Trial Outcomes & Findings for Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition (NCT NCT04542291)
NCT ID: NCT04542291
Last Updated: 2023-02-14
Results Overview
* Adverse events will be graded with CTCAE v. 5.0. * Related indicates adverse events possibly, probably, or definitely related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From start of treatment through 30 days after treatment (estimated to be 3 months)
Results posted on
2023-02-14
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Dapagliflozin
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=15 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Age, Continuous
|
68 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From start of treatment through 30 days after treatment (estimated to be 3 months)* Adverse events will be graded with CTCAE v. 5.0. * Related indicates adverse events possibly, probably, or definitely related to treatment.
Outcome measures
| Measure |
Dapagliflozin
n=15 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Edema limbs
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Fatigue
|
6 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Fever
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Platelet count decreased
|
12 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
White blood cell decreased
|
10 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Alopecia
|
11 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Hyperhidrosis
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Anemia
|
15 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Atrial fibrillation
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Colitis
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Constipation
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Diarrhea
|
6 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Dry mouth
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Nausea
|
5 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Vomiting
|
3 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Chills
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Sepsis
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Skin infection
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Alanine aminotransferase increased
|
8 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Alkaline phosphatase increased
|
5 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Aspartate aminotransferase increased
|
6 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Lymphocyte count decreased
|
7 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Neutrophil count decreased
|
7 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Anorexia
|
5 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Hypoalbuminemia
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Hyponatremia
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Dysgeusia
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Headache
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Peripheral sensory neuropathy
|
4 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Chronic kidney disease
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Proteinuria
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Pruritus
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Rash maculo-papular
|
2 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Rash on arm
|
1 Participants
|
|
Tolerability as Measured by Number of Participants With Related Adverse Events
Hypotension
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, and End of Treatment (estimated to be 2 months)Population: The three patients who did not complete treatment are not evaluable for this outcome measure.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in Plasma Glucose
Screening
|
110 mg/dL
Interval 71.0 to 158.0
|
|
Changes in Plasma Glucose
Cycle 1 Day 1
|
106.5 mg/dL
Interval 74.0 to 138.0
|
|
Changes in Plasma Glucose
Cycle 1 Day 15
|
108.5 mg/dL
Interval 79.0 to 138.0
|
|
Changes in Plasma Glucose
Cycle 2 Day 1
|
100.5 mg/dL
Interval 79.0 to 164.0
|
|
Changes in Plasma Glucose
Cycle 2 Day 15
|
102.5 mg/dL
Interval 82.0 to 172.0
|
|
Changes in Plasma Glucose
End of Treatment
|
98 mg/dL
Interval 81.0 to 195.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 2 Day 22Population: The three patients who did not complete treatment are not included in this outcome measure and an additional patient is not included as they didn't collect any ketone readings. There are additional patients who missed ketone readings at additional time points.
-Patients are to collect and test ketones weekly while on treatment.
Outcome measures
| Measure |
Dapagliflozin
n=11 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in Ketones
Cycle 2 Day 22
|
0 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 1 Day 1
|
0.5 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 1 Day 8
|
0 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 1 Day 15
|
0 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 1 Day 22
|
0 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 2 Day 1
|
0 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 2 Day 8
|
0 mg/dL
Interval 0.0 to 5.0
|
|
Changes in Ketones
Cycle 2 Day 15
|
0 mg/dL
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Screening and Cycle 2 Day 15Population: The three patients who did not complete treatment are not evaluable for this outcome measure.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in HbA1c
Screening
|
5.95 percentage of glycosylated hemoglobin
Interval 4.2 to 7.2
|
|
Changes in HbA1c
Cycle 2 Day 15
|
5.95 percentage of glycosylated hemoglobin
Interval 5.2 to 7.2
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, and End of Treatment, up to 8 weeksPopulation: The three patients who did not complete treatment are not evaluable for this outcome measure. There are 3 additional patients not evaluable for this outcome measure because 2 patients did not have detectable levels of CA19-9 prior to treatment and 1 patient did not have the end of treatment CA19-9 drawn.
Outcome measures
| Measure |
Dapagliflozin
n=9 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in CA19-9
Cycle 1 Day 1
|
1060 U/mL
Interval 27.3 to 25010.0
|
|
Changes in CA19-9
Cycle 2 Day 1
|
315.6 U/mL
Interval 23.3 to 9250.0
|
|
Changes in CA19-9
End of Treatment
|
256.1 U/mL
Interval 11.3 to 30330.0
|
SECONDARY outcome
Timeframe: From pre-treatment and post-8 weeks of treatmentPopulation: The three patients who did not complete treatment are not evaluable for this outcome measure.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in Total Fat Volume in Visceral Fat Area as Assessed by CT-based Body Composition
Pre-treatment
|
5009.845557 cm^3
Standard Deviation 1894.271988
|
|
Changes in Total Fat Volume in Visceral Fat Area as Assessed by CT-based Body Composition
Post-8 weeks of treatment
|
4334.134004 cm^3
Standard Deviation 2127.102525
|
SECONDARY outcome
Timeframe: From pre-treatment and post-8 weeks of treatmentPopulation: The three patients who did not complete treatment are not evaluable for this outcome measure.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in Total Skeletal Muscle Volume in Visceral Fat Area as Assessed by CT-based Body Composition
Pre-treatment
|
1494.813884 cm^3
Standard Deviation 324.0522377
|
|
Changes in Total Skeletal Muscle Volume in Visceral Fat Area as Assessed by CT-based Body Composition
Post-8 weeks of treatment
|
1360.211117 cm^3
Standard Deviation 315.4997407
|
SECONDARY outcome
Timeframe: From pre-treatment and post-8 weeks of treatmentPopulation: The three patients who did not complete treatment are not evaluable for this outcome measure.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in Total Muscle to Fat Ratio in Visceral Fat Area as Assessed by CT-based Body Composition
Pre-treatment
|
0.378776105 ratio
Standard Deviation 0.274872687
|
|
Changes in Total Muscle to Fat Ratio in Visceral Fat Area as Assessed by CT-based Body Composition
Post-8 weeks of treatment
|
0.518539627 ratio
Standard Deviation 0.638171644
|
SECONDARY outcome
Timeframe: From pre-treatment and post-8 weeks of treatmentPopulation: The three patients who did not complete treatment are not evaluable for this outcome measure.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Changes in CT-quantified Tumor Size
Pre-treatment
|
7.541666667 cm
Standard Deviation 4.825775177
|
|
Changes in CT-quantified Tumor Size
Post-8 weeks of treatment
|
7.358333333 cm
Standard Deviation 5.946038916
|
SECONDARY outcome
Timeframe: From pre-therapy to post-8 weeks of therapyPopulation: The CT scans were unable to determine the scope of tumor necrosis.
Outcome measures
Outcome data not reported
Adverse Events
Dapagliflozin
Serious events: 5 serious events
Other events: 15 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Dapagliflozin
n=15 participants at risk
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
General disorders
Fever
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
Other adverse events
| Measure |
Dapagliflozin
n=15 participants at risk
* Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg)
* Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy.
* Participants will use the BIOSENSE meter once daily
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
15/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Eye disorders
Blurred vision
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
10/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
General disorders
Chills
|
46.7%
7/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
General disorders
Disease progression
|
20.0%
3/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
General disorders
Edema limbs
|
46.7%
7/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
General disorders
Fatigue
|
40.0%
6/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
General disorders
Fever
|
20.0%
3/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Infections and infestations
Biliary tract infection
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Infections and infestations
Papulopustular rash
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Infections and infestations
Salmonella enteritis infection
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Infections and infestations
Skin infection
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Injury, poisoning and procedural complications
Burn
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
53.3%
8/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
46.7%
7/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Anorexia
|
53.3%
8/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
6/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Blood bicarbonate increased
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Blood bilirubin increased
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Creatinine increased
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Lymphocyte count decreased
|
53.3%
8/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Neutrophil count decreased
|
46.7%
7/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Platelet count decreased
|
80.0%
12/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
Weight loss
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Investigations
White blood cell decreased
|
66.7%
10/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
53.3%
8/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
46.7%
7/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
5/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.7%
4/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Renal and urinary disorders
Bladder pain
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
20.0%
3/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Renal and urinary disorders
Glucosuria
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Reproductive system and breast disorders
Vaginal pain
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
4/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
4/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
73.3%
11/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
3/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Peeling of feet
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
2/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash on arm
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Redness in left leg
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Vascular disorders
Hypertension
|
20.0%
3/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.
|
Additional Information
Kian-Huat Lim, M.D.
Washington University School of Medicine
Phone: 314-362-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place