Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

December 6, 2018 updated by: AstraZeneca

A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

695

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

  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Balatonfüred, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1033
        • Research Site
      • Budapest, Hungary, 1088
        • Research Site
      • Budaörs, Hungary, 2040
        • Research Site
      • Debrecen, Hungary, 4025
        • Research Site
      • Eger, Hungary, 3300
        • Research Site
      • Godollo, Hungary, 2100
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Gödöllő, Hungary, 2100
        • Research Site
      • Kecskemét, Hungary, 6000
        • Research Site
      • Komárom, Hungary, 2921
        • Research Site
      • Létavértes, Hungary, 4281
        • Research Site
      • Nyíregyháza, Hungary, 4405
        • Research Site
      • Pécs, Hungary, 7623
        • Research Site
      • Szeged, Hungary, 6722
        • Research Site
      • Szekszárd, Hungary, 7100
        • Research Site
  • Poland
      • Lodz, Poland, 94-255
        • Research Site
      • Lublin, Poland, 20-538
        • Research Site
      • Oświęcim, Poland, 32-600
        • Research Site
      • Parczew, Poland, 21-200
        • Research Site
      • Poznań, Poland, 61-655
        • Research Site
      • Torun, Poland, 87-100
        • Research Site
      • Zgierz, Poland, 95-100
        • Research Site
      • Łódź, Poland, 94-048
        • Research Site
  • Romania
      • Baia Mare, Romania, 430222
        • Research Site
      • Bucuresti, Romania, 020475
        • Research Site
      • Bucuresti, Romania, 010192
        • Research Site
      • Bucuresti, Romania, 010825
        • Research Site
      • Galati, Romania, 800578
        • Research Site
      • Oradea, Romania, 410169
        • Research Site
      • Oradea, Romania, 410032
        • Research Site
      • Oradea, Romania, 410469
        • Research Site
      • Ploiesti, Romania, 100342
        • Research Site
      • Timișoara, Romania, 300456
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97517
        • Research Site
      • Bardejov, Slovakia, 085 01
        • Research Site
      • Bratislava, Slovakia, 81108
        • Research Site
      • Bratislava, Slovakia, 85101
        • Research Site
      • Bratislava, Slovakia, 82106
        • Research Site
      • Dolny Kubin, Slovakia, 026 01
        • Research Site
      • Kosice, Slovakia, 04001
        • Research Site
      • Levice, Slovakia, 934 01
        • Research Site
      • Levice, Slovakia, 93401
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Nitra, Slovakia, 94911
        • Research Site
      • Pezinok, Slovakia, 90201
        • Research Site
      • Sturovo, Slovakia, 943 01
        • Research Site
      • Trebišov, Slovakia, 07501
        • Research Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
      • Cape Town, South Africa, 7925
        • Research Site
      • Johannesburg, South Africa, 1818
        • Research Site
      • Kempton Park, South Africa, 1619
        • Research Site
      • Middelburg, South Africa, 1055
        • Research Site
      • Parow, South Africa, 7505
        • Research Site
      • Port Elizabeth, South Africa, 6014
        • Research Site
      • Pretoria, South Africa, 0001
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Tuscumbia, Alabama, United States, 35674
        • Research Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Research Site
      • Tempe, Arizona, United States, 85283
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Chula Vista, California, United States, 91911
        • Research Site
      • El Cajon, California, United States, 92020
        • Research Site
      • Fresno, California, United States, 93720
        • Research Site
      • La Mesa, California, United States, 91942
        • Research Site
      • Long Beach, California, United States, 90807
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Mission Hills, California, United States, 91345
        • Research Site
      • Montclair, California, United States, 91763
        • Research Site
      • Oceanside, California, United States, 92056
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
      • San Diego, California, United States, 92114
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
      • Van Nuys, California, United States, 91405
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Research Site
      • Clearwater, Florida, United States, 33765
        • Research Site
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Fort Lauderdale, Florida, United States, 33316
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Jacksonville, Florida, United States, 32277
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
      • Miami, Florida, United States, 33175
        • Research Site
      • Miami, Florida, United States, 33133
        • Research Site
      • Miami, Florida, United States, 33142
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • North Miami Beach, Florida, United States, 33162
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Orlando, Florida, United States, 32801
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • Williston, Florida, United States, 32696
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Research Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Research Site
      • Evansville, Indiana, United States, 47714
        • Research Site
      • Franklin, Indiana, United States, 46131
        • Research Site
      • Muncie, Indiana, United States, 47304
        • Research Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Research Site
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Research Site
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Research Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Research Site
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Vandalia, Ohio, United States, 45377
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 91307
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Research Site
      • Greer, South Carolina, United States, 29651
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
      • Summerville, South Carolina, United States, 29485
        • Research Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Site
      • Dallas, Texas, United States, 75218
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
      • Houston, Texas, United States, 77079
        • Research Site
      • Pearland, Texas, United States, 77584
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • Tomball, Texas, United States, 77375
        • Research Site
    • Utah
      • Clinton, Utah, United States, 84015
        • Research Site
      • Salt Lake City, Utah, United States, 84102
        • Research Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • Research Site
      • Manassas, Virginia, United States, 20110
        • Research Site
      • Richmond, Virginia, United States, 23294
        • 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 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Has a diagnosis of T2DM.
  • Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
  • Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.

Exclusion criteria

  • FPG ≥280 mg/dL (15.6 mmol/L).
  • Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
  • Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
  • Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
  • Known active proliferative retinopathy.
  • History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
  • History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
  • History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.

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: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
Drug: Exantide with Dapagliflozin
2 mg weekly suspension injection and 10 mg Dapagliflozin
Experimental: Exenatide Once Weekly 2 mg Alone
Drug: Exentide
2 mg
Active Comparator: Dapagliflozin Once Daily 10 mg Alone
Drug: Dapagliflozin
10 mg once daily Dapagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 28
Time Frame: Baseline to Week 28
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight From Baseline to Week 28
Time Frame: Baseline to Week 28
To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28
Time Frame: Baseline to Week 28
To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
Time Frame: Baseline to Week 28
To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
Time Frame: Baseline to Week 28
To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 2
Time Frame: Baseline to Week 2
To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 2
Percentage of Patients Achieving HbA1c <7% at Week 28
Time Frame: Baseline to Week 28
To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28
Change in Systolic Blood Pressure From Baseline to Week 28
Time Frame: Baseline to Week 28
To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28

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)

September 4, 2014

Primary Completion (Actual)

April 26, 2016

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Actual)

December 31, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5553C00003
  • 2014-003503-29 (EudraCT Number)

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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