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Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02429258
Enrollment
226
Registered
2015-04-29
Start date
2015-05-31
Completion date
2015-10-31
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes

Brief summary

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Detailed description

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Interventions

DRUGFarxiga

Farxiga 10mg/day

DRUGPlacebo

Placebo

DRUGMetformin

Metformin background therapy \>/= 1500mg/day

DRUGInsulin

Insulin \>/= 30 units

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes mellitus (T2DM) * Treated with either stable dose of metformin alone \> or = to 1500mg/day or stable dose of insulin \> or = to 30 units/day and up to 2 OAD medications for at least 8 weeks * Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening * Body mass index (BMI) \< or = to 45 kg/m2

Exclusion criteria

* For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening * For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening. * Use of sulfonylureas during the 8 weeks prior to screening * Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor * Ingestion of any medication know to affect glucose metabolism for \>7 consecutive days during the 3 months prior to screening * Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening

Design outcomes

Primary

MeasureTime frame
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) SystemBaseline to Week 4

Secondary

MeasureTime frame
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT PopulationBaseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT PopulationBaseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT PopulationBaseline to Week 4
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4Baseline to Week 4
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4Baseline to Week 4
Change in HbA1c From Baseline to Week 4Baseline to Week 4
Change in Fructosamine From Baseline to Week 4Baseline to Week 4
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4Baseline to Week 4
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT PopulationBaseline to Week 4
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4Baseline to Week 4

Countries

United States

Participant flow

Pre-assignment details

226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.

Participants by arm

ArmCount
Dapagliflozin
Dapagliflozin + Metformin or Insulin
50
Placebo
Placebo + Metformin or Insulin
50
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation01
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicTotalDapagliflozinPlacebo
Age, Continuous56.9 Years
STANDARD_DEVIATION 8.47
56.9 Years
STANDARD_DEVIATION 7.11
56.8 Years
STANDARD_DEVIATION 9.71
BMI33.8 kg/m^2
STANDARD_DEVIATION 5.75
34.3 kg/m^2
STANDARD_DEVIATION 5.92
33.2 kg/m^2
STANDARD_DEVIATION 5.59
Hemoglobin A1c (HbA1c)8.34 Percentage
STANDARD_DEVIATION 0.794
8.31 Percentage
STANDARD_DEVIATION 0.785
8.37 Percentage
STANDARD_DEVIATION 0.81
Race/Ethnicity, Customized
American Indian and Alaska Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
25 Participants11 Participants14 Participants
Race/Ethnicity, Customized
More than one race
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Other
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White
75 Participants39 Participants36 Participants
Sex: Female, Male
Female
49 Participants24 Participants25 Participants
Sex: Female, Male
Male
51 Participants26 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 503 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System-18.2 mg/dLStandard Error 4.33
PlaceboChange in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System5.8 mg/dLStandard Error 4.25
p-value: <0.00195% CI: [-36.1, -12]Mixed Models Analysis
Secondary

Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4-49.5 mg/dLStandard Error 6.61
PlaceboChange in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4-13.2 mg/dLStandard Error 6.46
p-value: <0.00195% CI: [-54.7, -17.9]ANCOVA
Secondary

Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4-50.9 mg/dLStandard Error 6.54
PlaceboChange in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4-10.0 mg/dLStandard Error 6.39
p-value: <0.00195% CI: [-59, -22.7]ANCOVA
Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in Fasting Plasma Glucose (FPG) From Baseline to Week 4-26.2 mg/dLStandard Error 5.99
PlaceboChange in Fasting Plasma Glucose (FPG) From Baseline to Week 43.6 mg/dLStandard Error 5.98
p-value: <0.00195% CI: [-46.6, -12.9]ANCOVA
Secondary

Change in Fructosamine From Baseline to Week 4

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in Fructosamine From Baseline to Week 4-20.4 mmol/LStandard Error 3.22
PlaceboChange in Fructosamine From Baseline to Week 4-9.6 mmol/LStandard Error 3.17
p-value: 0.01995% CI: [-19.9, -1.8]ANCOVA
Secondary

Change in HbA1c From Baseline to Week 4

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in HbA1c From Baseline to Week 4-0.51 % AlcStandard Error 0.07
PlaceboChange in HbA1c From Baseline to Week 4-0.28 % AlcStandard Error 0.07
p-value: 0.02495% CI: [-0.43, -0.03]ANCOVA
Secondary

Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population-12.6 Change in percentageStandard Error 2.65
PlaceboChange in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population3.5 Change in percentageStandard Error 2.6
p-value: <0.00195% CI: [-23.5, -8.7]ANCOVA
Secondary

Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population0.3 Change in percentageStandard Error 0.3
PlaceboChange in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population-0.6 Change in percentageStandard Error 0.29
p-value: 0.02395% CI: [0.1, 1.8]ANCOVA
Secondary

Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population12.2 Change in percentageStandard Error 2.6
PlaceboChange in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population-2.8 Change in percentageStandard Error 2.55
p-value: <0.00195% CI: [7.7, 22.2]ANCOVA
Secondary

Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population8.4 10^-9 min^-1Standard Error 2.07
PlaceboChange in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population1.4 10^-9 min^-1Standard Error 1.98
p-value: 0.01795% CI: [1.3, 12.7]ANCOVA
Secondary

Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4

Time frame: Baseline to Week 4

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DapagliflozinChange in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4-10.0 mg/dLStandard Error 4.14
PlaceboChange in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 45.3 mg/dLStandard Error 4.06
p-value: 0.0195% CI: [-26.8, -3.8]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026