Type 2 Diabetes MellitusPhase 2NCT03244800
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
A Phase 2 study testing MEDI0382 in people with Type 2 Diabetes Mellitus, run by MedImmune LLC at 5 sites in Germany.
Trial summary
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM). Approximately 63 subjects will be enrolled across two cohorts. Read more about this study
- Who is it for?
- Ages 18 to 130 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
- 65 participants
- Where
- 5 sitesGermany
- Study dates
- 4 Sep 2017to 23 Jan 2018
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged ≥ 18 years at screening
- Provision of signed and dated written informed consent
- BMI between 27 and 40 kg/m2
- HbA1c range of 6.5% to 8.5%
- Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred in the 3 months prior to screening
- Subjects prescribed oral dual therapy with a dipeptidyl peptidase-4 inhibitor, sulphonylurea, glitinide, or a sodium-glucose co-transporter 2 inhibitor in addition to metformin at screening may be eligible to enter the study following a 4-week washout period
- Female subjects of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating
- Females of childbearing potential who are sexually active with a nonsterilised male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
Who cannot join
- History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, 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
- Concurrent participation in another study of any kind and repeat randomisation in this study is prohibited
- Severe allergy/hypersensitivity to any of the proposed study treatments
- 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 subject has been treated with daily SC insulin within 90 days prior to screening
- Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper GI 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 non-alcoholic steatohepatitis or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
Show all 22Show fewer
- Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
- Alanine transaminase (ALT) ≥ 3 × ULN
- Total bilirubin ≥ 2 × ULN
- Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73 m2 at screening (GFR estimated according to Modification of Diet in Renal Disease [MDRD] using the isotope dilution mass spectrometry [IDMS] traceable MDRD Study Equation [SI units])
- Poorly controlled hypertension defined as:
- Systolic BP > 160 mm Hg
- Diastolic BP ≥ 95 mm Hg after 10 minutes of seated rest and confirmed by repeated measurement at screening.
- Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or subjects 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 (New York Heart Association Class III or IV)
- Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
- Haemoglobinopathy, haemolytic anemia, or chronic anaemia (haemoglobin concentration < 11.5 g/dL [115 g/L] for males, < 10.5 g/dL [105 g/L] for females) at screening or any other condition known to interfere with 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 (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
- History of substance dependence, alcohol abuse, or excessive alcohol intake (defined as an average weekly intake of > 21 alcoholic drinks for men or > 10 alcoholic drinks for women) within 3 years prior to screening, and/or a positive screen for drugs of abuse or alcohol at screening or on admission to the study unit. Subjects who use tricyclic antidepressants or benzodiazepines for an established clinical indication may be permitted to enter the study based upon the judgement of the investigator.
- Involvement of any AstraZeneca, MedImmune, contract research organization, or study site employee or their close relatives
- History of acute or chronic pancreatitis or other diseases of the pancreas
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Research Site
Berlin, 10117
Research Site
Magdeburg, 39120
Research Site
Mainz, 55116
Research Site
Neu-Ulm, 89231
Research Site
Neuss, 41460
About this study
Official title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM). Approximately 63 subjects will be enrolled across two cohorts.
Read the detailed description
This is a randomised, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of different doses of MEDI0382 administered as multiple SC doses to subjects with T2DM. Approximately 63 subjects will be enrolled across two cohorts.
For cohort 1, sufficient subjects will be invited to participate in the study such that a maximum of 39 subjects will complete dosing. Subjects in cohort 1 will be randomised using a ratio of 2:1 to one of 2 treatment arms to receive either MEDI0382 or placebo. A maximum of 26 will complete dosing in the active arm and 13 will complete dosing in the placebo arm.
For cohort 2, sufficient subjects will be invited to participate in the study such that a maximum of 24 subjects will complete dosing. Subjects in cohort 2 will be randomised using a ratio of 3:1 to receive either MEDI0382 or placebo. A maximum of 18 will complete dosing in the active arm and 6 will complete dosing in the placebo arm.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MEDI0382, Placebo
- Keywords
- 0382, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382Drug
MEDI0382 will be administered subcutaneously once daily for 49 days.
PlaceboDrug
Placebo will be administered subcutaneously once daily for 49 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Cohort 1 | Placebo comparator | Participants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days. Receives: Drug: Placebo |
| MEDI0382 Cohort 1 | Experimental | Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days Receives: Drug: MEDI0382 |
| PLacebo Cohort 2 | Placebo comparator | Participants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days. Receives: Drug: Placebo |
| MEDI0382 Cohort 2 | Experimental | Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days. Receives: Drug: MEDI0382 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49
The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.
Measured: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
Cohort 1: Percent Change From Baseline in Body Weight to Day 50
The percent change in body weight from baseline to Day 50 is reported.
Measured: Day 1 through Day 50
Secondary outcomes (23)
Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49
The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.
Measured: Baseline (Day -1) through Day 49
Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49
The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.
Measured: Baseline (Day -1) through Day 49
Cohort 1: Change From Baseline in Body Weight to Day 50
The changes in the body weight during the study period from baseline to Day 50 is reported.
Measured: Day 1 through Day 50
Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50
Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.
Measured: Day 1 through Day 50
Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7
The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.
Measured: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).
Measured: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs
Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.
Measured: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
Measured: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
Measured: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema
The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.
Measured: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.
Measured: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.
Measured: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382
The maximum observed concentration of MEDI0382 is reported.
Measured: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382
The maximum observed concentration of MEDI0382 is reported.
Measured: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
The time to reach the maximum observed concentration of MEDI0382 is reported.
Measured: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
The time to reach the maximum observed concentration of MEDI0382 is reported.
Measured: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Terminal Half Life (t1/2) of MEDI0382
The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.
Measured: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Terminal Half Life (t1/2) of MEDI0382
The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.
Measured: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Accumulation Ratio (Racc) of MEDI0382
The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.
Measured: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Accumulation Ratio of MEDI0382
The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.
Measured: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382
Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.
Measured: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382
Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.
Measured: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
Participants with positive serum antibodies to MEDI0382 are reported.
Measured: Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start4 Sep 2017
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244800
- Sponsor's protocol ID
- D5670C00011
- Status last verified
- Nov 2019
- First submitted
- 27 Jul 2017
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosch R, Petrone M, Arends R, Sijbrands EJG, Hoefman S, Snelder N. From In Vitro Efficacy to Long-Term HbA1c Response for GLP-1R/GlucagonR Agonism Using the 4GI-HbA1c Systems Model. CPT Pharmacometrics Syst Pharmacol. 2025 Sep;14(9):1515-1525. doi: 10.1002/psp4.70074. Epub 2025 Jul 16.
PubMed 40665896Parker VER, Robertson D, Wang T, Hornigold DC, Petrone M, Cooper AT, Posch MG, Heise T, Plum-Moerschel L, Schlichthaar H, Klaus B, Ambery PD, Meier JJ, Hirshberg B. Efficacy, Safety, and Mechanistic Insights of Cotadutide, a Dual Receptor Glucagon-Like Peptide-1 and Glucagon Agonist. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz047. doi: 10.1210/clinem/dgz047.
PubMed 31608926
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03244800
- Acronym / sponsor ID
- D5670C00011
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- 0382, T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM). Approximately 63 subjects will be enrolled across two cohorts.
Detailed description
This is a randomised, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of different doses of MEDI0382 administered as multiple SC doses to subjects with T2DM. Approximately 63 subjects will be enrolled across two cohorts.
For cohort 1, sufficient subjects will be invited to participate in the study such that a maximum of 39 subjects will complete dosing. Subjects in cohort 1 will be randomised using a ratio of 2:1 to one of 2 treatment arms to receive either MEDI0382 or placebo. A maximum of 26 will complete dosing in the active arm and 13 will complete dosing in the placebo arm.
For cohort 2, sufficient subjects will be invited to participate in the study such that a maximum of 24 subjects will complete dosing. Subjects in cohort 2 will be randomised using a ratio of 3:1 to receive either MEDI0382 or placebo. A maximum of 18 will complete dosing in the active arm and 6 will complete dosing in the placebo arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Cohort 1 | Placebo comparator | Drug: PlaceboParticipants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days. |
| MEDI0382 Cohort 1 | Experimental | Drug: MEDI0382Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days |
| PLacebo Cohort 2 | Placebo comparator | Drug: PlaceboParticipants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days. |
| MEDI0382 Cohort 2 | Experimental | Drug: MEDI0382Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects aged ≥ 18 years at screening
- Provision of signed and dated written informed consent
- BMI between 27 and 40 kg/m2
- HbA1c range of 6.5% to 8.5%
- Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred in the 3 months prior to screening
Key exclusion criteria (22 listed)
- History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, 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
- Concurrent participation in another study of any kind and repeat randomisation in this study is prohibited
- Severe allergy/hypersensitivity to any of the proposed study treatments
- 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 subject has been treated with daily SC insulin within 90 days prior to screening
- Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
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 |
|---|---|---|
| MEDI0382MEDI0382 will be administered subcutaneously once daily for 49 days. | Drug | MEDI0382 Cohort 1, MEDI0382 Cohort 2 |
| PlaceboPlacebo will be administered subcutaneously once daily for 49 days. | Drug | PLacebo Cohort 2, Placebo Cohort 1 |
Primary outcome
Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49
Time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.
Cohort 1: Percent Change From Baseline in Body Weight to Day 50
Time frame: Day 1 through Day 50
The percent change in body weight from baseline to Day 50 is reported.
23 secondary outcomes
Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49
Time frame: Baseline (Day -1) through Day 49
Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49
Time frame: Baseline (Day -1) through Day 49
Cohort 1: Change From Baseline in Body Weight to Day 50
Time frame: Day 1 through Day 50
Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50
Time frame: Day 1 through Day 50
Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7
Time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs
Time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
Time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema
Time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382
Time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382
Time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Terminal Half Life (t1/2) of MEDI0382
Time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Terminal Half Life (t1/2) of MEDI0382
Time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Accumulation Ratio (Racc) of MEDI0382
Time frame: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Accumulation Ratio of MEDI0382
Time frame: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382
Time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382
Time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
Time frame: Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40665896Bosch R, Petrone M, Arends R, Sijbrands EJG, Hoefman S, Snelder N. From In Vitro Efficacy to Long-Term HbA1c Response for GLP-1R/GlucagonR Agonism Using the 4GI-HbA1c Systems Model. CPT Pharmacometrics Syst Pharmacol. 2025 Sep;14(9):1515-1525. doi: 10.1002/psp4.70074. Epub 2025 Jul 16.
- Derived from this study: PubMed 31608926Parker VER, Robertson D, Wang T, Hornigold DC, Petrone M, Cooper AT, Posch MG, Heise T, Plum-Moerschel L, Schlichthaar H, Klaus B, Ambery PD, Meier JJ, Hirshberg B. Efficacy, Safety, and Mechanistic Insights of Cotadutide, a Dual Receptor Glucagon-Like Peptide-1 and Glucagon Agonist. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz047. doi: 10.1210/clinem/dgz047.
- D5670C00011\_protocol\_amendment\_2\_ctLink provided by the sponsor.
- D5670C00011\_Statistical\_Analysis\_PlanLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
5 sites 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 5 sites 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 22 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 19 Nov 2019). 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?
Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49 (time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal). The study lists 2 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 NCT03244800, which also lists 2 linked publications.
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 19 Nov 2019.