Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
1 other identifier
interventional
226
1 country
26
Brief Summary
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
Shorter than P25 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
April 11, 2017
CompletedJune 14, 2017
April 1, 2017
5 months
April 8, 2015
October 7, 2016
May 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
Farxiga with metformin or insulin
EXPERIMENTALFarxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Placebo with metformin or insulin
PLACEBO COMPARATORPlacebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Interventions
Metformin background therapy \>/= 1500mg/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
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
Research Site
Cooper City, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Evanston, Illinois, United States
Research Site
Oxon Hill, Maryland, United States
Research Site
Henderson, Nebraska, United States
Research Site
Brooklyn, New York, United States
Research Site
Rochester, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dublin, Ohio, United States
Research Site
Franklin, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Lansdale, Pennsylvania, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Bartlett, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Hurst, Texas, United States
Research Site
Renton, Washington, United States
Related Publications (1)
Henry RR, Strange P, Zhou R, Pettus J, Shi L, Zhuplatov SB, Mansfield T, Klein D, Katz A. Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Nov;20(11):715-724. doi: 10.1089/dia.2018.0052. Epub 2018 Sep 14.
PMID: 30222367DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sergey Zhuplatov MD, PhD
- Organization
- AstraZeneca, PLL
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 29, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
June 14, 2017
Results First Posted
April 11, 2017
Record last verified: 2017-04