Diabetes MellitusPhase 3NCT02229383

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

A Phase 3 study testing Exenatide in people with Diabetes Mellitus, run by AstraZeneca at 123 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 464 participants
Where: 123 sitesin 6 countries
Study dates: 6 Sep 2014to 29 Aug 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
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

Who cannot join

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

Trial locations and contacts

123 sites in 6 countries.

Country

City, postcode or hospital

123 sites in 6 countries

United States68 sites

Research Site
Austin, Texas, 78705
Research Site
Avon, Indiana, 46123
Research Site
Bellevue, Nebraska, 68005
Research Site
Birmingham, Alabama, 35235
Research Site
Boynton Beach, Florida, 33437
Research Site
Brooksville, Florida, 34601
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Chicago, Illinois, 60607
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Chiefland, Florida, 32626
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Chino, California, 91710
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Chula Vista, California, 91910
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Cincinnati, Ohio, 45242
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Clearwater, Florida, 33765
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Cleveland, Ohio, 44122
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Clinton, Utah, 84015
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Columbus, Georgia, 31406
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Coral Gables, Florida, 33134
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Dakota Dunes, South Dakota, 57049
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Dallas, Texas, 75208
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Dallas, Texas, 75230
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Dayton, Ohio, 45417
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El Cajon, California, 92020
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Evansville, Indiana, 47714
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Fort Lauderdale, Florida, 33316
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Franklin, Indiana, 46131
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Fresno, California, 93720
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Greer, South Carolina, 29651
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Haddon Heights, New Jersey, 08035
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Hazelwood, Missouri, 63042
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Hialeah, Florida, 33012
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Houston, Texas, 77030
Research Site
Houston, Texas, 77070
Research Site
Houston, Texas, 77079
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Houston, Texas, 77090
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Huntsville, Alabama, 35801
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Jacksonville, Florida, 32256
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Jacksonville, Florida, 32277
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Johnson City, Tennessee, 37604
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Kingsport, Tennessee, 37660
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Long Beach, California, 90807
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Los Angeles, California, 90057
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Manassas, Virginia, 20110
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33125
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33133
Research Site
Miami, Florida, 33142
Research Site
Miami, Florida, 33175
Research Site
Mission Hills, California, 91345
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Monroe, Louisiana, 71203
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Mooresville, North Carolina, 28117
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Morehead City, North Carolina, 28557
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Morganton, North Carolina, 28655
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Muscle Shoals, Alabama, 35662
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New Orleans, Louisiana, 70112
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Newton, Kansas, 67114
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North Miami Beach, Florida, 33162
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Ogden, Utah, 84405
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Omaha, Nebraska, 68114
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 91307
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Port Orchard, Washington, 98366
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Richmond, Virginia, 23294
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Salt Lake City, Utah, 84102
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Spartanburg, South Carolina, 29303
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Tampa, Florida, 33603
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Tempe, Arizona, 85283
Research Site
Tustin, California, 92780
Research Site
West Hills, California, 91307

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Hungary17 sites

Research Site
Baja, 6500
Research Site
Balatonfüred, 8230
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Budapest, 1033
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Budapest, 1036
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Budapest, 1083
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Budapest, 1088
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Budapest, 1134
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Debrecen, 4032
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Eger, 3300
Research Site
Gödöllő, 2100
Research Site
Gyula, 5700
Research Site
Komárom, 2921
Research Site
Létavértes, 4281
Research Site
Pécs, 7623
Research Site
Sátoraljaújhely, 3980
Research Site
Szeged, 6722
Research Site
Szekszárd, 7100

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Slovakia12 sites

Research Site
Bardejov, 08501
Research Site
Bratislava, 81108
Research Site
Bratislava, 82106
Research Site
Dolný Kubín, 026 01
Research Site
Košice, 04001
Research Site
Levice, 934 01
Research Site
Levice, 93401
Research Site
Lučenec, 984 01
Research Site
Nitra, 94901
Research Site
Nitra, 94911
Research Site
Prešov, 080 01
Research Site
Štúrovo, 94301

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Romania10 sites

Research Site
Baia Mare, 430222
Research Site
Bucharest, 010192
Research Site
Bucharest, 010825
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Bucharest, 020475
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Galati, 800578
Research Site
Oradea, 410032
Research Site
Oradea, 410169
Research Site
Ploieşti, 100342
Research Site
Tg Mures, 540142
Research Site
Timișoara, 300456

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Poland8 sites

Research Site
Lodz, 94-048
Research Site
Lublin, 20-363
Research Site
Lublin, 20-538
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Oświęcim, 32-600
Research Site
Poznan, 61-655
Research Site
Torun, 87-100
Research Site
Zamość, 22-400
Research Site
Zgierz, 95-100

Other trials in Poland

South Africa8 sites

Research Site
Bloemfontein, 9301
Research Site
Kempton Park, 1619
Research Site
Krugersdorp, 1739
Research Site
Paarl, 7646
Research Site
Pretoria, 0087
Research Site
Pretoria, 184
Research Site
Somerset West, 7130
Research Site
Worcester, 6850

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About this study

Official title: 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.

Conditions: Diabetes Mellitus
Being tested: Exenatide, Exenatide matching placebo
Keywords: Diabetes Mellitus, Exenatide, Diabetes drug, Treatment efficacy, Placebo, Metabolism, Cardiovascilar metabolic
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExenatideDrug
2 mg weekly suspension injection
Exenatide matching placeboDrug
Once weekly Placebo injection

Study groups in NCT02229383
Study group	Role	What they receive
Exenatide	Experimental	Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin Receives: Drug: Exenatide
Placebo	Placebo comparator	Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin Receives: Drug: Exenatide matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c From 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.
Measured: Baseline to Week 28

Secondary outcomes (6)

Change in Body Weight From 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.
Measured: Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
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.
Measured: Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at 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.
Measured: Baseline to Week 28
Change From Baseline to Week 28 in Daily Insulin Dose
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.
Measured: 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
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.
Measured: Baseline to Week 28
Change in Seated Systolic Blood Pressure From 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.
Measured: Baseline to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201429 Aug 2016

First posted1 Sep 2014 (estimated)
Study start6 Sep 2014
Primary completion29 Aug 2016
Study completion29 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02229383
Sponsor's protocol ID: D5553C00002
Other IDs: 2014-003502-33, 2014
Status last verified: Dec 2018
First submitted: 28 Aug 2014
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
PubMed 32306296
Guja C, Frias JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study. Diabetes Obes Metab. 2018 Jul;20(7):1602-1614. doi: 10.1111/dom.13266. Epub 2018 Mar 25.
PubMed 29473704

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02229383
Acronym / sponsor ID: D5553C00002
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Exenatide, Diabetes drug, Treatment efficacy, Placebo, Metabolism, Cardiovascilar metabolic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Sep 2014 (actual)
Primary completion: 29 Aug 2016 (actual)
Study completion: 29 Aug 2016 (actual)
First posted: 1 Sep 2014 (estimated)
Results: Posted 18 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Exenatide	Experimental	Drug: ExenatideExenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Placebo	Placebo comparator	Drug: Exenatide matching placeboPlacebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exenatide2 mg weekly suspension injection	Drug	Exenatide
Exenatide matching placeboOnce weekly Placebo injection	Drug	Placebo

Primary outcome

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.

6 secondary outcomes

Change in Body Weight From Baseline to Week 28
Time frame: 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
Percentage of Participants Achieving HbA1c <7.0% at Week 28
Time frame: Baseline to Week 28
Change From Baseline to Week 28 in Daily Insulin Dose
Time frame: 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
Change in Seated Systolic Blood Pressure From Baseline to Week 28
Time frame: Baseline to Week 28

Results and safety

Results posted to the registry on 18 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide	232	212
Placebo	229	207

Primary outcome: Change in HbA1c From Baseline to Week 28

Time frame: Baseline to Week 28. Least squares mean (95% Confidence Interval). Unit: Percentage of HbA1c

Measure	Exenatide n = 230	Placebo n = 228
Value	-0.96 (-1.12 to -0.81)	-0.22 (-0.38 to -0.07)

Exenatide vs Placebo: Mean Difference (Final Values): -0.74 (95% CI -0.94 to -0.54), p <0.001, Mixed Models Analysis

Population analysed: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline (Day 1) up to Week 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide	11 of 231 (4.8%)	40 of 231 (17.3%)	0 of 231
Placebo	11 of 229 (4.8%)	36 of 229 (15.7%)	1 of 229

Limitations and caveats (from the sponsor): Please note that the data from 4 subjects enrolled at one site were omitted due to potential scientific misconduct at that site. Study conclusions remain unchanged.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32306296Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
Derived from this study: PubMed 29473704Guja C, Frias JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study. Diabetes Obes Metab. 2018 Jul;20(7):1602-1614. doi: 10.1111/dom.13266. Epub 2018 Mar 25.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

123 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide in people with Diabetes Mellitus, run by AstraZeneca at 123 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Hungary, Slovakia, Romania, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 28 (time frame: Baseline to Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02229383, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.