A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes (DERIVE)

October 1, 2018 updated by: AstraZeneca

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Site
      • Botevgrad, Bulgaria, 2140
        • Research Site
      • Kozloduy, Bulgaria, 3320
        • Research Site
      • Kyustendil, Bulgaria, 2500
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
      • Stara Zagora, Bulgaria, 6000
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4G2
        • Research Site
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 2N6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6S 0S9
        • Research Site
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • Concord, Ontario, Canada, L4K 4M2
        • Research Site
      • Courtice, Ontario, Canada, L1E 3C3
        • Research Site
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Research Site
      • Guelph, Ontario, Canada, N1H 1B1
        • Research Site
      • London, Ontario, Canada, N6G 5A9
        • Research Site
      • North York, Ontario, Canada, M3J 1N2
        • Research Site
      • Oakville, Ontario, Canada, L6M 4H8
        • Research Site
      • Sudbury, Ontario, Canada, P3E 6C3
        • Research Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Research Site
      • Toronto, Ontario, Canada, M3M 0B2
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 5M3
        • Research Site
  • Czechia
      • Cheb, Czechia, 350 02
        • Research Site
      • Horovice, Czechia, 268 01
        • Research Site
      • Krnov, Czechia, 794 01
        • Research Site
      • Kutna Hora, Czechia, 284 30
        • Research Site
      • Ostrava, Czechia, 702 00
        • Research Site
      • Praha - Klanovice, Czechia, 190 14
        • Research Site
      • Praha 10, Czechia, 104 00
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Bergamo, Italy, 24127
        • Research Site
      • Chieti Scalo, Italy, 66013
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Napoli, Italy, 80138
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Pisa, Italy, 56100
        • Research Site
      • San Giovanni Rotondo, Italy, 71013
        • Research Site
  • Poland
      • Bielsko-Biała, Poland, 43-300
        • Research Site
      • Bydgoszcz, Poland, 85-231
        • Research Site
      • Mrągowo, Poland, 11-700
        • Research Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Research Site
      • Tczew, Poland, 83-110
        • Research Site
      • Wrocław, Poland, 50-403
        • Research Site
      • Łódź, Poland, 90-132
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Alicante, Spain, 03010
        • Research Site
      • Ferrol, Spain, 15405
        • Research Site
      • La Laguna (Tenerife), Spain, 38320
        • Research Site
      • Lérida, Spain, 25198
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Pozuelo de Alarcon, Spain, 28223
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Lund, Sweden, 221 85
        • Research Site
      • Stockholm, Sweden, 11324
        • Research Site
      • Stockholm, Sweden, 111 57
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • California
      • Burbank, California, United States, 91505
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • Concord, California, United States, 94520
        • Research Site
      • Fullerton, California, United States, 92835-3404
        • Research Site
      • Huntington Beach, California, United States, 92648
        • Research Site
      • Los Gatos, California, United States, 95032
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Salinas, California, United States, 93901-4446
        • Research Site
    • Florida
      • Miami, Florida, United States, 33144
        • Research Site
      • Miami, Florida, United States, 33015
        • Research Site
      • Miami Springs, Florida, United States, 33166
        • Research Site
      • Pembroke Pines, Florida, United States, 33027
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Research Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Research Site
    • Michigan
      • Flint, Michigan, United States, 48504
        • Research Site
      • Jackson, Michigan, United States, 39209
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Research Site
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
    • Texas
      • Houston, Texas, United States, 77004
        • Research Site
      • San Antonio, Texas, United States, 78215
        • Research Site
      • San Antonio, Texas, United States, 78224
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female or male aged ≥18 years and <75 years.
  • History of T2DM for more than 12 months.
  • Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
  • Stable anti-diabetic treatment regimen
  • Renal impairment: CKD 3A

Exclusion Criteria:

  • Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
  • Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
  • Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:

Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.

  • History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
  • Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
  • Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
  • Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dapagliflozin
10 mg Tablets, Oral, Once daily, 24 weeks
Drug: Dapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Other Names:
  • Farxiga™
Placebo Comparator: Placebo
Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Drug: Matching Placebo for Dapagliflozin
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time Frame: Baseline, Week 24
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
Time Frame: Baseline, Week 24
To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Baseline, Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
Time Frame: Baseline, Week 24
To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Baseline, Week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
Time Frame: Baseline, Week 24
To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Baseline, Week 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1690C00024

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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