Trial Outcomes & Findings for Glycemia in Diabetic Elders Trial (NCT NCT02029846)
NCT ID: NCT02029846
Last Updated: 2023-04-18
Results Overview
Data not analyzed due to n=1 each arm.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
6 months
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
Standard Treatment
A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only
|
Incretin-based Treatment
A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Standard Treatment
A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only
|
Incretin-based Treatment
A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs
|
|---|---|---|
|
Overall Study
n=1 each arm
|
1
|
1
|
Baseline Characteristics
Glycemia in Diabetic Elders Trial
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=1 Participants
A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only
|
Incretin-based Treatment
n=1 Participants
A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs
|
Total
n=2 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
78 years
n=99 Participants
|
67 years
n=107 Participants
|
72.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed due to n=1 each arm.
Data not analyzed due to n=1 each arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed due to n=1 each arm.
Data not analyzed due to n=1 each arm.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Data not analyzed due to n=1 each arm
Data not analyzed due to n=1 each arm
Outcome measures
Outcome data not reported
Adverse Events
Standard Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Incretin-based Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place