Trial Outcomes & Findings for To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients (NCT NCT04445714)
NCT ID: NCT04445714
Last Updated: 2024-11-12
Results Overview
Adverse events (AEs) including serious adverse events (SAEs), AEs leading to discontinuation (DAE), and adverse events of special interest (volume depletion, renal events, major hypoglycemic events, fractures, urinary/genital tract infections diabetic ketoacidosis, amputations and hospitalization for heart failure)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
196 participants
Primary outcome timeframe
Baseline to End of Study (Week 26)
Results posted on
2024-11-12
Participant Flow
Participant milestones
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Overall Study
STARTED
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196
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Overall Study
COMPLETED
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173
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Overall Study
NOT COMPLETED
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23
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Reasons for withdrawal
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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Overall Study
Discontinuation of the study
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14
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Overall Study
High plasma glucose-fasting and HbA1c; investigator decision to withdraw participant
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1
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Overall Study
Withdrawal of Informed Consent
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8
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Baseline Characteristics
Data only available for 151 participants
Baseline characteristics by cohort
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mgOverall
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Age, Continuous
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52.2 Years
STANDARD_DEVIATION 10.27 • n=196 Participants
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Sex: Female, Male
Female
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76 Participants
n=196 Participants
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Sex: Female, Male
Male
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120 Participants
n=196 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=196 Participants
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Race (NIH/OMB)
Asian
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196 Participants
n=196 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=196 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=196 Participants
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Race (NIH/OMB)
White
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0 Participants
n=196 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=196 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=196 Participants
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Height
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163 centimeters
STANDARD_DEVIATION 8.62 • n=196 Participants
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Weight
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74.2 kilograms
STANDARD_DEVIATION 12.59 • n=196 Participants
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Waist circumference
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97.5 centimeters
STANDARD_DEVIATION 12.76 • n=196 Participants
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Body mass index
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28.0 kg/m^2
STANDARD_DEVIATION 4.35 • n=196 Participants
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Glycated haemoglobin
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8.6 percentage of glycated haemoglobin
STANDARD_DEVIATION 0.77 • n=196 Participants
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Fasting plasma glucose
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161.8 mg/dL
STANDARD_DEVIATION 52.30 • n=196 Participants
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Systolic blood pressure
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125.7 mmHg
STANDARD_DEVIATION 9.27 • n=151 Participants • Data only available for 151 participants
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PRIMARY outcome
Timeframe: Baseline to End of Study (Week 26)Population: Safety Population
Adverse events (AEs) including serious adverse events (SAEs), AEs leading to discontinuation (DAE), and adverse events of special interest (volume depletion, renal events, major hypoglycemic events, fractures, urinary/genital tract infections diabetic ketoacidosis, amputations and hospitalization for heart failure)
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
Adverse events of special interest
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4 events
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Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
AEs
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40 events
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Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
SAEs
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0 events
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Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
DAEs
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0 events
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PRIMARY outcome
Timeframe: Enrolment (Week -1) to End of Study (Week 26)Population: Safety Population
Clinical laboratory results were presented separately for haematology, clinical chemistry, and urinalysis variables. The number of participants with clinically important (haematology and clinical chemistry) or clinically significant (urinalysis) abnormalities in safety laboratory values are presented.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Clinically Important or Significant Abnormalities in Safety Laboratory Values
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0 Participants
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PRIMARY outcome
Timeframe: Time Frame: Baseline to End of Study (Week 26)Population: Safety Population
The number of participants with clinically important abnormalities in ECG values are presented.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Clinically Important Abnormalities in ECG Values
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0 Participants
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PRIMARY outcome
Timeframe: Enrolment (Week -1) to End of Study (Week 26)Population: Safety Population
The number of participants with clinically important abnormalities in vital signs (pulse and blood pressure).
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure)
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0 Participants
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PRIMARY outcome
Timeframe: Enrolment (Week -1) to End of Study (Week 26)Population: Safety Population
The number of participants with clinically significant abnormalities in physical examinations.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Clinically Significant Abnormalities in Physical Examinations
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0 Participants
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring HbA1c change at week 24 compared to baseline.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline
Baseline (Visit 2)
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8.6 percentage of glycated haemoglobin
Standard Deviation 0.77
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Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline
Week 24
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7.4 percentage of glycated haemoglobin
Standard Deviation 0.98
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Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline
Change from Baseline
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-1.2 percentage of glycated haemoglobin
Standard Deviation 1.09
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring weight change at week 24 compared to baseline.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Weight Change at Week 24 Compared to Baseline
Baseline (Visit 2)
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74.2 kilograms
Standard Deviation 12.59
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Weight Change at Week 24 Compared to Baseline
Week 24
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72.2 kilograms
Standard Deviation 11.51
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Weight Change at Week 24 Compared to Baseline
Change from Baseline
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-2.1 kilograms
Standard Deviation 3.98
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring systolic blood pressure change at week 24 compared to baseline.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Systolic Blood Pressure Change at Week 24 Compared to Baseline
Baseline (Visit 2)
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125.7 mmHg
Standard Deviation 9.27
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Systolic Blood Pressure Change at Week 24 Compared to Baseline
Week 24
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124.5 mmHg
Standard Deviation 10.33
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Systolic Blood Pressure Change at Week 24 Compared to Baseline
Change from Baseline
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-0.2 mmHg
Standard Deviation 12.90
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring fasting plasma glucose change at week 24 compared to baseline.
Outcome measures
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 Participants
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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|---|---|
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Fasting Plasma Glucose Change at Week 24 Compared to Baseline
Baseline (Visit 2)
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161.8 mg/dL
Standard Deviation 52.30
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Fasting Plasma Glucose Change at Week 24 Compared to Baseline
Week 24
|
136.7 mg/dL
Standard Deviation 41.98
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Fasting Plasma Glucose Change at Week 24 Compared to Baseline
Change from Baseline
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-24.4 mg/dL
Standard Deviation 62.89
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Adverse Events
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg
n=196 participants at risk
All participants were given once daily fixed dose combination of Dapagliflozin 10 mg / Saxagliptin 5 mg administered orally at the same time of the day throughout the study.
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Immune system disorders
Hypersensitivity
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Infections and infestations
Balanitis candida
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Infections and infestations
Nasopharyngitis
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1.5%
3/196 • Number of events 3 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Infections and infestations
Pharyngitis
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Infections and infestations
Trichomoniasis
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Infections and infestations
Urinary tract infection
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2.6%
5/196 • Number of events 7 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Investigations
Blood creatine phosphokinase increased
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Investigations
Blood glucose decreased
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Metabolism and nutrition disorders
Hyperkalaemia
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Musculoskeletal and connective tissue disorders
Muscle spasms
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Cardiac disorders
Left ventricular dysfunction
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Nervous system disorders
Headache
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Nervous system disorders
Paraesthesia
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Nervous system disorders
Polyneuropathy
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Reproductive system and breast disorders
Balanoposthitis
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1.5%
3/196 • Number of events 4 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Respiratory, thoracic and mediastinal disorders
Cough
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Gastrointestinal disorders
Abdominal pain upper
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Gastrointestinal disorders
Gastritis
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0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Gastrointestinal disorders
Nausea
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1.0%
2/196 • Number of events 2 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Gastrointestinal disorders
Vomiting
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1.0%
2/196 • Number of events 2 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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General disorders
Pain
|
0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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General disorders
Pyrexia
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2.6%
5/196 • Number of events 5 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.51%
1/196 • Number of events 1 • Week 0 to End of Study (26 weeks)
An adverse event was any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of or make presentations related to the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER