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Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin Phase 4 226

Completed
Clinical Trial NCT02429258 was designed to study Treatment for Type II Diabetes. This was a Phase 4 interventional study that is now completed. The study started on 1 May 2015, with plans to enroll 226 participants. Led by AstraZeneca, the expected completion date was 1 October 2015. The latest data from ClinicalTrials.gov was last updated on 14 June 2017.
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
Official Title

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

Conditions
Type II Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • D1690L00026
NCT ID Number
NCT02429258
Start Date (Actual)
2015-05
Last Update Posted
2017-06-14
Completion Date (Estimated)
2015-10
Enrollment (Estimated)
226
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFarxiga with metformin or insulin
Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Farxiga
Farxiga 10mg/day
Metformin
Metformin background therapy \>/= 1500mg/day
Insulin
Insulin \>/= 30 units
Placebo ComparatorPlacebo with metformin or insulin
Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Placebo
Placebo
Metformin
Metformin background therapy \>/= 1500mg/day
Insulin
Insulin \>/= 30 units
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
Baseline to Week 4
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
Baseline 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 Population
Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
Baseline to Week 4
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Baseline to Week 4
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
Baseline to Week 4
Change in HbA1c From Baseline to Week 4
Baseline to Week 4
Change in Fructosamine From Baseline to Week 4
Baseline to Week 4
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
Baseline to Week 4
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
Baseline to Week 4
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
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26 Study Locations in 1 Countries

Alabama

Research Site, Birmingham, Alabama, United States

Arizona

Research Site, Phoenix, Arizona, United States

California

Research Site, Huntington Park, California, United States
Research Site, Los Angeles, California, United States
Research Site, Sacramento, California, United States
Research Site, San Diego, California, United States
Research Site, West Hills, California, United States

Florida

Research Site, Cooper City, Florida, United States
Research Site, Miami, Florida, United States

Illinois

Research Site, Evanston, Illinois, United States

Maryland

Research Site, Oxon Hill, Maryland, United States

Nebraska

Research Site, Henderson, Nebraska, United States

New York

Research Site, Brooklyn, New York, United States
Research Site, Rochester, New York, United States

North Carolina

Research Site, Greensboro, North Carolina, United States

Ohio

Research Site, Cincinnati, Ohio, United States
Research Site, Dublin, Ohio, United States
Research Site, Franklin, Ohio, United States

Oregon

Research Site, Eugene, Oregon, United States

Pennsylvania

Research Site, Lansdale, Pennsylvania, United States

South Carolina

Research Site, Spartanburg, South Carolina, United States

Tennessee

Research Site, Bartlett, Tennessee, United States

Texas

Research Site, Dallas, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Hurst, Texas, United States

Washington

Research Site, Renton, Washington, United States