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A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03235050
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Brief 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: MEDI0382 low dose Drug: MEDI0382 mid dose Drug: MEDI0382 high dose Drug: Placebo Drug: Liraglutide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 834 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The study will be conducted in a double-blind fashion for MEDI0382 and placebo. The sponsor staff, the subjects, and the Investigators involved in the treatment of subjects or in the clinical evaluation of subjects will not be aware of the treatment received. Liraglutide will be provided in an open-label active comparator arm.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDI0382 low dose + Metformin
Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: MEDI0382 low dose
Pharmaceutical form: solution Route of administration: subcutaneous

Experimental: MEDI0382 mid dose + Metformin
Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: MEDI0382 mid dose
Pharmaceutical form: solution Route of administration: subcutaneous

Experimental: MEDI0382 high dose + Metformin
Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: MEDI0382 high dose
Pharmaceutical form: solution Route of administration: subcutaneous

Placebo Comparator: Placebo + Metformin
Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: Placebo
Pharmaceutical form: solution Route of administration: subcutaneous

Active Comparator: Liraglutide + Metformin
Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: Liraglutide
Pharmaceutical form: solution Route of administration: subcutaneous




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From baseline to 14 weeks ]
  2. Percent change in body weight [ Time Frame: From baseline to 14 weeks ]

Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: from baseline to 26 weeks and 54 weeks ]
  2. Percentage of subjects achieving an HbA1c target < 7.0% [ Time Frame: after 14 weeks, 26 weeks and 54 weeks ]
  3. Percent change in body weight [ Time Frame: from baseline to 26 weeks and 54 weeks ]
  4. Absolute change in body weight [ Time Frame: from baseline to 14 weeks, 26 weeks and 54 weeks ]
  5. Percentage of subjects achieving weight loss of ≥5% and ≥10% [ Time Frame: after 14 weeks, 26 weeks and 54 weeks ]
  6. Proportion of subjects rescued or discontinued for lack of glycaemic control [ Time Frame: at 14 weeks, 26 weeks and 54 weeks ]
  7. Percent and absolute change in body weight versus active comparator [ Time Frame: from baseline to 14 weeks, 26 weeks and 54 weeks ]
  8. Pharmacokinetic (PK) endpoint: Trough plasma concentration (Cmin) [ Time Frame: during dosing and follow-up (minimum 54 weeks) ]
  9. Pharmacokinetic (PK) endpoint: Development of antidrug antibodies and titre (if positive) [ Time Frame: during dosing and follow-up (minimum 54 weeks) ]

Other Outcome Measures:
  1. Assessment of vital signs, laboratory test results and adverse events (AE) as measures of safety and tolerability of MEDI0382 [ Time Frame: during treatment and follow-up (minimum 54 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235050


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Sponsors and Collaborators
AstraZeneca
MedImmune LLC

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03235050     History of Changes
Other Study ID Numbers: D5670C00004
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists