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

Primary Purpose

Type II Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Farxiga
Placebo
Metformin
Insulin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Farxiga with metformin or insulin

Placebo with metformin or insulin

Arm Description

Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2015
Last Updated
May 18, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02429258
Brief Title
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Farxiga with metformin or insulin
Arm Type
Experimental
Arm Description
Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
Arm Title
Placebo with metformin or insulin
Arm Type
Placebo Comparator
Arm Description
Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
Intervention Type
Drug
Intervention Name(s)
Farxiga
Intervention Description
Farxiga 10mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin background therapy >/= 1500mg/day
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin >/= 30 units
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Time Frame
Baseline to Week 4
Title
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
Title
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
Title
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
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Time Frame
Baseline to Week 4
Title
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
Title
Change in HbA1c From Baseline to Week 4
Time Frame
Baseline to Week 4
Title
Change in Fructosamine From Baseline to Week 4
Time Frame
Baseline to Week 4
Title
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
Time Frame
Baseline to Week 4
Title
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
Time Frame
Baseline to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Huntington Park
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
West Hills
State/Province
California
Country
United States
Facility Name
Research Site
City
Cooper City
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oxon Hill
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dublin
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Franklin
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Lansdale
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Bartlett
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Hurst
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30222367
Citation
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.
Results Reference
derived

Learn more about this trial

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

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