Trial Outcomes & Findings for Simplified Insulin Protocol Using Lantus in Elderly (NCT NCT01480843)

NCT ID: NCT01480843

Last Updated: 2017-11-08

Results Overview

duration of hypoglycemia measured by continuous glucose monitoring

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 65 participants
• Primary outcome timeframe: baseline, 5 months, 8 months
• Results posted on: 2017-11-08

Participant Flow

Participant milestones

Measure	Glargine We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Overall Study STARTED	65
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Simplified Insulin Protocol Using Lantus in Elderly

Baseline characteristics by cohort

Measure	Glargine n=65 Participants We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	65 Participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 5 months, 8 months

Population: Subject drop outs

duration of hypoglycemia measured by continuous glucose monitoring

Outcome measures

Measure	Glargine n=65 Participants We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Change in Duration of Hypoglycemia Episodes Baseline	277 minutes of hypoglycemia Standard Deviation 252
Change in Duration of Hypoglycemia Episodes 5 months	111 minutes of hypoglycemia Standard Deviation 184
Change in Duration of Hypoglycemia Episodes 8 months	97 minutes of hypoglycemia Standard Deviation 163

PRIMARY outcome

Timeframe: baseline, 5 months, 8 months

Population: Subject drop outs

frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data

Outcome measures

Measure	Glargine n=65 Participants We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months Baseline	4.3 episodes of hypoglycemia Standard Deviation 3.0
Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months 5 months	1.8 episodes of hypoglycemia Standard Deviation 2.0
Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months 8 months	1.5 episodes of hypoglycemia Standard Deviation 2.0

Adverse Events

Glargine

Serious events: 18 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Measure	Glargine n=65 participants at risk We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
General disorders Death	4.6% 3/65 • Number of events 3 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Gastrointestinal disorders Bowel Obstruction	1.5% 1/65 • Number of events 1 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Reproductive system and breast disorders hysterectomy	1.5% 1/65 • Number of events 1 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Vascular disorders Stroke	4.6% 3/65 • Number of events 3 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
General disorders Hospitalization for gout	1.5% 1/65 • Number of events 2 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Cardiac disorders Cardiac stent placed	4.6% 3/65 • Number of events 3 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
General disorders Hospitalization for internal bleeding	3.1% 2/65 • Number of events 3 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Infections and infestations Hospitalization for Cellulitis	1.5% 1/65 • Number of events 1 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
General disorders Hospitalization due to fall	1.5% 1/65 • Number of events 1 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Renal and urinary disorders Hospitalization for Acute renal failure	3.1% 2/65 • Number of events 2 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.

Other adverse events

Measure	Glargine n=65 participants at risk We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
General disorders Prednisone Taper Needed	6.2% 4/65 • Number of events 6 • Adverse Event data was collected during the 8 month time period that the participants were in the trail. Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.

Additional Information

Medha Munshi, MD

Joslin Diabetes Center

Phone: 617-309-4683

Email: medha.munshi@joslin.harvard.edu

Results disclosure agreements

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