Type 2 DiabetesPhase 1NCT04208620
Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus
A Phase 1 study testing Cotadutide in people with Type 2 Diabetes, run by AstraZeneca at 3 sites in Japan.
Trial summary
This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cotadutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesJapan
- Study dates
- 21 Jan 2020to 8 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses.
- Subject must be 20 to 74 years of age at screening.
- HbA1c range of 6.5% to 8.5% at screening and run-in visit.
- Willing and able to self-inject investigational product for the duration of the study.
- Individuals who are diagnosed with T2DM and have inadequate glycaemic control with diet and exercise.
- Individuals whose current condition at enrolment are drug naïve defined as
Show all 12Show fewer
- Never received medical treatment for diabetes (insulin and/or other anti-diabetic agents [oral or injection]) OR
- Received medical treatment for diabetes for less than 30 days since diagnosis.Subjects also should not have a history of insulin therapy within 2 weeks of screening (with the exception of insulin therapy during a hospitalization for other causes or use in gestational diabetes) OR
- Previously received medical treatment for diabetes but have not been treated within 6 weeks of randomization.
- BMI within the range 25 to 35 kg/m2 at screening.
- Negative pregnancy test for female subjects.
- Female subjects of childbearing potential who are sexually active with a male partner must be willing to use at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of investigational product.
Who cannot join
- Subjects with any of the following results at screening and run-in visit
- 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.
- Acute pancreatitis at screening or 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 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 NASH or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening or run-in visit.
- Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
Show all 37Show fewer
- Alanine transaminase (ALT) ≥ 3 × ULN
- Total bilirubin (TBL) ≥ 2 × ULN
- Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73m2 at screening or run-in visit (GFR estimated according to Modification of Diet in Renal Disease [MDRD] using MDRD Study Equation IDMS-traceable [International System of Units (SI)]).
- Poorly controlled hypertension defined as, For age ≤ 55 years; Systolic BP > 140 mmHg Diastolic BP ≥ 90 mmHg For age > 55 years; Systolic BP > 150 mmHg Diastolic BP ≥ 90 mmHg After 10 minutes of supine rest and confirmed by repeated measurement at screening or run-in visit. Subjects who fail BP screening criteria may be considered for 24-hour or day time ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour BP < 130/80 mmHg with a preserved nocturnal dip of > 15% or day time BP < 135/85 mmHg will be considered eligible
- Resting heart rate is ≥ 80 bpm at screening or run-in visit.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes, including QTc interval changes at screening, as judged by the investigator.
- Prolonged QT intervals corrected for heart rate using Fridericia's formula (QTcF) > 450 msec, or family history of long QT-segment at screening or run-in visit.
- PR (PQ) interval prolongation (> 220 msec), intermittent second (Wenckebach block while asleep is not exclusive), or third-degree atrioventricular (AV) block, or AV dissociation at screening or run-in visit.
- Persistent or intermittent complete bundle branch block. A QRS duration < 120 msec is acceptable if there is no evidence of ventricular hypertrophy or preexcitation at screening or run-in visit.
- Abnormal findings during the exercise stress test, such as chest pain, dyspnoea, presyncope, arrhytmias, signs of cardiac ischemia on ECG as judged by the investigator.
- History of, unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft 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.
- Hemoglobinopathy, hemolytic anemia or chronic anemia (hemoglobin, < 11.5 g/dL [115 g/L]) for males, < 10.5 g/dL (105 g/L) for females) at screening or run-in visit, 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 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 run-in visit. Subjects 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 (eg, anti-depressants, anti-psychotics) at screening. However, subjects who use benzodiazepines for chronic anxiety or sleep disorders may be permitted to enter the study.
- History of severe allergy/hypersensitivity, including to any component of the investigational product formulation including excipients or other biological agent, any of the proposed study treatments, or ongoing clinically important allergy/hypersensitivity.
- Any subject who has received another investigational product as part of a clinical study or a 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.
- Any subject who has received any of the following medications within the specified timeframe prior to the start of the study.
- Herbal preparations within one week prior to the start of screening or drugs licensed for control of body weight or appetite within 30 days (or 5 half-lives of the drug) prior to the start of screening
- Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within 2 weeks prior to the start of dosing
- Antimicrobials within the quinolone, macrolide or azole class within 2 weeks prior to the start of dosing
- Any change in antihypertensive medication within 3 months prior to screening
- Any change in thyroid replacement therapy within 2 months prior to screening
- Aspirin at a total daily dose of greater than 150 mg
- Paracetamol or paracetamol-containing preparations at a total daily dose of greater than 3000 mg
- Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg
- Concurrent participation in another study of any kind and repeat randomization in this study.
- Received Cotadutide in another clinical study prior to enrolment in this study.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Research Site
Shinjuku-ku, 160-0008
Research Site
Shinjuku-ku, 162-0053
Research Site
Suita-shi, 565-0853
About this study
Official title: A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Mellitus
This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.
Read the detailed description
This is a randomized, blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of Cotadutide in Japanese obese subjects with T2DM. Approximately 20 subjects will be screened in total and 16 subjects will be randomized to Cotadutide or placebo in a 3:1 ratio. Those subjects who receive Cotadutide will be titrated up to HCTD. The study has a 2-week screening period, a run-in period of 9 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period (if applicable), followed by a 28-day follow-up period.
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo, Cotadutide
- Keywords
- Diabetes, Cotadutide, MEDI0382, D5671C00003, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo administered subcutaneously
CotadutideDrug
Cotadutide administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered subcutaneously Receives: Drug: Placebo |
| Cotadutide | Experimental | Cotadutide administered subcutaneously Receives: Drug: Cotadutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Incidence of treatment-emergent serious adverse events (TESAEs)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Clinically important changes in 12-lead electrocardiogram (ECG)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Vital signs as measured by pulse rate (bpm)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Vital signs as measured by blood pressure (mmHg)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Physical examination (abnormality to be reported as part of adverse events)
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Clinical laboratory evaluations
To assess the safety and tolerability of Cotadutide
Measured: Baseline until the follow-up period, 28 days post-last dose
Secondary outcomes (16)
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
To characterize the PK profile of Cotadutide
Measured: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Maximum observed concentration (Cmax)
To characterize the PK profile of Cotadutide
Measured: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Time to Cmax (tmax)
To characterize the PK profile of Cotadutide
Measured: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Trough plasma concentration (Ctrough)
To characterize the PK profile of Cotadutide
Measured: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Anti-drug antibodies (ADAs) to Cotadutide
To characterize the immunogenicity of Cotadutide
Measured: At baseline through end of study, 98 days in total
Change in average glucose levels (mg/dL)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: At baseline through end of study, 98 days in total
Change in coefficient of variation
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: At baseline through end of study, 98 days in total
Change in percentage time spent in hyperglycemia (> 140 mg/dL)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: At baseline through end of study, 98 days in total
Change in percentage time spent in normoglycemia (70 -140 mg/dL)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: At baseline through end of study, 98 days in total
Change in percentage time spent in clinically significant hypoglycemia (< 54 mg/dL)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: At baseline through end of study, 98 days in total
Change in estimated hemoglobin A1c (HbA1c)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: At baseline through end of study, 98 days in total
Change in fasting plasma glucose (mg/dL)
To assess the effect of Cotadutide on glucose control as measured by additional measrues of glucose control
Measured: At baseline through end of study, 98 days in total
Change in HbA1c
To assess the effect of Cotadutide on glucose control as measured by additional measrues of glucose control
Measured: At baseline through end of study, 98 days in total
Percentage change in body weight
To assess the effect of Cotadutide on body weight
Measured: At baseline through end of study, 98 days in total
Absolute change in body weight (kg)
To assess the effect of Cotadutide on body weight
Measured: At baseline through end of study, 98 days in total
Proportion of subjects achieving > 5% body weight loss
To assess the effect of Cotadutide on body weight
Measured: At baseline through end of study, 98 days in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start21 Jan 2020
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208620
- Sponsor's protocol ID
- D5671C00003
- Status last verified
- Jul 2020
- First submitted
- 1 Dec 2019
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04208620
- Acronym / sponsor ID
- D5671C00003
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Cotadutide, MEDI0382, D5671C00003, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.
Detailed description
This is a randomized, blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of Cotadutide in Japanese obese subjects with T2DM. Approximately 20 subjects will be screened in total and 16 subjects will be randomized to Cotadutide or placebo in a 3:1 ratio. Those subjects who receive Cotadutide will be titrated up to HCTD. The study has a 2-week screening period, a run-in period of 9 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period (if applicable), followed by a 28-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously |
| Cotadutide | Experimental | Drug: CotadutideCotadutide administered subcutaneously |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses.
- Subject must be 20 to 74 years of age at screening.
- HbA1c range of 6.5% to 8.5% at screening and run-in visit.
- Willing and able to self-inject investigational product for the duration of the study.
- Individuals who are diagnosed with T2DM and have inadequate glycaemic control with diet and exercise.
Key exclusion criteria (37 listed)
- Subjects with any of the following results at screening and run-in visit
- 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.
- Acute pancreatitis at screening or 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 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 NASH or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening or run-in visit.
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 |
|---|---|---|
| PlaceboPlacebo administered subcutaneously | Drug | Placebo |
| CotadutideCotadutide administered subcutaneously | Drug | Cotadutide |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Incidence of treatment-emergent serious adverse events (TESAEs)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Clinically important changes in 12-lead electrocardiogram (ECG)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Vital signs as measured by pulse rate (bpm)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Vital signs as measured by blood pressure (mmHg)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Physical examination (abnormality to be reported as part of adverse events)
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Clinical laboratory evaluations
Time frame: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
16 secondary outcomes
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
Time frame: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Maximum observed concentration (Cmax)
Time frame: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Time to Cmax (tmax)
Time frame: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Trough plasma concentration (Ctrough)
Time frame: Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Anti-drug antibodies (ADAs) to Cotadutide
Time frame: At baseline through end of study, 98 days in total
Change in average glucose levels (mg/dL)
Time frame: At baseline through end of study, 98 days in total
Change in coefficient of variation
Time frame: At baseline through end of study, 98 days in total
Change in percentage time spent in hyperglycemia (> 140 mg/dL)
Time frame: At baseline through end of study, 98 days in total
Change in percentage time spent in normoglycemia (70 -140 mg/dL)
Time frame: At baseline through end of study, 98 days in total
Change in percentage time spent in clinically significant hypoglycemia (< 54 mg/dL)
Time frame: At baseline through end of study, 98 days in total
Change in estimated hemoglobin A1c (HbA1c)
Time frame: At baseline through end of study, 98 days in total
Change in fasting plasma glucose (mg/dL)
Time frame: At baseline through end of study, 98 days in total
Change in HbA1c
Time frame: At baseline through end of study, 98 days in total
Percentage change in body weight
Time frame: At baseline through end of study, 98 days in total
Absolute change in body weight (kg)
Time frame: At baseline through end of study, 98 days in total
Proportion of subjects achieving > 5% body weight loss
Time frame: At baseline through end of study, 98 days in total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cotadutide in people with Type 2 Diabetes, run by AstraZeneca at 3 sites in Japan.
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 12 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline until the follow-up period, 28 days post-last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2020.