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A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02548585
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MEDI0382 Drug: Placebo Phase 1 Phase 2

Detailed Description:
This is a randomized, double-blind, placebo controlled study designed to evaluate the efficacy, safety, and PK of MEDI0382 administered as multiple daily SC doses to subjects with T2DM. Approximately one hundred and seven subjects will be enrolled across 6 cohorts. In cohorts 1-3 the subjects will be randomized to MEDI0382 or placebo (3:1). In Cohort 4, subjects will be randomized 1:1. In cohort 5 and 6 subjects will be randomized to MEDI0382 or placebo (3:1).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects With a History of Type 2 Diabetes Mellitus
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : February 24, 2017
Actual Study Completion Date : February 24, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDI0382
MEDI0382 administered subcutaneously
Drug: MEDI0382
MEDI0382 administered subcutaneously

Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo
Placebo administered subcutaneously




Primary Outcome Measures :
  1. Percent change from baseline in MMT glucose AUC (up to 240 minutes post MMT) to end of treatment (Cohort 4 only) [ Time Frame: 42 days post dosing ]
    Percent change from baseline in MMT glucose AUC (up to 240 minutes post MMT) to end of treatment (Cohort 4 only)

  2. Change from baseline in body weight in kg to end of treatment (Cohort 4 only) [ Time Frame: 42 days post dosing ]
    Change from baseline in body weight in kg to end of treatment (Cohort 4 only)


Secondary Outcome Measures :
  1. Change from baseline in HbA1c to end of treatment [ Time Frame: 42 days post dosing ]
    Change from baseline in HbA1c to end of treatment

  2. Change from baseline in fructosamine to end of treatment [ Time Frame: 42 days post dosing ]
    Change from baseline in fructosamine to end of treatment

  3. Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  4. Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

  5. Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

  6. Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

  7. Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Physical examination

  8. Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax) [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)

  9. Pharmacokinetics of MEDI0382, time to maximum observed plasma drug concentration (Tmax) [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Pharmacokinetics of MEDI0382, time to maximum observed plasma drug concentration (Tmax)

  10. Pharmacokinetics of MEDI0382, area under the curve concentration (AUC) [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)

  11. Proportion of subjects with ADA to MEDI0382 [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Proportion of subjects with ADA to MEDI0382

  12. Number of subjects with any suicidal behavior assessed by using Columbia-Suicide Severity Rating Scale (C-SSRS) score during treatment period (Cohort 4) [ Time Frame: 42 days post dosing ]
    Number of subjects with any suicidal behavior assessed by using Columbia-Suicide Severity Rating Scale (C-SSRS) score during treatment period (Cohort 4)

  13. Number of subjects who reported any suicidal ideation assessed by using Columbia-Suicide Severity Rating Scale (C-SSRS) score during treatment period (Cohort 4) [ Time Frame: 42 days post dosing ]
    Number of subjects who reported any suicidal ideation assessed by using Columbia-Suicide Severity Rating Scale (C-SSRS) score during treatment period (Cohort 4)

  14. Change from baseline in body weight in kg to end of treatment [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Change from baseline in body weight in kg to end of treatment

  15. Percent change from baseline in MMT glucose AUC (up to 240 minutes post-MMT) to end of treatment [ Time Frame: Cohort 1: 8 days post dosing Cohort 2: 12 days post dosing Cohort 3: 16 days post dosing Cohort 4: 42 days post dosing Cohort 5: 22 days post dosing Cohort 6: 17 days post dosing ]
    Percent change from baseline in MMT glucose AUC (up to 240 minutes post-MMT) to end of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T2DM, ages 18-65
  • Must provide written informed consent
  • BMI >27 and <40 kg/m2, inclusive
  • Venous access suitable for multiple cannulations
  • Vital signs within normal specified ranges
  • Females must be non-lactating and non-childbearing potential
  • Males must practice 2 effective contraceptive measures if sexually active

Exclusion Criteria:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
  • Any clinically important illness (except for T2DM), medical/surgical procedure, or trauma within 4 weeks prior to dosing
  • Fasting glucose ≥ 200 mg/dL
  • Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
  • Concurrent or previous use of a GLP-1 receptor agonist
  • Current or previous use of systemic corticosteroids within the past 28 days prior to screening
  • Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
  • Known or suspected history of alcohol or drug abuse within the past 3 years.
  • Positive drug screen

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): NCT02548585


Locations
Germany
Research Site
Berlin, Germany, 10117
Research Site
Erfurt, Germany, 99084
Research Site
Kiel, Germany, 24105
Research Site
Leipzig, Germany, 04103
Research Site
Lübeck, Germany, 23538
Research Site
Magdeburg, Germany, 39120
Research Site
Mainz, Germany, 55116
Research Site
Mannheim, Germany, 68167
Research Site
München, Germany, 81241
Research Site
Neu-Ulm, Germany, 89231
Research Site
Neuss, Germany, 41460
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Michael Stumvoll Universitätsklinikum Leipzig

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02548585     History of Changes
Other Study ID Numbers: D5670C00002
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MedImmune LLC:
MEDI0382, diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms