Trial Outcomes & Findings for ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study (NCT NCT02613897)

NCT ID: NCT02613897

Last Updated: 2019-08-14

Results Overview

All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: Baseline and 16 weeks
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea).
Overall Study STARTED	22	22	12
Overall Study COMPLETED	22	22	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study

Baseline characteristics by cohort

Measure	Dapa/Saxa n=22 Participants Subjects with type 2 diabetes were enrolled into this study and received the intervention of Dapagliflozin plus Saxa	Dapa/Placebo n=22 Participants Subjects with type 2 diabetes were enrolled into this study and received the intervention of Dapagliflozin plus placebo	Placebo/Placebo n=12 Participants Subjects with type 2 diabetes were enrolled into this study and received the intervention of placebo plus placebo	Total n=56 Participants Total of all reporting groups
Age, Continuous	52 Years STANDARD_DEVIATION 2 • n=5 Participants	52 Years STANDARD_DEVIATION 2 • n=7 Participants	52 Years STANDARD_DEVIATION 2 • n=5 Participants	52 Years STANDARD_DEVIATION 2 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	2 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	18 participants n=5 Participants	18 participants n=7 Participants	9 participants n=5 Participants	45 participants n=4 Participants
Race/Ethnicity, Customized White	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	12 participants n=5 Participants	56 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP.

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in Endogenous Glucose Production (EGP) Baseline Measurement	2.45 mg/kg*min Standard Error 0.05	2.56 mg/kg*min Standard Error 0.04	1.95 mg/kg*min Standard Error 0.05
Change in Endogenous Glucose Production (EGP) 16 weeks	2.4 mg/kg*min Standard Error 0.02	2.8 mg/kg*min Standard Error 0.01	2.15 mg/kg*min Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Change in body weight from baseline to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in Body Weight	-2.28 Kg Standard Deviation 0.67	-1.76 Kg Standard Deviation 0.88	0.26 Kg Standard Deviation 0.7

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Change in BMI (body mass index) from study start to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in BMI	-0.8 Kg/m^2 Standard Deviation 0.24	-0.66 Kg/m^2 Standard Deviation 0.33	0.16 Kg/m^2 Standard Deviation 0.24

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Change in blood glucose level measured over a 3 month period from study start to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
HBA1c	-1.67 percentage change in blood glucose level Standard Deviation 0.35	-1.46 percentage change in blood glucose level Standard Deviation 0.22	0.44 percentage change in blood glucose level Standard Deviation 0.36

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Measure of change in OGTT from study start to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Mean Oral Glucose Tolerance Test (OGTT)	-49.62 mg/dl Standard Deviation 9.03	-44.24 mg/dl Standard Deviation 7.76	20.26 mg/dl Standard Deviation 9.25

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Change in lipid oxidation percentage from baseline to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in Lipid Oxidation	-11.87 percentage of oxidation Standard Deviation 2.52	22.02 percentage of oxidation Standard Deviation 2.81	-6.69 percentage of oxidation Standard Deviation 4.95

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Change in percentage of glucose oxidation from study start to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in Glucose Oxidation	-22.07 percentage of oxidation Standard Deviation 2.22	-46.54 percentage of oxidation Standard Deviation 2.79	4.65 percentage of oxidation Standard Deviation 4.89

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

A measure of the change in fasting plasma glucagon from study start to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in Fasting Plasma Glucagon (FPG)	-28.52 mg/dl Standard Deviation 5.74	26.89 mg/dl Standard Deviation 5.2	6.88 mg/dl Standard Deviation 5.09

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Measure of change in Free Fatty Acids from study start to 16 weeks

Outcome measures

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 Participants Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 Participants Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 Participants Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea). Placebo: Placebo
Change in Free Fatty Acids (FFA)	-0.06 mEq/L Standard Deviation 0.01	-0.01 mEq/L Standard Deviation 0.02	0.00 mEq/L Standard Deviation 0.7

Adverse Events

DAPA/SAXA (Dapagliflozin Plus Saxagliptin)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

DAPA (Dapagliflozin Plus Placebo)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

PCB (Placebo Plus Placebo)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DAPA/SAXA (Dapagliflozin Plus Saxagliptin) n=22 participants at risk Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).	DAPA (Dapagliflozin Plus Placebo) n=22 participants at risk Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).	PCB (Placebo Plus Placebo) n=12 participants at risk Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea).
Renal and urinary disorders Increased urinary frequency	13.6% 3/22 • Number of events 3 • Adverse events were captured from baseline to 16 weeks	13.6% 3/22 • Number of events 3 • Adverse events were captured from baseline to 16 weeks	8.3% 1/12 • Number of events 1 • Adverse events were captured from baseline to 16 weeks
Reproductive system and breast disorders Vaginal Itching	9.1% 2/22 • Number of events 2 • Adverse events were captured from baseline to 16 weeks	9.1% 2/22 • Number of events 2 • Adverse events were captured from baseline to 16 weeks	8.3% 1/12 • Number of events 1 • Adverse events were captured from baseline to 16 weeks
Gastrointestinal disorders Nausea	9.1% 2/22 • Number of events 2 • Adverse events were captured from baseline to 16 weeks	4.5% 1/22 • Number of events 1 • Adverse events were captured from baseline to 16 weeks	0.00% 0/12 • Adverse events were captured from baseline to 16 weeks
Nervous system disorders Light headache	4.5% 1/22 • Number of events 1 • Adverse events were captured from baseline to 16 weeks	0.00% 0/22 • Adverse events were captured from baseline to 16 weeks	0.00% 0/12 • Adverse events were captured from baseline to 16 weeks
Gastrointestinal disorders Dry Mouth	9.1% 2/22 • Number of events 2 • Adverse events were captured from baseline to 16 weeks	9.1% 2/22 • Number of events 2 • Adverse events were captured from baseline to 16 weeks	8.3% 1/12 • Number of events 1 • Adverse events were captured from baseline to 16 weeks
Renal and urinary disorders Urinary Tract Infection	4.5% 1/22 • Number of events 1 • Adverse events were captured from baseline to 16 weeks	4.5% 1/22 • Number of events 1 • Adverse events were captured from baseline to 16 weeks	0.00% 0/12 • Adverse events were captured from baseline to 16 weeks

Additional Information

Yuejuan Qin

University of Texas Health San Antonio

Phone: 210-617-5300

Email: qiny@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place