Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

December 17, 2018 updated by: AstraZeneca

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin

Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

464

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
      • Balatonfured, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1134
        • Research Site
      • Budapest, Hungary, 1033
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1088
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Eger, Hungary, 3300
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Gödöllő, Hungary, 2100
        • Research Site
      • Komárom, Hungary, 2921
        • Research Site
      • Létavértes, Hungary, 4281
        • Research Site
      • Pécs, Hungary, 7623
        • Research Site
      • Satoraljaujhely, Hungary, 3980
        • Research Site
      • Szeged, Hungary, 6722
        • Research Site
      • Szekszárd, Hungary, 7100
        • Research Site
  • Poland
      • Lublin, Poland, 20-538
        • Research Site
      • Lublin, Poland, 20-363
        • Research Site
      • Oświęcim, Poland, 32-600
        • Research Site
      • Poznań, Poland, 61-655
        • Research Site
      • Torun, Poland, 87-100
        • Research Site
      • Zamość, Poland, 22-400
        • 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
      • Ploiesti, Romania, 100342
        • Research Site
      • Tg Mures, Romania, 540142
        • Research Site
      • Timișoara, Romania, 300456
        • Research Site
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Research Site
      • Bratislava, Slovakia, 81108
        • 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, 94901
        • Research Site
      • Nitra, Slovakia, 94911
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Sturovo, Slovakia, 94301
        • Research Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
      • Kempton Park, South Africa, 1619
        • Research Site
      • Krugersdorp, South Africa, 1739
        • Research Site
      • Paarl, South Africa, 7646
        • Research Site
      • Pretoria, South Africa, 0087
        • Research Site
      • Pretoria, South Africa, 184
        • Research Site
      • Somerset West, South Africa, 7130
        • Research Site
      • Worcester, South Africa, 6850
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Muscle Shoals, Alabama, United States, 35662
        • Research Site
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Research Site
    • California
      • Chino, California, United States, 91710
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • El Cajon, California, United States, 92020
        • Research Site
      • Fresno, California, United States, 93720
        • 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
      • Tustin, California, United States, 92780
        • Research Site
      • West Hills, California, United States, 91307
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Research Site
      • Brooksville, Florida, United States, 34601
        • Research Site
      • Chiefland, Florida, United States, 32626
        • 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, 33175
        • Research Site
      • Miami, Florida, United States, 33133
        • Research Site
      • Miami, Florida, United States, 33142
        • Research Site
      • Miami, Florida, United States, 33125
        • Research Site
      • North Miami Beach, Florida, United States, 33162
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
    • Georgia
      • Columbus, Georgia, United States, 31406
        • 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
    • Kansas
      • Newton, Kansas, United States, 67114
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Research Site
      • New Orleans, Louisiana, United States, 70112
        • Research Site
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Research Site
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Research Site
    • North Carolina
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
      • Morganton, North Carolina, United States, 28655
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Dayton, Ohio, United States, 45417
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 91307
        • Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Research Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Research Site
      • Kingsport, Tennessee, United States, 37660
        • Research Site
    • Texas
      • Austin, Texas, United States, 78705
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • Dallas, Texas, United States, 75208
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
      • Houston, Texas, United States, 77070
        • Research Site
      • Houston, Texas, United States, 77079
        • Research Site
    • Utah
      • Clinton, Utah, United States, 84015
        • Research Site
      • Ogden, Utah, United States, 84405
        • Research Site
      • Salt Lake City, Utah, United States, 84102
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Port Orchard, Washington, United States, 98366
        • 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 Type 2 Diabetes Mellitus (T2DM)
  • Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
  • Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)

  • Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:

    1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
    2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit

Exclusion criteria:

  • Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
  • History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
  • Positive serological test for hepatitis B or hepatitis C

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exenatide
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Drug: Exenatide
2 mg weekly suspension injection
PLACEBO_COMPARATOR: Placebo
Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Drug: Exenatide matching placebo
Once weekly Placebo injection

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 in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
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 in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
Time Frame: Baseline to Week 28
To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at Week 28
Time Frame: Baseline to Week 28
To compare the percentage of participants achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Baseline to Week 28
Change From Baseline to Week 28 in Daily Insulin Dose
Time Frame: Baseline to Week 28
To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
Time Frame: Baseline to Week 28
To compare the percentage of participants achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.
Baseline to Week 28
Change in Seated Systolic Blood Pressure From Baseline to Week 28
Time Frame: Baseline to Week 28
To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
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

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 6, 2014

Primary Completion (ACTUAL)

August 29, 2016

Study Completion (ACTUAL)

August 29, 2016

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)

January 8, 2019

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5553C00002
  • 2014-003502-33 (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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