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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

June 15, 2015

Primary Completion (Actual)

November 7, 2017

Study Completion (Actual)

November 7, 2017

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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