Trial Outcomes & Findings for Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery (NCT NCT00596687)

Results Overview

blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

234 participants

Primary outcome timeframe

hospital stay days 2-10

Results posted on

2014-03-12

Participant Flow

Enrolled patients with a BG 140-400 mg/dL with DM for more than 3 months,aged 18-80 yo, treated with diet alone, any combination of oral antidiabetic agents, or lowdose insulin in 2008-2009. Study was conducted at Grady Memorial Hospital,Emory University Hospitaland the Veterans Administration Medical Center.

Exclusion criteria included hyperglycemia without a known history of diabetes, cardiac surgery, clinically relevant hepatic disease or impaired renal function (serum creatinine ≥3.0 mg/dL), history of diabetic ketoacidosis (20), pregnancy, and any mental condition rendering the subject unable to give informed consent.

Participant milestones

Participant milestones
Measure	Basal Bolus Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.	SSRI Sliding scale regular insulin four-times daily if blood glucose \> 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
Overall Study STARTED	118	116
Overall Study COMPLETED	104	107
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Basal Bolus Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.	SSRI Sliding scale regular insulin four-times daily if blood glucose \> 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
Overall Study < 24 hours of insulin treatment	8	6
Overall Study continuous insulin infusion during TPN	2	1
Overall Study Withdrawal by Subject	3	1
Overall Study cancelled surgery	1	1

Baseline Characteristics

Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basal Bolus n=104 Participants Glargine and rapid-acting mealtime insulin plus supplemental glulisine	SSRI n=107 Participants Sliding scale regular insulin four-times daily.	Total n=211 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=99 Participants	102 Participants n=107 Participants	203 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Age, Continuous	58 years STANDARD_DEVIATION 12 • n=99 Participants	57 years STANDARD_DEVIATION 10 • n=107 Participants	58 years STANDARD_DEVIATION 11 • n=206 Participants
Sex: Female, Male Female	50 Participants n=99 Participants	54 Participants n=107 Participants	104 Participants n=206 Participants
Sex: Female, Male Male	54 Participants n=99 Participants	53 Participants n=107 Participants	107 Participants n=206 Participants
Region of Enrollment United States	104 participants n=99 Participants	107 participants n=107 Participants	211 participants n=206 Participants

PRIMARY outcome

Timeframe: hospital stay days 2-10

blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment

Outcome measures

Outcome measures
Measure	Basal Bolus n=104 Participants Glargine and rapid-acting mealtime insulin plus supplemental glulisine	SSRI n=107 Participants Sliding scale regular insulin four-times daily.
Mean Blood Glucose Concentration	145 mg/dl Standard Deviation 32	172 mg/dl Standard Deviation 46

SECONDARY outcome

Timeframe: hospital stay days 2-10

number of participants in the treatment arms with of hypoglycemic events (\< 70 mg/dl)

Outcome measures

Outcome measures
Measure	Basal Bolus n=104 Participants Glargine and rapid-acting mealtime insulin plus supplemental glulisine	SSRI n=107 Participants Sliding scale regular insulin four-times daily.
# Participants With Hypoglycemic Events	24 participants	5 participants

Adverse Events

Basal Bolus

Serious events: 24 serious events

Other events: 0 other events

Deaths: 0 deaths

SSRI

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Basal Bolus n=104 participants at risk Glargine and rapid-acting mealtime insulin plus supplemental glulisine	SSRI n=107 participants at risk Sliding scale regular insulin four-times daily.
Metabolism and nutrition disorders Hypoglycemia < 70 mg/dl	23.1% 24/104 • Number of events 24 • during hospital days 1-10	4.7% 5/107 • Number of events 5 • during hospital days 1-10

Other adverse events

Adverse event data not reported

Additional Information

Guillermo Umpierrez

Emory Univ SOM

Phone: 4047781665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place