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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229396
Other study ID # D5553C00003
Secondary ID 2014-003503-29
Status Completed
Phase Phase 3
First received
Last updated
Start date September 4, 2014
Est. completion date December 28, 2017

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 695
Est. completion date December 28, 2017
Est. primary completion date April 26, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Exantide with Dapagliflozin
2 mg weekly suspension injection and 10 mg Dapagliflozin
Exentide
2 mg
Dapagliflozin
10 mg once daily Dapagliflozin

Locations

Country Name City State
Hungary Research Site Baja
Hungary Research Site Balatonfüred
Hungary Research Site Budaörs
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Eger
Hungary Research Site Godollo
Hungary Research Site Gödöllo
Hungary Research Site Gyula
Hungary Research Site Kecskemét
Hungary Research Site Komárom
Hungary Research Site Létavértes
Hungary Research Site Nyíregyháza
Hungary Research Site Pécs
Hungary Research Site Szeged
Hungary Research Site Szekszárd
Poland Research Site Lodz
Poland Research Site Lódz
Poland Research Site Lublin
Poland Research Site Oswiecim
Poland Research Site Parczew
Poland Research Site Poznan
Poland Research Site Torun
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 Oradea
Romania Research Site Ploiesti
Romania Research Site Timi?oara
Slovakia Research Site Banska Bystrica
Slovakia Research Site Bardejov
Slovakia Research Site Bratislava
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 Pezinok
Slovakia Research Site Sturovo
Slovakia Research Site TrebiĊĦov
South Africa Research Site Bloemfontein
South Africa Research Site Cape Town
South Africa Research Site Johannesburg
South Africa Research Site Kempton Park
South Africa Research Site Middelburg
South Africa Research Site Parow
South Africa Research Site Port Elizabeth
South Africa Research Site Pretoria
United States Research Site Anaheim California
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 Burke Virginia
United States Research Site Burlington North Carolina
United States Research Site Charleston South Carolina
United States Research Site Chicago Illinois
United States Research Site Chula Vista California
United States Research Site Cincinnati Ohio
United States Research Site Clearwater Florida
United States Research Site Clinton Utah
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 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 Glendale Arizona
United States Research Site Greensboro North Carolina
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 Huntsville Alabama
United States Research Site Jacksonville Florida
United States Research Site Jacksonville Florida
United States Research Site La Mesa California
United States Research Site Las Vegas Nevada
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 Memphis Tennessee
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 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 Montclair California
United States Research Site Mooresville North Carolina
United States Research Site Morehead City North Carolina
United States Research Site Muncie Indiana
United States Research Site Newton Kansas
United States Research Site North Miami Beach Florida
United States Research Site Oceanside California
United States Research Site Orlando Florida
United States Research Site Orlando Florida
United States Research Site Pearland Texas
United States Research Site Philadelphia Pennsylvania
United States Research Site Richmond Virginia
United States Research Site Salt Lake City Utah
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site San Diego California
United States Research Site Spartanburg South Carolina
United States Research Site Summerville South Carolina
United States Research Site Tampa Florida
United States Research Site Tempe Arizona
United States Research Site Tomball Texas
United States Research Site Tuscumbia Alabama
United States Research Site Tustin California
United States Research Site Van Nuys California
United States Research Site Vandalia Ohio
United States Research Site Williston Florida

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 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 Change in Body Weight From 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
Secondary Change in Fasting Plasma Glucose From 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
Secondary Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test 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
Secondary Percentage of Patients Achieving Weight Loss =5.0% at 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
Secondary Change in Fasting Plasma Glucose From 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
Secondary Percentage of Patients Achieving HbA1c <7% at 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
Secondary Change in Systolic Blood Pressure From 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
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