Trial Outcomes & Findings for Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D (NCT NCT04538352)
NCT ID: NCT04538352
Last Updated: 2025-02-18
Results Overview
Mean change in HbA1C ≤ 7.5% from baseline to 26 weeks between the two groups
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
26 weeks
Results posted on
2025-02-18
Participant Flow
Participant milestones
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
40
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D
Baseline characteristics by cohort
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
Total
n=60 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
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
70.1 years
n=5 Participants
|
64.7 years
n=7 Participants
|
68.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
20 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Baseline weight (Kg)
|
103.1 Kg
n=5 Participants
|
111.6 Kg
n=7 Participants
|
104.6 Kg
n=5 Participants
|
|
Baseline HbA1c
|
6.8 % glycated hemoglobin
n=5 Participants
|
6.9 % glycated hemoglobin
n=7 Participants
|
6.8 % glycated hemoglobin
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksMean change in HbA1C ≤ 7.5% from baseline to 26 weeks between the two groups
Outcome measures
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Mean Change in HbA1C ≤ 7.5%
|
-0.5 % glycated hemoglobin
Interval -0.7 to -0.3
|
0 % glycated hemoglobin
Interval -0.3 to 0.3
|
SECONDARY outcome
Timeframe: 26 weeksMean weight change from baseline in body weight at 26 weeks
Outcome measures
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Mean Weight Change
|
-8.6 Kg
Interval -9.6 to -7.6
|
1.4 Kg
Interval 0.0 to 2.8
|
SECONDARY outcome
Timeframe: 26 weeksRecorded for the overall study period
Outcome measures
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Hypoglycemic Episodes
|
.7 frequency of hypoglycemic episodes
Interval 0.3 to 1.5
|
1.4 frequency of hypoglycemic episodes
Interval 0.5 to 3.9
|
SECONDARY outcome
Timeframe: 26 weeksChange from baseline in A1C at week 26
Outcome measures
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Mean Change From Baseline in A1C
|
-.5 actual mean A1C change
Interval -0.7 to -0.3
|
0 actual mean A1C change
Interval -0.3 to 0.3
|
SECONDARY outcome
Timeframe: 26 weeksChange from baseline in diabetes treatment satisfaction at week 26
Outcome measures
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Diabetes Treatment Satisfaction Comparison Between Groups
|
18 units on a scale
Interval 15.0 to 18.0
|
14 units on a scale
Interval 12.3 to 17.5
|
SECONDARY outcome
Timeframe: 26 weeksMean total insulin dose change (U/day) from baseline to week 26
Outcome measures
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 Participants
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 Participants
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
Total Daily Insulin Dose
|
-37.3 units per day of total insulin
Interval -41.0 to -33.6
|
42.5 units per day of total insulin
Interval 35.8 to 49.1
|
Adverse Events
Once-weekly sc Semaglutide Combined With Once-daily Insulin
Serious events: 9 serious events
Other events: 7 other events
Deaths: 0 deaths
MDI Requiring Multiple Daily Injections of Insulin
Serious events: 5 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 participants at risk
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 participants at risk
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • 2 years
|
0.00%
0/20 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
2/40 • Number of events 2 • 2 years
|
5.0%
1/20 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.5%
1/40 • Number of events 1 • 2 years
|
0.00%
0/20 • 2 years
|
|
Nervous system disorders
Syncopal episode
|
5.0%
2/40 • Number of events 2 • 2 years
|
0.00%
0/20 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Number of events 2 • 2 years
|
5.0%
1/20 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • Number of events 1 • 2 years
|
0.00%
0/20 • 2 years
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/40 • 2 years
|
5.0%
1/20 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Chronic Ulcer
|
0.00%
0/40 • 2 years
|
5.0%
1/20 • Number of events 1 • 2 years
|
|
General disorders
Death
|
0.00%
0/40 • 2 years
|
5.0%
1/20 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Once-weekly sc Semaglutide Combined With Once-daily Insulin
n=40 participants at risk
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Semaglutide: Medication for type 2 diabetes management
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
MDI Requiring Multiple Daily Injections of Insulin
n=20 participants at risk
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Insulin Degludec: Medication for type 2 diabetes management
Insulin aspart: Medication for type 2 diabetes management (rapid-acting)
|
|---|---|---|
|
General disorders
Pain
|
17.5%
7/40 • Number of events 7 • 2 years
|
5.0%
1/20 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/40 • 2 years
|
10.0%
2/20 • Number of events 2 • 2 years
|
Additional Information
Research Administrator
The Cleveland Clinic Foundation
Phone: (216) 445-4791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place