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Completed

NCT Number: NCT03235050

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Botevgrad, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI0382 low dose

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

MEDI0382 mid dose

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

MEDI0382 high dose

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

Placebo

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

liraglutide

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

Primary outcomes

  1. Change in HbA1c

    Time frame: From baseline to 14 weeks

    To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo

  2. Percent Change in Body Weight

    Time frame: From baseline to 14 weeks

    To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo

Secondary outcomes

  1. Change in HbA1c

    Time frame: from baseline to 26 weeks and 54 weeks

    To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo

  2. Percentage of Participants Achieving an HbA1c Target < 7.0%

    Time frame: after 14, 26, and 54 weeks

    To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of <7% versus placebo

  3. Percent Change in Body Weight

    Time frame: from baseline to 26 weeks and 54 weeks

    To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo

  4. Absolute Change in Body Weight

    Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks

    To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo

  5. Percent Change in Body Weight Versus Active Comparator

    Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks

    To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily

  6. Absolute Change in Body Weight Versus Active Comparator

    Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks

    To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily

  7. Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%

    Time frame: after 14 weeks, 26 weeks and 54 weeks

    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

  8. Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control

    Time frame: at 14 weeks, 26 weeks and 54 weeks

    To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo

  9. Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)

    Time frame: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54

    To characterise the PK profile of 100, 200, and 300 μg of cotadutide

  10. Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)

    Time frame: Baseline through 54-week treatment period and 28-day follow-up

    To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide

  11. Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants

    Time frame: Baseline through 54-week treatment period and 28-day follow-up

    To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • MedImmune LLC

Registry information

Official 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 1, 2017
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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