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

May 18, 2017 updated by: AstraZeneca
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • 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
    • Florida
      • Cooper City, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
    • Illinois
      • Evanston, Illinois, United States
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, United States
        • Research Site
    • Nebraska
      • Henderson, Nebraska, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Dublin, Ohio, United States
        • Research Site
      • Franklin, Ohio, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
    • Pennsylvania
      • Lansdale, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Research Site
    • Tennessee
      • Bartlett, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Hurst, Texas, United States
        • Research Site
    • Washington
      • Renton, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Time Frame: 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
Time Frame: Baseline to Week 4
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
Time Frame: Baseline to Week 4
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
Time Frame: Baseline to Week 4
Baseline to Week 4
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Time Frame: 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
Time Frame: Baseline to Week 4
Baseline to Week 4
Change in HbA1c From Baseline to Week 4
Time Frame: Baseline to Week 4
Baseline to Week 4
Change in Fructosamine From Baseline to Week 4
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to Week 4
Baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690L00026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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