Type II Diabetes MellitusPhase 2NCT03550378
A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated
A Phase 2 study testing MEDI0382 in people with Type II Diabetes Mellitus and Renal Insufficiency, run by MedImmune LLC at 7 sites in 2 countries.
Trial summary
A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and kidney problems and also to check that MEDI0382 is well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Type II Diabetes Mellitus, Renal Insufficiency
- 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
- 41 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 29 Jun 2018to 4 Feb 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 85 years at screening.
- Signed and dated written informed consent (with the exception of consent for genetic and nongenetic research) prior to performing any protocol-related procedures, including screening evaluations.
- Diagnosed with type 2 diabetes mellitus (T2DM) with glucose control managed with any insulin and/or oral therapy combination where no significant dose changes of oral therapy of more than 50% have occurred in the 3 months prior to screening
- Body mass index (BMI) between 25 and 45 kg/m^2 (inclusive) at screening
- Haemoglobin A1c (HbA1c) range of 6.5 % to 10.5% (inclusive) at screening
- Renal impairment with estimated glomerular filtration rate (eGFR) ≥ 30 and < 60 mL/min/1.73 m^2 at screening. Approximately 16 participants (40%) are required to have a screening eGFR ≥30 and < 45 mL/min/1.73 m^2 and at least 16 participants (40%) are required to have screening eGFR ≥45 and < 60 mL/min/1.73 m^2.
- Females of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating. Women of childbearing potential who are sexually active with a non-sterilized male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose study drug.
Who cannot join
- History or presence of significant medical or psychological conditions, including substance dependence/abuse, or significant abnormalities in laboratory parameters or vital signs including electrocardiogram (ECG), which in the opinion of the investigator, would compromise the participant's safety or successful participation in the study. As an example, severe anaemia (haemoglobin < 7.0 g/dL) could be exclusionary due to blood sampling required by the protocol, at the discretion of investigator.
- Concurrent participation in another interventional study of any kind and repeat randomisation in this study is prohibited.
- 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 (if known; whichever is longer) at the time of Visit 2.
- Any participant who has received any of the following medications within the specified timeframe prior to the start of the study (Visit 2)
- Herbal preparations within 1 week prior to the start of dosing (Visit 4) or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within 30 days (or 5 half-lives of the drug) prior to the start of dosing (Visit 4)
- Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run-in period (Visit 2)
Show all 29Show fewer
- Paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within 2 weeks prior to the start of dosing (Visit 4)
- Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
- Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis
- Participants who have undergone a renal transplant
- Participants with suspicion of acute or subacute renal function deterioration (eg, participants with large fluctuations of creatinine values documented within the 6 months prior to screening)
- Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal (GI) tract including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
- History of acute or chronic pancreatitis
- Significant hepatic disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results:
- Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
- Alanine transaminase (ALT) ≥ 3 × ULN
- Total bilirubin ≥ 2 × ULN
- Poorly controlled hypertension defined as:
- Systolic blood pressure (BP) > 180 mm Hg
- Diastolic BP ≥ 100 mm Hg Participants who fail BP screening criteria may be considered for 24-hour ambulatory blood pressure monitoring (ABPM) at the discretion of the investigator. Participants who maintain a mean 24-hour systolic BP ≤ 180 or diastolic BP < 100 mm Hg with a preserved nocturnal dip of > 15% will be considered eligible
- 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 (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
- History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell skin cancer, 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
- Nephrotic range proteinuria defined as spot urine albumin creatinine ratio (ACR) > 250 mg/mmol at screening
- 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 Day -5. Participants 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany4 sites
Research Site
Berlin, 10117
Research Site
Magdeburg, 39120
Research Site
München, 81241
Research Site
Münster, 48145
United Kingdom3 sites
Research Site
Dundee, DD1 9SY
Research Site
Edinburgh, EH16 4SA
Research Site
Edinburgh, EH4 2XU
About this study
Official title: A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment
A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and kidney problems and also to check that MEDI0382 is well tolerated.
- Conditions
- Type II Diabetes Mellitus, Renal Insufficiency
- Being tested
- MEDI0382, Placebo
- Keywords
- Type 2 Diabetes Mellitus, MEDI0382, Renal Impairment, Glucose concentration, Hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382Drug
Participants will receive subcutaneous MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
PlaceboDrug
Participants will receive SC placebo matched to MEDI0382 once daily for 32 days.
| Study group | Role | What they receive |
|---|---|---|
| MEDI0382 | Experimental | Participants will receive subcutaneous (SC) dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days. Receives: Drug: MEDI0382 |
| Placebo | Placebo comparator | Participants will receive SC dose of placebo matched to MEDI0382 once daily for 32 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32
The MMTT involved the consumption of a standardised liquid meal (a nutritional supplement containing the components of fat, carbohydrate, and protein, which make up a standard MMTT) within 15 minutes, and timed serial blood samples obtained for measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardized meal (with no additional food intake during this time).
Measured: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32
Secondary outcomes (18)
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. 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: Day 1 through Day 60
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs is reported. Vital sign measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, body temperature, and respiratory rate).
Measured: Day 1 through Day 60
Change From Baseline in Postural Blood Pressure
The change difference is the change from Day 1 to Day 32 in the difference between systolic blood pressure (SBP) or diastolic blood pressure (DBP) values in standing and supine positions. For this outcome measure, participants with difference (standing-supine) in DBP or SBP on Day 1 and Day 32 were analyzed. For few participants either DBP or SBP was recorded eg, standing DBP was not recorded on Day 1 for 2 participants in Placebo arm and 1 participant in MEDI0382 arm; standing SBP was not recorded on Day 32 for a participant in the Placebo arm.
Measured: Baseline (Day 1) through Day 32
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Number of participants with abnormal ECGs reported as TEAEs is reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, ST-T morphology, and QT intervals from the primary lead of the digital 12-lead ECG.
Measured: Day 1 through Day 60
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of participants with abnormal clinical laboratory parameters reported as TEAEs is reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Measured: Day 1 through Day 60
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)
An adverse event of special interest (AESI) was one of scientific and medical interest specific to understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor.
Measured: Day 1 through Day 60
Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level
Change from baseline in mean 24-hrs pulse rate to the end of each dosing levels: Day 5 for 50 μg; Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.
Measured: Day -5 (Baseline) and on Days 5, 12, 19, and 32
Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level
Change from baseline in mean 24-hrs systolic and diastolic blood pressure to the end of each dosing levels: Day 5 for 50 μg, Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.
Measured: Day -5 (Baseline) and on Days 5, 12, 19, and 32
Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32
Change from baseline in haemoglobin A1c (HbA1c) is reported.
Measured: Day 1 (Baseline) and Day 32
Change From Baseline in Fasting Glucose to Day 32
Change from baseline in fasting glucose is reported.
Measured: Day 1 (Baseline) and Day 32
Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment
Change from baseline in percentage of time spent within a target glucose range over a 7-day period to the final week of treatment is reported. Target glucose range was considered as 70 mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L).
Measured: Baseline (Days -8 to -2), Days 5 to 11, Days 12 to 18, Days 19 to 25, and Days 26 to 32 (final week of treatment)
Percent Change Frome Baseline in Body Weight to Day 33
Percent change from baseline in body weight is reported.
Measured: Day 1 (Baseline) and Day 33
Change From Baseline in Absolute Body Weight to Day 33
Change from baseline in absolute body weight is reported.
Measured: Day 1 (Baseline) and Day 33
Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg
Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 at 300 μg is reported.
Measured: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg
Maximum observed serum concentration (Cmax) of MEDI0382 at 300 μg is reported.
Measured: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg
Time to observed maximum serum concentration (Tmax) of MEDI0382 at 300 μg is reported.
Measured: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
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 of MEDI0382 is reported.
Measured: Days 1, 5, 12, and 19: Predose; and Day 32: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose (Day 33)
Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382
Number of participants with positive Anti-drug antibodies (ADA) Titre to MEDI0382 is reported.
Measured: Pre-dose on Days 1, 12, and 32 and on Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start29 Jun 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type II 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
- Model description
- Randomised, Double-Blind, Placebo-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550378
- Sponsor's protocol ID
- D5670C00013
- Other IDs
- 2018-000019-26, 2018
- Status last verified
- Mar 2020
- First submitted
- 27 Apr 2018
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PubMed 39963952Parker VER, Hoang T, Schlichthaar H, Gibb FW, Wenzel B, Posch MG, Rose L, Chang YT, Petrone M, Hansen L, Ambery P, Jermutus L, Heerspink HJL, McCrimmon RJ. Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2022 Jul;24(7):1360-1369. doi: 10.1111/dom.14712. Epub 2022 Apr 25.
PubMed 35403793
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment
- ClinicalTrials.gov ID
- NCT03550378
- Acronym / sponsor ID
- D5670C00013
- Conditions
- Type II Diabetes Mellitus, Renal Insufficiency
- Keywords
- Type 2 Diabetes Mellitus, MEDI0382, Renal Impairment, Glucose concentration, Hemoglobin A1c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and kidney problems and also to check that MEDI0382 is well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| MEDI0382 | Experimental | Drug: MEDI0382Participants will receive subcutaneous (SC) dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive SC dose of placebo matched to MEDI0382 once daily for 32 days. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and < 85 years at screening.
- Signed and dated written informed consent (with the exception of consent for genetic and nongenetic research) prior to performing any protocol-related procedures, including screening evaluations.
- Diagnosed with type 2 diabetes mellitus (T2DM) with glucose control managed with any insulin and/or oral therapy combination where no significant dose changes of oral therapy of more than 50% have occurred in the 3 months prior to screening
- Body mass index (BMI) between 25 and 45 kg/m^2 (inclusive) at screening
- Haemoglobin A1c (HbA1c) range of 6.5 % to 10.5% (inclusive) at screening
Key exclusion criteria (29 listed)
- History or presence of significant medical or psychological conditions, including substance dependence/abuse, or significant abnormalities in laboratory parameters or vital signs including electrocardiogram (ECG), which in the opinion of the investigator, would compromise the participant's safety or successful participation in the study. As an example, severe anaemia (haemoglobin < 7.0 g/dL) could be exclusionary due to blood sampling required by the protocol, at the discretion of investigator.
- Concurrent participation in another interventional study of any kind and repeat randomisation in this study is prohibited.
- 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 (if known; whichever is longer) at the time of Visit 2.
- Any participant who has received any of the following medications within the specified timeframe prior to the start of the study (Visit 2)
- Severe allergy/hypersensitivity to any of the proposed study treatments 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 |
|---|---|---|
| MEDI0382Participants will receive subcutaneous MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days. | Drug | MEDI0382 |
| PlaceboParticipants will receive SC placebo matched to MEDI0382 once daily for 32 days. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32
Time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32
The MMTT involved the consumption of a standardised liquid meal (a nutritional supplement containing the components of fat, carbohydrate, and protein, which make up a standard MMTT) within 15 minutes, and timed serial blood samples obtained for measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardized meal (with no additional food intake during this time).
18 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through Day 60
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Time frame: Day 1 through Day 60
Change From Baseline in Postural Blood Pressure
Time frame: Baseline (Day 1) through Day 32
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Time frame: Day 1 through Day 60
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Time frame: Day 1 through Day 60
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Time frame: Day 1 through Day 60
Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level
Time frame: Day -5 (Baseline) and on Days 5, 12, 19, and 32
Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level
Time frame: Day -5 (Baseline) and on Days 5, 12, 19, and 32
Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32
Time frame: Day 1 (Baseline) and Day 32
Change From Baseline in Fasting Glucose to Day 32
Time frame: Day 1 (Baseline) and Day 32
Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment
Time frame: Baseline (Days -8 to -2), Days 5 to 11, Days 12 to 18, Days 19 to 25, and Days 26 to 32 (final week of treatment)
Percent Change Frome Baseline in Body Weight to Day 33
Time frame: Day 1 (Baseline) and Day 33
Change From Baseline in Absolute Body Weight to Day 33
Time frame: Day 1 (Baseline) and Day 33
Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Trough Plasma Concentration (Ctrough) of MEDI0382
Time frame: Days 1, 5, 12, and 19: Predose; and Day 32: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose (Day 33)
Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382
Time frame: Pre-dose on Days 1, 12, and 32 and on Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39963952Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
- Derived from this study: PubMed 35403793Parker VER, Hoang T, Schlichthaar H, Gibb FW, Wenzel B, Posch MG, Rose L, Chang YT, Petrone M, Hansen L, Ambery P, Jermutus L, Heerspink HJL, McCrimmon RJ. Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2022 Jul;24(7):1360-1369. doi: 10.1111/dom.14712. Epub 2022 Apr 25.
- D5670C00013 CSP redactedLink provided by the sponsor.
- D5670C00013 - SAP\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: 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 II Diabetes Mellitus and Renal Insufficiency, run by MedImmune LLC at 7 sites in 2 countries.
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 7 inclusion and 29 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United Kingdom. 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 13 Apr 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?
Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32 (time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32). 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 NCT03550378, 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 13 Apr 2020.