Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02182895
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 31.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Saxagliptin	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Saxagliptin; 2.5-5 mg daily; Other Names: Onglyza DPP4 inhibitor
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.

Outcome Measures

Primary Outcome Measures

1. Mean Daily Blood Glucose Levels During Hospital [Hospital days 2-5]

   mean of average daily blood blood glucose for each patient day

Secondary Outcome Measures

1. 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.

2. Dose of Insulin [Days 2 to 5]

   Average daily amount of insulin used

3. Incidence of Hypoglycemia (BG <70 mg/dL) [Days 2 to 5]

   Number of BG readings <70 mg/dL in each group

4. Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) [Days 2 to 5]

   Proportion of BG readings in the severe hyperglycemic range.

5. Variability in Glucose Levels [Days 2 to 5]

   Mean amplitude of glycemic excursions

6. Length of Hospital Stay [Admission to discharge, an expected average of 5 days]

   Number of days in hospital

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Rajesh K Garg, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajesh K. Garg, Rajesh Garg, MD, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02182895
• Other Study ID Numbers: 2014P001095
• First Posted: Jul 8, 2014
• Last Update Posted: Jun 23, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Saxagliptin; Dipeptidyl-Peptidase IV Inhibitors

Study Results

Participant Flow

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Period Title: Overall Study
STARTED	35	37
COMPLETED	33	33
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Saxagliptin Group	Standard Therapy Group	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	33	33	66
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 21.2%	12 36.4%	19 28.8%
>=65 years	26 78.8%	21 63.6%	47 71.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (10)	67 (10)	68 (10)
Sex: Female, Male (Count of Participants)
Female	20 60.6%	16 48.5%	36 54.5%
Male	13 39.4%	17 51.5%	30 45.5%
Race/Ethnicity, Customized (Count of Participants)
white	26 78.8%	30 90.9%	56 84.8%
Region of Enrollment (participants) [Number]
United States	33 100%	33 100%	66 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	34.5 (12.2)	32.6 (6.5)	33.6 (10)

Outcome Measures

1. Primary Outcome

Title	Mean Daily Blood Glucose Levels During Hospital
Description	mean of average daily blood blood glucose for each patient day
Time Frame	Hospital days 2-5

Outcome Measure Data

Analysis Population Description

Inpatients with diabetes

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Mean (Standard Deviation) [mg/dL]	154.8 (28.2)	156.0 (32.1)

2. Secondary Outcome

Title	Percentage of Blood Glucose Readings in 70-140 mg/dL Range
Description	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

Outcome Measure Data

Analysis Population Description

completed subjects

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Number [% of blood glucose readings]	42	37

3. Secondary Outcome

Title	Dose of Insulin
Description	Average daily amount of insulin used
Time Frame	Days 2 to 5

Outcome Measure Data

Analysis Population Description

completed subjects

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Mean (Standard Deviation) [Units]	2.4 (3.3)	13.3 (12.9)

4. Secondary Outcome

Title	Incidence of Hypoglycemia (BG <70 mg/dL)
Description	Number of BG readings <70 mg/dL in each group
Time Frame	Days 2 to 5

Outcome Measure Data

Analysis Population Description

completed

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Number [number of events]	1	1

5. Secondary Outcome

Title	Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)
Description	Proportion of BG readings in the severe hyperglycemic range.
Time Frame	Days 2 to 5

Outcome Measure Data

Analysis Population Description

completed

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Number [% of blood glucose readings >200]	6	10

6. Secondary Outcome

Title	Variability in Glucose Levels
Description	Mean amplitude of glycemic excursions
Time Frame	Days 2 to 5

Outcome Measure Data

Analysis Population Description

Patients who allowed a CGMS.

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	20	16
Mean (Standard Deviation) [mmol/L]	2.72 (1.60)	3.93 (2.03)

7. Secondary Outcome

Title	Length of Hospital Stay
Description	Number of days in hospital
Time Frame	Admission to discharge, an expected average of 5 days

Outcome Measure Data

Analysis Population Description

completed

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Mean (Standard Deviation) [days]	8.0 (14.6)	6.4 (5.4)

8. Secondary Outcome

Title	Patient Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saxagliptin Group	Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily	No saxagliptin treatment
Measure Participants	33	33
Mean (Standard Deviation) [Score]	70 (12)	75 (11)

Adverse Events

Time Frame	During the study period.
Arm/Group Title	Saxagliptin Group		Standard Therapy Group
Arm/Group Description	saxagliptin 2.5-5 mg daily		No saxagliptin treatment
All Cause Mortality
	Saxagliptin Group		Standard Therapy Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Serious Adverse Events
	Saxagliptin Group		Standard Therapy Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Saxagliptin Group		Standard Therapy Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)		0/33 (0%)
Endocrine disorders
Failure to control hyperglucycemia	2/33 (6.1%)	2	0/33 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.