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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03235050
Other study ID # D5670C00004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2, 2017
Est. completion date June 14, 2019

Study information

Verified date July 2020
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 834
Est. completion date June 14, 2019
Est. primary completion date May 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria:

- Provision of informed consent

- Male and female subjects aged = 18 years at screening

- Body mass index = 25 kg/m2 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. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable

- 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 for a period longer than 2 weeks 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MEDI0382 low dose
Pharmaceutical form: solution Route of administration: subcutaneous
MEDI0382 mid dose
Pharmaceutical form: solution Route of administration: subcutaneous
MEDI0382 high dose
Pharmaceutical form: solution Route of administration: subcutaneous
Placebo
Pharmaceutical form: solution Route of administration: subcutaneous
Liraglutide
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country Name City State
Bulgaria Research Site Botevgrad
Bulgaria Research Site Kozloduy
Bulgaria Research Site Kyustendil
Bulgaria Research Site Lukovit
Bulgaria Research Site Petrich
Bulgaria Research Site Pleven
Bulgaria Research Site Plovdiv
Bulgaria Research Site Russe
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Stara Zagora
Canada Research Site Burlington Ontario
Canada Research Site Etobicoke Ontario
Canada Research Site Guelph Ontario
Canada Research Site Levis Quebec
Canada Research Site London Ontario
Canada Research Site London Ontario
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Newmarket Ontario
Canada Research Site Red Deer Alberta
Canada Research Site Saint-Marc-des-Carrieres Quebec
Canada Research Site Sarnia Ontario
Canada Research Site Sherwood Park Alberta
Canada Research Site Thornhill Ontario
Canada Research Site Toronto Ontario
Czechia Research Site Beroun
Czechia Research Site Jilove u Prahy
Czechia Research Site Pardubice
Czechia Research Site Plzen
Czechia Research Site Plzen - Severni Predmesti
Czechia Research Site Praha
Czechia Research Site Praha - Klanovice
Czechia Research Site Praha 10
Czechia Research Site Praha 4
Czechia Research Site Praha 4
Czechia Research Site Uherske Hradiste
Germany Research Site Aschaffenburg
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Eschweiler
Germany Research Site Essen
Germany Research Site Essen
Germany Research Site Gelnhausen
Germany Research Site Hamburg
Germany Research Site Hamburg
Germany Research Site Hof
Germany Research Site Löhne
Germany Research Site Lübeck
Germany Research Site Magdeburg
Germany Research Site Mannheim
Germany Research Site Munster
Germany Research Site Oldenburg
Germany Research Site Pirna
Germany Research Site Rhaunen
Germany Research Site Villingen-Schwenningen
Mexico Research Site Guadalajara
Mexico Research Site México
Mexico Research Site México
Mexico Research Site Monterrey
Mexico Research Site Veracruz
Mexico Research Site Veracruz
Russian Federation Research Site Chelyabinsk
Russian Federation Research Site Ekaterinburg
Russian Federation Research Site Izhevsk
Russian Federation Research Site Kemerovo
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Perm
Russian Federation Research Site Perm
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint-Petersburg
Russian Federation Research Site St. Petersburg
Russian Federation Research Site St.Petersburg
Russian Federation Research Site Vladikavkaz
Russian Federation Research Site Volgograd
Slovakia Research Site Banska Bystrica
Slovakia Research Site Bratislava
Slovakia Research Site Dolny Kubin
Slovakia Research Site Levice
Slovakia Research Site Lucenec
Slovakia Research Site Malacky
Slovakia Research Site Namestovo
Slovakia Research Site Nitra
Slovakia Research Site Nove Mesto nad Vahom
Slovakia Research Site Prievidza
Slovakia Research Site Rimavska Sobota
Slovakia Research Site Roznava
Slovakia Research Site Sabinov
Slovakia Research Site Trebisov
Slovakia Research Site Trencin
Slovakia Research Site Trnava
Slovakia Research Site Zilina
United States Research Site Arlington Virginia
United States Research Site Baton Rouge Louisiana
United States Research Site Birmingham Alabama
United States Research Site Bridgeton Missouri
United States Research Site Brooklyn New York
United States Research Site Chandler Arizona
United States Research Site Elkridge Maryland
United States Research Site Evansville Indiana
United States Research Site Glendale Arizona
United States Research Site Glendale Arizona
United States Research Site Greer South Carolina
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Las Vegas Nevada
United States Research Site Layton Utah
United States Research Site Manassas Virginia
United States Research Site Marietta Georgia
United States Research Site Mesa Arizona
United States Research Site Metairie Louisiana
United States Research Site Morehead City North Carolina
United States Research Site Philadelphia Pennsylvania
United States Research Site Plano Texas

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca MedImmune LLC

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Germany,  Mexico,  Russian Federation,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c To assess the effect of 100, 200, 300 µg of cotadutide on HbA1c versus placebo From baseline to 14 weeks
Primary Percent Change in Body Weight To assess the effect of 100, 200, 300 µg of cotadutide on body weight versus placebo From baseline to 14 weeks
Secondary Change in HbA1c To assess the effect of 100, 200, 300 µg of cotadutide on HbA1c versus placebo from baseline to 26 weeks and 54 weeks
Secondary Percentage of Participants Achieving an HbA1c Target < 7.0% To assess the effect of 100, 200, and 300 µg of cotadutide on percentage of participants achieving an HbA1c target of <7% versus placebo after 14, 26, and 54 weeks
Secondary Percent Change in Body Weight To assess the effect of 100, 200, and 300 µg of cotadutide on body weight versus placebo from baseline to 26 weeks and 54 weeks
Secondary Absolute Change in Body Weight To assess the effect of 100, 200, 300 µg of cotadutide on body weight versus placebo from baseline to 14 weeks, 26 weeks and 54 weeks
Secondary Percent Change in Body Weight Versus Active Comparator To assess the effect of 100, 200, and 300 µg of cotadutide on body weight versus liraglutide 1.8 mg once daily from baseline to 14 weeks, 26 weeks and 54 weeks
Secondary Absolute Change in Body Weight Versus Active Comparator To assess the effect of 100, 200, and 300 µg of cotadutide on body weight versus liraglutide 1.8 mg once daily from baseline to 14 weeks, 26 weeks and 54 weeks
Secondary Percentage of Participants Achieving Weight Loss of =5% and =10% To assess the effect of 100, 200, and 300 µg of cotadutide on percentage of subjects achieving weight loss of =5% and =10% versus placebo after 14 weeks, 26 weeks and 54 weeks
Secondary Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control To assess the effect of 100, 200, and 300 µg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo at 14 weeks, 26 weeks and 54 weeks
Secondary Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) To characterise the PK profile of 100, 200, and 300 µg of cotadutide Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
Secondary Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) To characterise the immunogenicity of 100, 200, and 300 µg of cotadutide Baseline through 54-week treatment period and 28-day follow-up
Secondary Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants To characterise the immunogenicity of 100, 200, and 300 µg of cotadutide Baseline through 54-week treatment period and 28-day follow-up
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