Trial Outcomes & Findings for Diabetes in the Elderly: Prospective Study (NCT NCT01131052)

NCT ID: NCT01131052

Last Updated: 2014-12-31

Results Overview

Mean weekly blood glucose concentration less than 70 mg/dL at 3 months

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 150 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2014-12-31

Participant Flow

Recruitment took place at Emory University-Wesley Woods Campus between March 2011 through December 2013.

Participant milestones

Measure	BASAL PLUS Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Overall Study STARTED	75	75
Overall Study COMPLETED	75	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes in the Elderly: Prospective Study

Baseline characteristics by cohort

Measure	BASAL PLUS n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed	Total n=150 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	73 Participants n=5 Participants	72 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	47 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Mean weekly blood glucose concentration less than 70 mg/dL at 3 months

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL	28 percentage of participants	31 percentage of participants

PRIMARY outcome

Timeframe: 3 months

Mean weekly blood glucose concentration less than 40 mg/dL at 3 months

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL	0 percentage of participants	1 percentage of participants

PRIMARY outcome

Timeframe: 3 months

Mean weekly blood glucose concentration at 3 months

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Mean of Weekly Fasting Blood Glucose Concentration	130 mg/dL Standard Deviation 26	123 mg/dL Standard Deviation 23

SECONDARY outcome

Timeframe: Baseline

Mean blood glucose concentration at baseline

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Mean Blood Glucose Concentration	198.2 mg/dL Standard Deviation 39.7	191.8 mg/dL Standard Deviation 35.2

SECONDARY outcome

Timeframe: Baseline

Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Mean of Glycosylated Hemoglobin (hbA1c)	6.8 percent of glycosylated hemoglobin Standard Deviation 0.8	6.5 percent of glycosylated hemoglobin Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline

Mean of daily blood glucose concentration at baseline

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Mean of Daily Blood Glucose Concentration	163.0 mg/dL Standard Deviation 29.4	137.7 mg/dL Standard Deviation 27.4

SECONDARY outcome

Timeframe: 3 months

Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Mean of Glycosylated Hemoglobin (hbA1c)	7.0 percent of glycosylated hemoglobin Standard Deviation 1	6.3 percent of glycosylated hemoglobin Standard Deviation 1.0

SECONDARY outcome

Timeframe: 6 months

Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.

Outcome measures

Measure	Basal Plus n=75 Participants Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 Participants Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Mean of Glycosylated Hemoglobin (hbA1c)	6.7 percent of glycosylated hemoglobin Standard Deviation 1.1	6.3 percent of glycosylated hemoglobin Standard Deviation 0.7

Adverse Events

BASAL PLUS

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Sliding Scale Regular Insulin (SSRI)

Serious events: 12 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	BASAL PLUS n=75 participants at risk Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 participants at risk Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Cardiac disorders Death	1.3% 1/75	0.00% 0/75
Cardiac disorders ER visit	2.7% 2/75	1.3% 1/75
Cardiac disorders Hospitalization	8.0% 6/75	14.7% 11/75

Other adverse events

Measure	BASAL PLUS n=75 participants at risk Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed	Sliding Scale Regular Insulin (SSRI) n=75 participants at risk Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Infections and infestations Infection	14.7% 11/75	21.3% 16/75
Renal and urinary disorders ARF	2.7% 2/75	8.0% 6/75
Cardiac disorders CV	5.3% 4/75	1.3% 1/75

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: geumpie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place