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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229383
Other study ID # D5553C00002
Secondary ID 2014-003502-33
Status Completed
Phase Phase 3
First received
Last updated
Start date September 6, 2014
Est. completion date August 29, 2016

Study information

Verified date December 2018
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 464
Est. completion date August 29, 2016
Est. primary completion date August 29, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Exenatide
2 mg weekly suspension injection
Exenatide matching placebo
Once weekly Placebo injection

Locations

Country Name City State
Hungary Research Site Baja
Hungary Research Site Balatonfured
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Eger
Hungary Research Site Gödöllo
Hungary Research Site Gyula
Hungary Research Site Komárom
Hungary Research Site Létavértes
Hungary Research Site Pécs
Hungary Research Site Satoraljaujhely
Hungary Research Site Szeged
Hungary Research Site Szekszárd
Poland Research Site Lódz
Poland Research Site Lublin
Poland Research Site Lublin
Poland Research Site Oswiecim
Poland Research Site Poznan
Poland Research Site Torun
Poland Research Site Zamosc
Poland Research Site Zgierz
Romania Research Site Baia Mare
Romania Research Site Bucuresti
Romania Research Site Bucuresti
Romania Research Site Bucuresti
Romania Research Site Galati
Romania Research Site Oradea
Romania Research Site Oradea
Romania Research Site Ploiesti
Romania Research Site Tg Mures
Romania Research Site Timi?oara
Slovakia Research Site Bardejov
Slovakia Research Site Bratislava
Slovakia Research Site Bratislava
Slovakia Research Site Dolny Kubin
Slovakia Research Site Kosice
Slovakia Research Site Levice
Slovakia Research Site Levice
Slovakia Research Site Lucenec
Slovakia Research Site Nitra
Slovakia Research Site Nitra
Slovakia Research Site Presov
Slovakia Research Site Sturovo
South Africa Research Site Bloemfontein
South Africa Research Site Kempton Park
South Africa Research Site Krugersdorp
South Africa Research Site Paarl
South Africa Research Site Pretoria
South Africa Research Site Pretoria
South Africa Research Site Somerset West
South Africa Research Site Worcester
United States Research Site Austin Texas
United States Research Site Avon Indiana
United States Research Site Bellevue Nebraska
United States Research Site Birmingham Alabama
United States Research Site Boynton Beach Florida
United States Research Site Brooksville Florida
United States Research Site Chicago Illinois
United States Research Site Chiefland Florida
United States Research Site Chino California
United States Research Site Chula Vista California
United States Research Site Cincinnati Ohio
United States Research Site Clearwater Florida
United States Research Site Cleveland Ohio
United States Research Site Clinton Utah
United States Research Site Columbus Georgia
United States Research Site Coral Gables Florida
United States Research Site Dakota Dunes South Dakota
United States Research Site Dallas Texas
United States Research Site Dallas Texas
United States Research Site Dayton Ohio
United States Research Site El Cajon California
United States Research Site Evansville Indiana
United States Research Site Fort Lauderdale Florida
United States Research Site Franklin Indiana
United States Research Site Fresno California
United States Research Site Greer South Carolina
United States Research Site Haddon Heights New Jersey
United States Research Site Hazelwood Missouri
United States Research Site Hialeah Florida
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Huntsville Alabama
United States Research Site Jacksonville Florida
United States Research Site Jacksonville Florida
United States Research Site Johnson City Tennessee
United States Research Site Kingsport Tennessee
United States Research Site Long Beach California
United States Research Site Los Angeles California
United States Research Site Manassas Virginia
United States Research Site Medford Oregon
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Mission Hills California
United States Research Site Monroe Louisiana
United States Research Site Mooresville North Carolina
United States Research Site Morehead City North Carolina
United States Research Site Morganton North Carolina
United States Research Site Muscle Shoals Alabama
United States Research Site New Orleans Louisiana
United States Research Site Newton Kansas
United States Research Site North Miami Beach Florida
United States Research Site Ogden Utah
United States Research Site Omaha Nebraska
United States Research Site Orlando Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site Port Orchard Washington
United States Research Site Richmond Virginia
United States Research Site Salt Lake City Utah
United States Research Site Spartanburg South Carolina
United States Research Site Tampa Florida
United States Research Site Tempe Arizona
United States Research Site Tustin California
United States Research Site West Hills California

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Romania,  Slovakia,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to Week 28
Secondary 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. Baseline to Week 28
Secondary 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. Baseline to Week 28
Secondary 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. Baseline to Week 28
Secondary 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. Baseline to Week 28
Secondary 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. Baseline to Week 28
Secondary 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. Baseline to Week 28
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