Trial Outcomes & Findings for Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients (NCT NCT02324842)
NCT ID: NCT02324842
Last Updated: 2019-12-18
Results Overview
Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Approximately 4 months
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Canagliflozin
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Canagliflozin
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Canagliflozin
n=14 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=14 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=13 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
13 Participants
n=13 Participants
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
7 Participants
n=13 Participants
|
17 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
6 Participants
n=13 Participants
|
24 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
13 participants
n=13 Participants
|
41 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Approximately 4 monthsPrimary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
HbA1c at 4 Months
|
8.2 percentage glycated hemoglobin
Standard Deviation 0.3
|
8.4 percentage glycated hemoglobin
Standard Deviation 0.3
|
8.1 percentage glycated hemoglobin
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline to Approximately 4 monthsValues will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Fasting Plasma Glucose (FPG) at 4 Months
|
174 mg/dl
Standard Deviation 12
|
177 mg/dl
Standard Deviation 10
|
180 mg/dl
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Approximately 4 monthsA measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Body Mass Index (BMI) at 4 Months
|
34.8 kg/m2
Standard Deviation 1.7
|
35.1 kg/m2
Standard Deviation 1.1
|
34.8 kg/m2
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to Approximately 4 monthsValues will be presented as the mean + SD. The Matsuda Index is a novel assessment of insulin sensitivity that is simple to calculate and provides a reasonable approximation of whole-body insulin sensitivity from the OGTT. The index is calculated from plasma glucose (mg/dl) and insulin (mIU/l) concentrations in both fasting state and post-OGTT. The index value obtained is compared to normal physiologic values to assess insulin sensitivity or resistance. The higher the number, the more insulin sensitive and the lower the number the more insulin resistant the subjects are. Insulin secretion will be measured from plasma C-peptide concentration during the OGTT and the Mari Model will be used to measure beta cell glucose sensitivity
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)
|
0.8 index value
Standard Deviation 0.4
|
-0.5 index value
Standard Deviation 0.4
|
0.1 index value
Standard Deviation 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Approximately 4 monthsValues will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Change in Free Plasma Insulin at the End of the Study From Baseline Value
|
-2 mg/ml
Standard Deviation 2
|
2 mg/ml
Standard Deviation 2
|
0.7 mg/ml
Standard Deviation 1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 4 monthsValues will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline
|
12 mg/ml
Standard Deviation 6
|
-7 mg/ml
Standard Deviation 5
|
-5 mg/ml
Standard Deviation 5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 4 monthsValues will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. The difference between baseline and study end will represent the change in body weight due to change in hepatic, visceral and abdominal subcutaneous fat.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Change in Total Body Weight at Study End Compared to Baseline
|
-3.5 kg
Standard Deviation 0.5
|
-1.9 kg
Standard Deviation .8
|
-6.0 kg
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 4 monthsValues will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.
Outcome measures
| Measure |
Canagliflozin
n=15 Participants
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 Participants
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 Participants
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Change in 24-hour Blood Pressure at Study End Compared to Baseline.
|
-5.2 mmHg
Standard Deviation 2.2
|
5.1 mmHg
Standard Deviation 3.8
|
-14.1 mmHg
Standard Deviation 3.0
|
Adverse Events
Canagliflozin
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Liraglutide
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Canagliflozin Plus Liraglutide
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canagliflozin
n=15 participants at risk
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 participants at risk
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 participants at risk
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
General disorders
Dehydration/Hyperkalemia
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
Other adverse events
| Measure |
Canagliflozin
n=15 participants at risk
canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
|
Liraglutide
n=15 participants at risk
liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
Canagliflozin Plus Liraglutide
n=15 participants at risk
canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects
Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
60.0%
9/15 • Number of events 11 • Adverse Events were reported from Baseline to 4 months
|
53.3%
8/15 • Number of events 12 • Adverse Events were reported from Baseline to 4 months
|
|
Gastrointestinal disorders
Dry Mouth
|
26.7%
4/15 • Number of events 5 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
40.0%
6/15 • Number of events 7 • Adverse Events were reported from Baseline to 4 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
46.7%
7/15 • Number of events 11 • Adverse Events were reported from Baseline to 4 months
|
26.7%
4/15 • Number of events 4 • Adverse Events were reported from Baseline to 4 months
|
|
Gastrointestinal disorders
Decreased Appetite
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
13.3%
2/15 • Number of events 2 • Adverse Events were reported from Baseline to 4 months
|
|
Gastrointestinal disorders
Gastrointestinal Reflux/Indigestion
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
26.7%
4/15 • Number of events 7 • Adverse Events were reported from Baseline to 4 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
33.3%
5/15 • Number of events 5 • Adverse Events were reported from Baseline to 4 months
|
33.3%
5/15 • Number of events 6 • Adverse Events were reported from Baseline to 4 months
|
|
Renal and urinary disorders
Urinary Frequency increased
|
86.7%
13/15 • Number of events 15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
|
Nervous system disorders
Light-headedness/Dizziness
|
26.7%
4/15 • Number of events 5 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
13.3%
2/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
|
Nervous system disorders
Anxiety
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
13.3%
2/15 • Number of events 2 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
|
Skin and subcutaneous tissue disorders
Redness at Injection Site
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
13.3%
2/15 • Number of events 2 • Adverse Events were reported from Baseline to 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Cramps
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough and nasal congestion
|
13.3%
2/15 • Number of events 2 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
6.7%
1/15 • Number of events 1 • Adverse Events were reported from Baseline to 4 months
|
|
Metabolism and nutrition disorders
Symptomatic Hypoglycemia
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
|
Reproductive system and breast disorders
Vaginal Candidiasis
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
20.0%
3/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
|
Reproductive system and breast disorders
Vaginal itching or foreskin pain
|
13.3%
2/15 • Number of events 3 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
0.00%
0/15 • Adverse Events were reported from Baseline to 4 months
|
Additional Information
Eugenio Cersosimo, MD
University of Texas Health San Antonio
Phone: 210-358-7220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place