Trial Outcomes & Findings for Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy? (NCT NCT02846233)
NCT ID: NCT02846233
Last Updated: 2020-11-10
Results Overview
change in A1c (%) from baseline to end of study at 16 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
16 weeks (from baseline to end of study at 16 weeks)
Results posted on
2020-11-10
Participant Flow
Participant milestones
| Measure |
Treatment Group
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
Baseline characteristics by cohort
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
51.8 years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
55.65 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanics
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)change in A1c (%) from baseline to end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Change in A1c at the End of Study Period
|
-2.38 % change of A1c
Interval -2.93 to -1.83
|
-0.83 % change of A1c
Interval -2.05 to 0.4
|
SECONDARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)change (in pounds) from baseline to the end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in Weight
|
-16.38 pounds
Interval -25.63 to -7.13
|
-0.1 pounds
Interval -1.34 to 1.14
|
SECONDARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)change (mmHg) of systolic BP from baseline to the end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in Blood Pressure
|
-16 mmHg
Interval -33.37 to 1.37
|
15 mmHg
Interval 2.56 to 27.44
|
SECONDARY outcome
Timeframe: 16 weekschange (beats/min) from baseline to the end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in Heart Rate
|
4.3 beats per min
Interval -1.05 to 9.65
|
5.13 beats per min
Interval -3.93 to 14.18
|
SECONDARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)change (mg/dL) from baseline to the end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in LDL
|
-15.7 mg/dL
Interval -30.29 to -1.11
|
21 mg/dL
Interval -9.9 to 51.9
|
SECONDARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)change (mg/dL) from baseline to the end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in Total Cholesterol
|
-18.5 mg/dL
Interval -35.79 to -1.21
|
18.38 mg/dL
Interval -22.38 to 59.13
|
SECONDARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)change (mg/dL) from baseline to the end of study at 16 weeks
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in Serum Creatinine
|
0.04 mg/dL
Interval -0.08 to 0.16
|
0.04 mg/dL
Interval -0.04 to 0.11
|
SECONDARY outcome
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)Patient satisfaction with treatment in both groups will be measured by the validated the Diabetes Medications Satisfaction Tool (DM-SAT). Response options range from 0="not at all satisfied" to 10="extremely satisfied" and a total score is calculated ranging from 0 to 100, with higher scores indicating more diabetes medication satisfaction.
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=8 Participants
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Changes in Treatment Satisfaction Scores (DM-SAT Total Score)
|
45.3 score on a scale
Interval 28.19 to 62.41
|
4.63 score on a scale
Interval -0.83 to 10.08
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=12 participants at risk
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin.
basal insulin: The participant will continue with the basal insulin.
SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin.
Metformin: The participant will continue with metformin.
|
Control Group
n=10 participants at risk
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
|
|---|---|---|
|
Metabolism and nutrition disorders
Mild hypoglycemia
|
8.3%
1/12 • Number of events 1 • 12 months
|
20.0%
2/10 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • Number of events 9 • 12 months
|
0.00%
0/10 • 12 months
|
|
Metabolism and nutrition disorders
Severe hypoglycemia
|
0.00%
0/12 • 12 months
|
10.0%
1/10 • Number of events 1 • 12 months
|
Additional Information
SOE NAING
University of California San Francisco, Fresno Medical Education Program
Phone: 5593239236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place