DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: Exenatide (Drug); Exenatide matching placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Overall contact:
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy of exenatide in terms of change in Glycosylated hemoglobin (HbA1c)

Secondary outcome:

Efficacy of exenatide in terms of change in body weight

Efficacy of exenatide in terms of change in 2-hour postprandial glucose (PPG) after a standard meal tolerance test

Efficacy of exenatide in terms of proportion of patients with HbA1c <7.0%

Efficacy of exenatide in terms of change in total mean daily insulin dose

Efficacy of exenatide in terms of proportion of patients with HbA1c <7.0% at Week 28 with no weight gain at Week 28 and no severe hypoglycemia

Efficacy of exenatide in terms of change in systolic blood pressure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com

Research Site, Baja, Hungary; Recruiting

Research Site, Balatonfured, Hungary; Recruiting

Research Site, Budapest, Hungary; Recruiting

Research Site, Budapest, Hungary; Not yet recruiting

Research Site, Debrecen, Hungary; Not yet recruiting

Research Site, Eger, Hungary; Recruiting

Research Site, Gyula, Hungary; Recruiting

Research Site, Gödöllő, Hungary; Recruiting

Research Site, Kecskemét, Hungary; Not yet recruiting

Research Site, Komárom, Hungary; Recruiting

Research Site, Létavértes, Hungary; Recruiting

Research Site, Pécs, Hungary; Recruiting

Research Site, Satoraljaujhely, Hungary; Recruiting

Research Site, Szeged, Hungary; Recruiting

Research Site, Szekszárd, Hungary; Recruiting

Research Site, Székesfehérvár, Hungary; Not yet recruiting

Research Site, Lublin, Poland; Recruiting

Research Site, Oświęcim, Poland; Recruiting

Research Site, Poznań, Poland; Recruiting

Research Site, Torun, Poland; Recruiting

Research Site, Zamość, Poland; Recruiting

Research Site, Zgierz, Poland; Recruiting

Research Site, Łódź, Poland; Recruiting

Research Site, Baia Mare, Romania; Not yet recruiting

Research Site, Bucuresti, Romania; Not yet recruiting

Research Site, Galati, Romania; Not yet recruiting

Research Site, Oradea, Romania; Not yet recruiting

Research Site, Ploiesti, Romania; Not yet recruiting

Research Site, Tg Mures, Romania; Not yet recruiting

Research Site, Timișoara, Romania; Not yet recruiting

Research Site, Bardejov, Slovakia; Recruiting

Research Site, Bratislava, Slovakia; Recruiting

Research Site, Dolny Kubin, Slovakia; Recruiting

Research Site, Kosice, Slovakia; Recruiting

Research Site, Levice, Slovakia; Recruiting

Research Site, Lucenec, Slovakia; Recruiting

Research Site, Nitra, Slovakia; Recruiting

Research Site, Presov, Slovakia; Recruiting

Research Site, Sturovo, Slovakia; Recruiting

Research Site, Bloemfontein, South Africa; Recruiting

Research Site, Cape Town, South Africa; Recruiting

Research Site, Kempton Park, South Africa; Recruiting

Research Site, Krugersdorp, South Africa; Recruiting

Research Site, Paarl, South Africa; Recruiting

Research Site, Pretoria, South Africa; Recruiting

Research Site, Worcester, South Africa; Recruiting

Research Site, Birmingham, Alabama, United States; Recruiting

Research Site, Huntsville, Alabama, United States; Recruiting

Research Site, Muscle Shoals, Alabama, United States; Recruiting

Research Site, Tempe, Arizona, United States; Recruiting

Research Site, Chino, California, United States; Recruiting

Research Site, Chula Vista, California, United States; Recruiting

Research Site, El Cajon, California, United States; Recruiting

Research Site, Fresno, California, United States; Recruiting

Research Site, Long Beach, California, United States; Recruiting

Research Site, Los Angeles, California, United States; Recruiting

Research Site, Mission Hills, California, United States; Recruiting

Research Site, San Diego, California, United States; Recruiting

Research Site, Tustin, California, United States; Recruiting

Research Site, West Hills, California, United States; Recruiting

Research Site, Boynton Beach, Florida, United States; Recruiting

Research Site, Bradenton, Florida, United States; Not yet recruiting

Research Site, Brooksville, Florida, United States; Recruiting

Research Site, Chiefland, Florida, United States; Recruiting

Research Site, Clearwater, Florida, United States; Recruiting

Research Site, Coral Gables, Florida, United States; Recruiting

Research Site, Ft Lauderdale, Florida, United States; Recruiting

Research Site, Hialeah, Florida, United States; Recruiting

Research Site, Jacksonville, Florida, United States; Recruiting

Research Site, Miami, Florida, United States; Recruiting

Research Site, North Miami Beach, Florida, United States; Recruiting

Research Site, Orlando, Florida, United States; Not yet recruiting

Research Site, Orlando, Florida, United States; Recruiting

Research Site, Tampa, Florida, United States; Recruiting

Research Site, Columbus, Georgia, United States; Recruiting

Research Site, Chicago, Illinois, United States; Recruiting

Research Site, Avon, Indiana, United States; Recruiting

Research Site, Evansville, Indiana, United States; Recruiting

Research Site, Franklin, Indiana, United States; Recruiting

Research Site, Newton, Kansas, United States; Recruiting

Research Site, Topeka, Kansas, United States; Recruiting

Research Site, Monroe, Louisiana, United States; Recruiting

Research Site, Monroe, Louisiana, United States; Not yet recruiting

Research Site, New Orleans, Louisiana, United States; Not yet recruiting

Research Site, Ann Arbor, Michigan, United States; Not yet recruiting

Research Site, Hazelwood, Missouri, United States; Recruiting

Research Site, Bellevue, Nebraska, United States; Recruiting

Research Site, Omaha, Nebraska, United States; Recruiting

Research Site, Haddon Heights, New Jersey, United States; Recruiting

Research Site, Burlington, North Carolina, United States; Not yet recruiting

Research Site, Greensboro, North Carolina, United States; Recruiting

Research Site, Mooresville, North Carolina, United States; Recruiting

Research Site, Morehead City, North Carolina, United States; Recruiting

Research Site, Morganton, North Carolina, United States; Recruiting

Research Site, Cincinnati, Ohio, United States; Recruiting

Research Site, Cleveland, Ohio, United States; Recruiting

Research Site, Dayton, Ohio, United States; Recruiting

Research Site, Medford, Oregon, United States; Recruiting

Research Site, Philadelphia, Pennsylvania, United States; Recruiting

Research Site, Charleston, South Carolina, United States; Not yet recruiting

Research Site, Greer, South Carolina, United States; Recruiting

Research Site, Spartanburg, South Carolina, United States; Recruiting

Research Site, Dakota Dunes, South Dakota, United States; Recruiting

Research Site, Johnson City, Tennessee, United States; Recruiting

Research Site, Kingsport, Tennessee, United States; Recruiting

Research Site, Memphis, Tennessee, United States; Not yet recruiting

Research Site, Austin, Texas, United States; Recruiting

Research Site, Dallas, Texas, United States; Recruiting

Research Site, Houston, Texas, United States; Recruiting

Research Site, Clinton, Utah, United States; Recruiting

Research Site, Ogden, Utah, United States; Recruiting

Research Site, Salt Lake City, Utah, United States; Recruiting

Research Site, Manassas, Virginia, United States; Recruiting

Research Site, Richmond, Virginia, United States; Recruiting

Research Site, Port Orchard, Washington, United States; Recruiting

Research Site, Spokane, Washington, United States; Not yet recruiting

Additional Information

Starting date: September 2014
Last updated: July 15, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017