Clinical trial NCT02229383: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Exenatide
Diabetes drug
Treatment efficacy
Placebo
Metabolism
Cardiovascilar metabolic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-09-01
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 28
timeFrame: Baseline to Week 28
Secondary outcomes:
measure: Change in Body Weight From Baseline to Week 28
timeFrame: Baseline to Week 28
measure: Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
timeFrame: Baseline to Week 28
measure: Percentage of Participants Achieving HbA1c <7.0% at Week 28
timeFrame: Baseline to Week 28
measure: Change From Baseline to Week 28 in Daily Insulin Dose
timeFrame: Baseline to Week 28
measure: Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
timeFrame: Baseline to Week 28
measure: Change in Seated Systolic Blood Pressure From Baseline to Week 28
timeFrame: Baseline to Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Research Site
state: Alabama
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Chino
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: El Cajon
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Hills
country: United States
facility: Research Site
state: California
city: Tustin
country: United States
facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Brooksville
country: United States
facility: Research Site
state: Florida
city: Chiefland
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Fort Lauderdale
country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: North Miami Beach
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
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state: Florida
city: Columbus
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state: Georgia
city: Chicago
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state: Illinois
city: Avon
country: United States
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state: Indiana
city: Evansville
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facility: Research Site
state: Indiana
city: Franklin
country: United States
facility: Research Site
state: Indiana
city: Newton
country: United States
facility: Research Site
state: Kansas
city: Monroe
country: United States
facility: Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Hazelwood
country: United States
facility: Research Site
state: Missouri
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Haddon Heights
country: United States
facility: Research Site
state: New Jersey
city: Mooresville
country: United States
facility: Research Site
state: North Carolina
city: Morehead City
country: United States
facility: Research Site
state: North Carolina
city: Morganton
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
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state: Pennsylvania
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
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state: South Carolina
city: Dakota Dunes
country: United States
facility: Research Site
state: South Dakota
city: Johnson City
country: United States
facility: Research Site
state: Tennessee
city: Kingsport
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Clinton
country: United States
facility: Research Site
state: Utah
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Port Orchard
country: United States
facility: Research Site
state: Washington
city: Baja
country: Hungary
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Gödöllő
country: Hungary
facility: Research Site
city: Komárom
country: Hungary
facility: Research Site
city: Létavértes
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Satoraljaujhely
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szekszárd
country: Hungary
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Oświęcim
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Zamość
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Tg Mures
country: Romania
facility: Research Site
city: Timișoara
country: Romania
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Sturovo
country: Slovakia
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Kempton Park
country: South Africa
facility: Research Site
city: Krugersdorp
country: South Africa
facility: Research Site
city: Paarl
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Somerset West
country: South Africa
facility: Research Site
city: Worcester
country: South Africa
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.