 5 | Proportion of BG readings in the severe hyperglycemic range. |
| Percentage of Blood Glucose Readings in 70-140 mg/dL Range | Days 2 to 5 | Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings. |
| Length of Hospital Stay | Admission to discharge, an expected average of 5 days | Number of days in hospital |
| Patient Satisfaction | 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. |
| Variability in Glucose Levels | Days 2 to 5 | Mean amplitude of glycemic excursions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| 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. | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged from hospital within 24 hours | 2 | 4 |
Baseline characteristics
| Characteristic | Saxagliptin Group | Standard Therapy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 21 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 12 Participants | 19 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 10 | 68 years STANDARD_DEVIATION 10 |
| BMI | 34.5 kg/m^2 STANDARD_DEVIATION 12.2 | 32.6 kg/m^2 STANDARD_DEVIATION 6.5 | 33.6 kg/m^2 STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized white | 26 Participants | 30 Participants | 56 Participants |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 20 Participants | 16 Participants | 36 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 2 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Mean Daily Blood Glucose Levels During Hospital
mean of average daily blood blood glucose for each patient day
Time frame: Hospital days 2-5
Population: Inpatients with diabetes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin Group | Mean Daily Blood Glucose Levels During Hospital | 154.8 mg/dL | Standard Deviation 28.2 |
| Standard Therapy Group | Mean Daily Blood Glucose Levels During Hospital | 156.0 mg/dL | Standard Deviation 32.1 |
Secondary
Dose of Insulin
Average daily amount of insulin used
Time frame: Days 2 to 5
Population: completed subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin Group | Dose of Insulin | 2.4 Units | Standard Deviation 3.3 |
| Standard Therapy Group | Dose of Insulin | 13.3 Units | Standard Deviation 12.9 |
Secondary
Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)
Proportion of BG readings in the severe hyperglycemic range.
Time frame: Days 2 to 5
Population: completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin Group | Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) | 6 % of blood glucose readings >200 |
| Standard Therapy Group | Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) | 10 % of blood glucose readings >200 |
Secondary
Incidence of Hypoglycemia (BG <70 mg/dL)
Number of BG readings \<70 mg/dL in each group
Time frame: Days 2 to 5
Population: completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin Group | Incidence of Hypoglycemia (BG <70 mg/dL) | 1 number of events |
| Standard Therapy Group | Incidence of Hypoglycemia (BG <70 mg/dL) | 1 number of events |
Secondary
Length of Hospital Stay
Number of days in hospital
Time frame: Admission to discharge, an expected average of 5 days
Population: completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin Group | Length of Hospital Stay | 8.0 days | Standard Deviation 14.6 |
| Standard Therapy Group | Length of Hospital Stay | 6.4 days | Standard Deviation 5.4 |
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.
Time frame: At the time of discharge or Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin Group | Patient Satisfaction | 70 Score | Standard Deviation 12 |
| Standard Therapy Group | Patient Satisfaction | 75 Score | Standard Deviation 11 |
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.
Time frame: Days 2 to 5
Population: completed subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin Group | Percentage of Blood Glucose Readings in 70-140 mg/dL Range | 42 % of blood glucose readings |
| Standard Therapy Group | Percentage of Blood Glucose Readings in 70-140 mg/dL Range | 37 % of blood glucose readings |
Secondary
Variability in Glucose Levels
Mean amplitude of glycemic excursions
Time frame: Days 2 to 5
Population: Patients who allowed a CGMS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin Group | Variability in Glucose Levels | 2.72 mmol/L | Standard Deviation 1.6 |
| Standard Therapy Group | Variability in Glucose Levels | 3.93 mmol/L | Standard Deviation 2.03 |