Type 2 Diabetes MellitusPhase 2NCT03745937

A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing MEDI0382 in people with Type 2 Diabetes Mellitus, run by MedImmune LLC at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 2a, randomized, blinded, placebo-controlled study in up to 20 overweight or obese participants with type 2 diabetes mellitus. The participants will participate in the study for approximately 18 weeks, including screening, run-in and treatment periods and a safety follow-up. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MEDI0382
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteGermany
Study dates: 7 Jan 2019to 28 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants aged 18 to 74 years (inclusive) at screening.
Provision of signed and dated written informed consent (with the exception of consent for genetic and non-genetic research) prior to any study specific procedures.
Body mass index (BMI) between 27 and 35 kg/m^2 (inclusive) at screening.
Hemoglobin A1c (HbA1c) range of 6.5% to 8.5% (inclusive) at screening (Note: Participants may be re-tested for the HbA1c entry criterion only once.).
Willing and able to self-inject study drug for the duration of the study.
Diagnosed with type 2 diabetes mellitus with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease >= 500 mg/day) has occurred in the three months prior to screening.
Female participants must have a negative pregnancy test at screening and randomization, and must not be lactating.
Female participants of childbearing potential who are sexually active with a male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of study drug.

Who cannot join

History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures during the run-in period.
Any participant who has received another study drug as part of a clinical study or a glucagon-like peptide-1 (GLP-1) analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
Concurrent participation in another study of any kind and repeat randomization in this study is prohibited.
Any participant who has received any of the following medications prior to the start of the study:
Herbal preparations or drugs licensed for control of body weight or appetite
Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying

Show all 37Show fewer

Antimicrobials within the quinolone, macrolide or azole class
Any change in antihypertensive medication
Aspirin (acetylsalicylic acid)
Paracetamol (acetaminophen) or paracetamol-containing preparations
Ascorbic acid (vitamin C) supplements
Severe allergy/hypersensitivity to any of the proposed study treatments, standardized meals, or excipients.
Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the participant has been treated with daily SC insulin within 90 days prior to screening.
Acute pancreatitis, pancreatic amylase, and/or pancreatic lipase > 3 × upper limit of normal range (ULN); history of chronic pancreatitis; or serum triglyceride levels > 11 mmol/L (1000 mg/dL) at screening.
Significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures), which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
Significant hepatic disease (except for nonalcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
Aspartate transaminase (AST) >= 3 × ULN
Alanine transaminase (ALT) >= 3 × ULN
Total bilirubin (TBL) >= 2 × ULN
Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73m^2 at screening.
Poorly controlled hypertension defined as:
Systolic blood pressure (BP) > 160 mm Hg
Diastolic BP or >= 90 mm Hg
Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes.
Prolonged QT intervals corrected for heart rate or family history of long QT-segment at screening.
PR (PQ) interval prolongation, intermittent second or third-degree atrioventricular (AV) block, or AV dissociation.
Persistent or intermittent complete bundle branch block.
Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening.
Severe congestive heart failure.
Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
Hemoglobinopathy, hemolytic anemia or chronic anemia or any other condition known to interfere with the interpretation of HbA1c measurement.
History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer.
Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
History of substance dependence, alcohol abuse, or excessive alcohol intake. Participants who use benzodiazepines for chronic anxiety or sleep disorders may be permitted to enter the study.
Symptoms of depression or any other psychiatric disorder requiring treatment with medication.
History of severe allergy/hypersensitivity, including to any component of the investigational product formulation or other biological agent, or ongoing clinically important allergy/hypersensitivity.
Blood/plasma donation within 1 month of screening.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Neuss, 41460

Other trials in Germany

About this study

Official title: A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MEDI0382 in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: MEDI0382, Placebo
Keywords: MEDI0382, diabetes, obesity, overweight, type 2 diabetes mellitus
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI0382Drug
Subcutaneous dose of MEDI0382 will be up-titrated weekly once daily up to 8 weeks during the uptitration period and thereafter once daily in 3-week TEP.
PlaceboDrug
Subcutaneous dose of placebo matched to MEDI0382 will be administered once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.

Study groups in NCT03745937
Study group	Role	What they receive
MEDI0382 Cohort 1	Experimental	Participants will receive subcutaneous (SC) dose of MEDI0382 uptitrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week treatment extension period (TEP). Receives: Drug: MEDI0382
Placebo Cohort 1	Placebo comparator	Participants will receive SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the uptitration period and thereafter once daily through 3 week TEP. Receives: Drug: Placebo
MEDI0382 Cohort 2	Experimental	Participants will receive SC dose of MEDI0382 uptitrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP. Receives: Drug: MEDI0382
Placebo Cohort 2	Placebo comparator	Participants will receive SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of Participants With TEAEs and TESAEs Through the End of the Follow-up Period
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration Period
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG.
Measured: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up Period
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG.
Measured: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Up-titration Period
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate).
Measured: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Follow-up Period
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate).
Measured: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Up-titration Period
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and, endocrine.
Measured: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Follow-up Period
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examination findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and endocrine.
Measured: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Up-titration Period
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Measured: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Follow-up Period
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Measured: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)

Secondary outcomes (20)

Area Under the Plasma Concentration Time Curve Over a Dosing Interval (AUCτ) of MEDI0382
Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 is reported.
Measured: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Maximum Observed Serum Concentration (Cmax) of MEDI0382
Maximum observed serum concentration (Cmax) of MEDI0382 is reported.
Measured: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382
Time to observed maximum serum concentration (Tmax) of MEDI0382 is reported.
Measured: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Trough Plasma Concentration (Ctrough) of MEDI0382
Trough concentration is the lowest concentration reached by a drug before the next dose is administered. Trough plasma concentration (Ctrough) of MEDI0382 is reported.
Measured: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Observed Accumulation Ratio (Ro) of MEDI0382 Calculated Using AUC
The Ro was calculated using the AUC method which account for the overall exposure measured using the Day 1 and specified time point (Day I). Ro = AUCtrough [Day I]/AUCtrough [Day 1]; where I is the specified day.
Measured: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382 Treatment
Number of participants with positive ADA to MEDI0382 are reported.
Measured: Pre-dose (Day -2), Days 7, 14, 35, 42, 56; Day 21 of 3 week treatment extension, and 28 days post last dose (approximately 5 months)
Change From Baseline in Daily (24 Hours) Average Glucose Levels Over Time as Measured by Continuous Glucose Monitoring (CGM)
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. During 14 days follow-up (Day 91), last observation carried forward (LOCF) approach was used to calculate the value.
Measured: Baseline (Day -1) through Day 56 (end of the up-titration period), Day 77 (end of the treatment extension period) and Day 91 (end of the follow-up period)
Change From Baseline in 7-day Average Glucose Levels Over Time as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level.
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Percentage Change From Baseline in Glucose Area Under Concentration Time-curve Over 4 Hours (AUC4Hrs) During a Standardized Breakfast, Lunch, and Evening Meal Over Time as Measured by CGM
Change from baseline in percentage of glucose AUC4Hrs during a standardized breakfast, lunch, and evening meal over time is reported. Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level.
Measured: Baseline (Day -1) through Day 7 (end of Week 1), Day 56 (end of the up-titration period), and Day 77 (end of the treatment extension period)
Change From Baseline in Coefficient of Variation (CV) in Glucose Over 7 Days as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. Change from baseline in coefficient of variation in glucose over 7 days is reported.
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 24 Hours Time as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. Hyperglycemia (> 140 mg/dL), normoglycemia (70 -140 mg/dL), and clinically significant hypoglycemia (< 54 mg/dL).
Measured: Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)
Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 7 Days as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Data derived from CGM was used to calculate the average glucose level over 24-hour and 7-day periods to compare the glucose lowering efficacy of each dose level. Hyperglycemia (> 140 mg/dL), normoglycemia (70 -140 mg/dL), and clinically significant hypoglycemia (< 54 mg/dL).
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Change From Baseline in Estimated Hemoglobin A1c (HbA1c) Based on 7-day CGM Glucose Over Time
Change from baseline in estimated HbA1c based on 7-day glucose over time is reported.
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Change From Baseline in Fasting Plasma Glucose Over Time
Change from baseline in fasting plasma glucose over time is reported. During the Day 21, and Day 28, LOCF approach was used to calculate the value.
Measured: Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)
Change From Baseline in HbA1c
Change from baseline in HbA1c is reported.
Measured: Baseline (Day -1) through Day 77 (end of the treatment extension period)
Absolute Change From Baseline in Body Weight
Absolute change from baseline in body weight is reported.
Measured: Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)
Percentage Change From Baseline in Body Weight
Percentage change from baseline in body weight is reported.
Measured: Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)
Absolute Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period
Absolute change from baseline in body weight to the end of each week of the up-titration period is reported.
Measured: Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56
Percentage Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period
Percentage change from baseline in body weight to the end of each week of the up-titration period is reported.
Measured: Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56
Percentage of Participants Achieving Greater Than 5% Body Weight Loss From Baseline to the End of the Treatment Extension Period
Percentage of participants achieving greater than 5% body weight loss from baseline is reported.
Measured: Baseline (Day -1) through Day 77 (end of the treatment extension period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 201928 May 2019

First posted19 Nov 2018
Study start7 Jan 2019
Primary completion28 May 2019
Study completion28 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03745937
Sponsor's protocol ID: D5670C00030
Status last verified: May 2020
First submitted: 8 Nov 2018
Last updated: 5 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MEDI0382 in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03745937
Acronym / sponsor ID: D5670C00030
Conditions: Type 2 Diabetes Mellitus
Keywords: MEDI0382, diabetes, obesity, overweight, type 2 diabetes mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 7 Jan 2019 (actual)
Primary completion: 28 May 2019 (actual)
Study completion: 28 May 2019 (actual)
First posted: 19 Nov 2018 (actual)
Results: Posted 5 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
MEDI0382 Cohort 1	Experimental	Drug: MEDI0382Participants will receive subcutaneous (SC) dose of MEDI0382 uptitrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week treatment extension period (TEP).
Placebo Cohort 1	Placebo comparator	Drug: PlaceboParticipants will receive SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the uptitration period and thereafter once daily through 3 week TEP.
MEDI0382 Cohort 2	Experimental	Drug: MEDI0382Participants will receive SC dose of MEDI0382 uptitrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
Placebo Cohort 2	Placebo comparator	Drug: PlaceboParticipants will receive SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants aged 18 to 74 years (inclusive) at screening.
Provision of signed and dated written informed consent (with the exception of consent for genetic and non-genetic research) prior to any study specific procedures.
Body mass index (BMI) between 27 and 35 kg/m^2 (inclusive) at screening.
Hemoglobin A1c (HbA1c) range of 6.5% to 8.5% (inclusive) at screening (Note: Participants may be re-tested for the HbA1c entry criterion only once.).
Willing and able to self-inject study drug for the duration of the study.

Key exclusion criteria (37 listed)

History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures during the run-in period.
Any participant who has received another study drug as part of a clinical study or a glucagon-like peptide-1 (GLP-1) analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
Concurrent participation in another study of any kind and repeat randomization in this study is prohibited.
Any participant who has received any of the following medications prior to the start of the study:
Severe allergy/hypersensitivity to any of the proposed study treatments, standardized meals, or excipients.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI0382Subcutaneous dose of MEDI0382 will be up-titrated weekly once daily up to 8 weeks during the uptitration period and thereafter once daily in 3-week TEP.	Drug	MEDI0382 Cohort 1, MEDI0382 Cohort 2
PlaceboSubcutaneous dose of placebo matched to MEDI0382 will be administered once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.	Drug	Placebo Cohort 1, Placebo Cohort 2

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period
Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With TEAEs and TESAEs Through the End of the Follow-up Period
Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration Period
Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG.
Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up Period
Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals from the primary lead of the digital 12-lead ECG.
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Up-titration Period
Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate).
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Follow-up Period
Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate).
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Up-titration Period
Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and, endocrine.
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Follow-up Period
Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examination findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and endocrine.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Up-titration Period
Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period)
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Follow-up Period
Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.

20 secondary outcomes

Area Under the Plasma Concentration Time Curve Over a Dosing Interval (AUCτ) of MEDI0382
Time frame: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Maximum Observed Serum Concentration (Cmax) of MEDI0382
Time frame: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382
Time frame: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Trough Plasma Concentration (Ctrough) of MEDI0382
Time frame: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Observed Accumulation Ratio (Ro) of MEDI0382 Calculated Using AUC
Time frame: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382 Treatment
Time frame: Pre-dose (Day -2), Days 7, 14, 35, 42, 56; Day 21 of 3 week treatment extension, and 28 days post last dose (approximately 5 months)
Change From Baseline in Daily (24 Hours) Average Glucose Levels Over Time as Measured by Continuous Glucose Monitoring (CGM)
Time frame: Baseline (Day -1) through Day 56 (end of the up-titration period), Day 77 (end of the treatment extension period) and Day 91 (end of the follow-up period)
Change From Baseline in 7-day Average Glucose Levels Over Time as Measured by CGM
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Percentage Change From Baseline in Glucose Area Under Concentration Time-curve Over 4 Hours (AUC4Hrs) During a Standardized Breakfast, Lunch, and Evening Meal Over Time as Measured by CGM
Time frame: Baseline (Day -1) through Day 7 (end of Week 1), Day 56 (end of the up-titration period), and Day 77 (end of the treatment extension period)
Change From Baseline in Coefficient of Variation (CV) in Glucose Over 7 Days as Measured by CGM
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 24 Hours Time as Measured by CGM
Time frame: Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)
Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 7 Days as Measured by CGM
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Change From Baseline in Estimated Hemoglobin A1c (HbA1c) Based on 7-day CGM Glucose Over Time
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
Change From Baseline in Fasting Plasma Glucose Over Time
Time frame: Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)
Change From Baseline in HbA1c
Time frame: Baseline (Day -1) through Day 77 (end of the treatment extension period)
Absolute Change From Baseline in Body Weight
Time frame: Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)
Percentage Change From Baseline in Body Weight
Time frame: Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)
Absolute Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period
Time frame: Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56
Percentage Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period
Time frame: Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56
Percentage of Participants Achieving Greater Than 5% Body Weight Loss From Baseline to the End of the Treatment Extension Period
Time frame: Baseline (Day -1) through Day 77 (end of the treatment extension period)

Results and safety

Results posted to the registry on 5 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Cohort 1	2	2
MEDI0382 Cohort 1	6	5
Placebo Cohort 2	3	3
MEDI0382 Cohort 2	9	7

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period

Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period). Count of participants. Unit: Participants

Measure	Placebo Cohort 1 n = 2	MEDI0382 Cohort 1 n = 6	Placebo Cohort 2 n = 3	MEDI0382 Cohort 2 n = 9
TEAEs	2	6	3	8
TESAEs	0	0	0	0

Population analysed: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Primary outcome: Number of Participants With TEAEs and TESAEs Through the End of the Follow-up Period

Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months). Count of participants. Unit: Participants

Measure	Placebo Cohort 1 n = 2	MEDI0382 Cohort 1 n = 6	Placebo Cohort 2 n = 3	MEDI0382 Cohort 2 n = 9
TEAEs	2	6	3	8
TESAEs	0	0	0	0

Population analysed: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Primary outcome: Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration Period

Time frame: Baseline (Day -1) through Day 56 (end of Up-titration period). Count of participants. Unit: Participants

Measure	Placebo Cohort 1 n = 2	MEDI0382 Cohort 2 n = 9
Atrial fibrillation	0	1
Supraventricular extrasystoles	0	1
Ventricular extrasystoles	0	1
Ventricular tachycardia	1	0

Population analysed: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Primary outcome: Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up Period

Time frame: Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months). Count of participants. Unit: Participants

Measure	Placebo Cohort 1 n = 2	MEDI0382 Cohort 2 n = 9
Atrial fibrillation	0	1
Supraventricular extrasystoles	0	1
Ventricular extrasystoles	0	1
Ventricular tachycardia	1	0

Population analysed: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day -1) through 28 days post last dose (approximately up to 5 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Cohort 1	0 of 2 (0%)	2 of 2 (100%)	0 of 2
MEDI0382 Cohort 1	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Placebo Cohort 2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
MEDI0382 Cohort 2	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSP redacted protocolLink provided by the sponsor.
SAP redactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tim Heise, MD principal investigator

Profil Institut für Stoffwechselforschung GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI0382 in people with Type 2 Diabetes Mellitus, run by MedImmune LLC at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period (time frame: Baseline (Day -1) through Day 56 (end of Up-titration period)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03745937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.