Trial Outcomes & Findings for Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin (NCT NCT03455985)

Last Updated: 2024-02-22

Results Overview

We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.

Recruitment status

TERMINATED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

24 weeks

Results posted on

2024-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Discharge Order Set (DOS) Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Overall Study STARTED	82	76
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	38	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Discharge Order Set (DOS) n=82 Participants Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) n=76 Participants Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.	Total n=158 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	67 Participants n=7 Participants	139 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	52.0 years STANDARD_DEVIATION 10.1 • n=5 Participants	51.4 years STANDARD_DEVIATION 10.5 • n=7 Participants	51.7 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	75 Participants n=7 Participants	155 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	76 participants n=7 Participants	158 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Data were collected at study visits and extracted from the electronic medical records.

Outcome measures

Outcome measures
Measure	Discharge Order Set (DOS) n=44 Participants Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) n=45 Participants Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Change in HbA1c From Baseline to 24 Weeks	-2.1 percentage of glycosylated hemoglobin Standard Error 0.3	-1.0 percentage of glycosylated hemoglobin Standard Error 0.3

SECONDARY outcome

Timeframe: 12 weeks

Population: HbA1c was obtained from study visits as well as from the electronic medical record.

Outcome measures

Outcome measures
Measure	Discharge Order Set (DOS) n=54 Participants Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) n=54 Participants Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Change in HbA1c From Baseline to 12 Weeks	-2.0 percentage of glycosylated hemoglobin Standard Error 0.3	-1.4 percentage of glycosylated hemoglobin Standard Error 0.3

SECONDARY outcome

Timeframe: 24 weeks

Population: The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.

proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.

Outcome measures

Outcome measures
Measure	Discharge Order Set (DOS) n=32 Participants Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) n=30 Participants Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Proportion Using Insulin Glargine U300 at 24 Weeks	25 Participants	25 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Data were collected from study visits from participants who were fasting.

We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model. reported measure differs from original plan due to lack of fasting glucose in hospitalized patients.

Outcome measures

Outcome measures
Measure	Discharge Order Set (DOS) n=20 Participants Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) n=21 Participants Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Fasting Glucose	152.5 mg/dl Interval 127.3 to 247.3	209 mg/dl Interval 129.5 to 234.0

Adverse Events

Discharge Order Set (DOS)

Serious events: 30 serious events

Other events: 0 other events

Deaths: 1 deaths

Enhanced Standard Care (ESC)

Serious events: 34 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Dungan

The Ohio State University

Phone: 6146853333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Discharge Order Set (DOS) n=82 participants at risk Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.	Enhanced Standard Care (ESC) n=76 participants at risk Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Endocrine disorders Severe hypoglycemia	6.1% 5/82 • Number of events 5 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	10.5% 8/76 • Number of events 10 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Endocrine disorders Hyperglycemia	3.7% 3/82 • Number of events 3 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	2.6% 2/76 • Number of events 4 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Endocrine disorders Diabetic ketoacidosis	2.4% 2/82 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Renal and urinary disorders Acute kidney injury	2.4% 2/82 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	2.6% 2/76 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Renal and urinary disorders hyperkalemia	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Nervous system disorders Transient Ischemic Attack	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Musculoskeletal and connective tissue disorders Lumbar degenerative disc disease	2.4% 2/82 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Respiratory, thoracic and mediastinal disorders sarcoidosis	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Cardiac disorders chest pain	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	2.6% 2/76 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Skin and subcutaneous tissue disorders wound infection	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Skin and subcutaneous tissue disorders foot ulcer	2.4% 2/82 • Number of events 4 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Vascular disorders lower extremity edema	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Cardiac disorders arrhythmia	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Gastrointestinal disorders clostridium dificile collitis	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Cardiac disorders hypertensive urgency	1.2% 1/82 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Musculoskeletal and connective tissue disorders neck pain	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Nervous system disorders cerebrovascular accident	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	2.6% 2/76 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Respiratory, thoracic and mediastinal disorders pneumonia	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Gastrointestinal disorders gastroenteritis	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Musculoskeletal and connective tissue disorders cervical stenosis	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Ear and labyrinth disorders vertigo	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Cardiac disorders heart failure	2.4% 2/82 • Number of events 2 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	6.6% 5/76 • Number of events 6 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Infections and infestations dental abscess	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Eye disorders dacroadenitis	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
General disorders fall	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Cardiac disorders angina	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Renal and urinary disorders cystitis	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Surgical and medical procedures hernia	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Skin and subcutaneous tissue disorders cellulitis	0.00% 0/82 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	1.3% 1/76 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding
Respiratory, thoracic and mediastinal disorders tracheobronchitis	1.2% 1/82 • Number of events 1 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding	0.00% 0/76 • 24 weeks Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply: DEFINITIONS Serious adverse event (SAE): any untoward medical occurrence including: * Results in death, hospitalization, disability, congenital anomaly * Is life threatening, * Is a medically important event or reaction. Related Adverse Event, i.e. Adverse Drug Reaction Unexpected Adverse Event New Safety finding