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

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ClinicalTrials.gov Identifier: NCT02429258
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : April 11, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Type II Diabetes Drug: Farxiga Drug: Placebo Drug: Metformin Drug: Insulin Phase 4

Detailed Description:
Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
Experimental: Farxiga with metformin or insulin
Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
 Drug: Farxiga
Farxiga 10mg/day

Drug: Metformin
Metformin background therapy >/= 1500mg/day

Drug: Insulin
Insulin >/= 30 units
Placebo Comparator: Placebo with metformin or insulin
Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
 Drug: Placebo
Placebo

Drug: Metformin
Metformin background therapy >/= 1500mg/day

Drug: Insulin
Insulin >/= 30 units


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  6. 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 ]
  7. Change in HbA1c From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  8. Change in Fructosamine From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  9. Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  10. Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population [ Time Frame: Baseline to Week 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429258


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
Research Site
Phoenix, Arizona, United States
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
United States, Florida
Research Site
Cooper City, Florida, United States
Research Site
Miami, Florida, United States
United States, Illinois
Research Site
Evanston, Illinois, United States
United States, Maryland
Research Site
Oxon Hill, Maryland, United States
United States, Nebraska
Research Site
Henderson, Nebraska, United States
United States, New York
Research Site
Brooklyn, New York, United States
Research Site
Rochester, New York, United States
United States, North Carolina
Research Site
Greensboro, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Dublin, Ohio, United States
Research Site
Franklin, Ohio, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
United States, Pennsylvania
Research Site
Lansdale, Pennsylvania, United States
United States, South Carolina
Research Site
Spartanburg, South Carolina, United States
United States, Tennessee
Research Site
Bartlett, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Hurst, Texas, United States
United States, Washington
Research Site
Renton, Washington, United States
Sponsors and Collaborators
AstraZeneca
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02429258    
Other Study ID Numbers: D1690L00026
First Posted: April 29, 2015    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: June 14, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
 Dapagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action