Clinical Trial Details

NCT ID: NCT03235050
Date Last Changed: October 4, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study to evaluate Diabetes Mellitus, Type 2

Research Study Title

A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Purpose

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
AstraZeneca
Duration
12 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Provision of informed consent

  • Male and female subjects aged ≥ 18 years at screening

  • Body mass index between 25 and 45 kg/m2 (inclusive) at screening

  • HbA1c range of 7.0% to 10.5% (inclusive) at screening

  • Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening

  • Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP

Exclusion Criteria:

  • History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures

  • Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening

  • Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

  • Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin within 90 days prior to screening

  • Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening

  • Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract

  • Significant hepatic disease

  • Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening

  • Severely uncontrolled hypertension

  • Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening

  • Severe congestive heart failure

Site Locations (75)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35205 Research Site
United States Arizona Chandler 85224 Research Site
United States Arizona Glendale 85306 Research Site
United States Arizona Glendale 85308 Research Site
United States Arizona Mesa 85213 Research Site
United States Indiana Evansville 47715 Research Site
United States Maryland Elkridge 21075 Research Site
United States Missouri Bridgeton 63044 Research Site
United States New York Brooklyn 11229 Research Site
United States North Carolina Morehead City 28557 Research Site
United States South Carolina Greer 29651 Research Site
United States Texas Houston 77040 Research Site
United States Texas Houston 77074 Research Site
United States Texas Plano 75093 Research Site
United States Virginia Arlington 22206 Research Site
United States Virginia Manassas 20110 Research Site
Canada Alberta Red Deer T4N 6V7 Research Site
Canada Alberta Sherwood Park T8L 0N2 Research Site
Canada Ontario Burlington L7M 4Y1 Research Site
Canada Ontario Etobicoke M9W 4L6 Research Site
Canada Ontario Guelph N1H 1B1 Research Site
Canada Ontario London N5W 6A2 Research Site
Canada Ontario London N6G 5A9 Research Site
Canada Ontario Newmarket L3Y 5G8 Research Site
Canada Ontario Sarnia N7T 4X3 Research Site
Canada Ontario Thornhill L4J 8L7 Research Site
Canada Ontario Toronto M4G 3E8 Research Site
Canada Quebec Levis G6W 0M5 Research Site
Canada Quebec Montreal H4A 3T2 Research Site
Canada Quebec Montreal H4N 2W2 Research Site
Canada Quebec Saint-Marc-des-Carrieres G0A 4B0 Research Site
Czechia Beroun 266 00 Research Site
Czechia Pardubice 530 02 Research Site
Czechia Plzen - Severni Predmesti 301 00 Research Site
Czechia Plzen 301 66 Research Site
Czechia Praha - Klanovice 190 14 Research Site
Czechia Praha 10 Research Site
Czechia Praha 4 140 00 Research Site
Czechia Praha 4 149 00 Research Site
Czechia Praha 140 59 Research Site
Czechia Uherske Hradiste 686 01 Research Site
Germany Aschaffenburg 63739 Research Site
Germany Berlin 10115 Research Site
Germany Berlin 10787 Research Site
Germany Eschweiler 52249 Research Site
Germany Essen 45359 Research Site
Germany Gelnhausen 63571 Research Site
Germany Hof 95028 Research Site
Germany Löhne 32584 Research Site
Germany Magdeburg 39120 Research Site
Germany Mannheim 68163 Research Site
Germany Munster 48145 Research Site
Germany Oldenburg 23758 Research Site
Germany Pirna 01796 Research Site
Germany Rhaunen 55624 Research Site
Russian Federation Chelyabinsk 454091 Research Site
Russian Federation Ekaterinburg 620039 Research Site
Russian Federation Izhevsk 426035 Research Site
Russian Federation Kemerovo 650066 Research Site
Russian Federation Moscow 119034 Research Site
Russian Federation Moscow 119435 Research Site
Russian Federation Perm 614000 Research Site
Russian Federation Perm 614068 Research Site
Russian Federation Saint Petersburg 196601 Research Site
Russian Federation Saint-Petersburg 199226 Research Site
Russian Federation St. Petersburg 196084 Research Site
Russian Federation St.Petersburg 198013 Research Site
Russian Federation Volgograd 400131 Research Site
Slovakia Levice 934 01 Research Site
Slovakia Malacky 901 01 Research Site
Slovakia Roznava 048 01 Research Site
Slovakia Sabinov 083 01 Research Site
Slovakia Trebisov 075 01 Research Site
Slovakia Trencin 911 01 Research Site
Slovakia Trnava 917 01 Research Site

Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
E-mail:

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