DiabetesPhase 1COTA China PKNCT05437848
Chinese Multiple Dose Escalation (MDE) High Dose Study
A Phase 1 study testing Experimental: Cotadutide in people with Diabetes, run by AstraZeneca at 2 sites in China.
Trial summary
A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Overweight/Obese Subjects with Chinese ancestry with Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Experimental: 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
- 2 sitesChina
- Study dates
- 25 Feb 2022to 12 Dec 2022
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 to 74 years
- Provision of signed and dated written informed consent prior to any study specific procedures
- BMI between 25 and 35 kg/m2
- HbA1c range of 7% to 8.5%
- Willing and able to self-inject investigational product
- Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change has occurred in the three months prior to screening.
- Women of child-bearing potential who are sexually active with a male partner must be using at least one highly effective method of contraception. And must have a negative serum or urine pregnancy test within 72 hours prior to the start of IP, and must not be breastfeeding.
Who cannot join
- Any subject who has received another IP 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
- Concurrent participation in another randomization study of any kind; repeat randomization is prohibited
- Any subject who has received any of the following medications within the specified timeframe prior to the start of the study
- Herbal preparations for control of body weight or appetite
- Drugs licensed for control of body weight or appetite
- Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying
Show all 36Show fewer
- Antimicrobials within the quinolone (eg, ciprofloxacin), macrolide (eg, clarithromycin) or azole class (eg, ketoconazole)
- Any change in antihypertensive medication
- Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily
- Paracetamol (acetaminophen) 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
- Symptoms of acutely decompensated blood glucose control, recent severe hypoglycemia, a history of T1DM orDKA
- Acute pancreatitis at screening or history of acute pancreatitis or chronic pancreatitis or serum triglyceride levels > 11 mmol/L at screening
- Significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper GI tract, which may affect gastric emptying or could affect the interpretation of safety and tolerability data
- Significant hepatic disease (except for NASH or NAFLD without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
- AST ≥ 3 × ULN
- ALT ≥ 3 × ULN
- TBL ≥ 2 × ULN
- Impaired renal function defined as eGFR< 30 mL/minute/1.73m2 at screening
- Poorly controlled hypertension defined as:
- SBP > 160 mmHg
- DBP or ≥ 90 mmHg - After 10 minutes of supine rest and confirmed by repeated measurement at screening. Subjects who fail BP screening criteria may be considered for 24-hour ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour BP < 160/100 mmHg with a preserved nocturnal dip of > 15% will be considered eligible.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes, including QTc interval changes at screening, as judged by the investigator, and prolonged QTcF > 450 ms, or family history of long QT-segment at screening
- PR (PQ) interval prolongation, intermittent second (Wenckebach block while asleep is not exclusive), or third-degree AV block, or AV dissociation
- Persistent or intermittent complete bundle branch block.
- Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to screening, or 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 (NYHA Class III or IV)
- Basal calcitonin level ≥ 50 ng/L at screening or history/family history of medullary thyroid carcinoma or MEN2
- 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 HIV antibody
- History of substance dependence, alcohol abuse, or excessive alcohol intake 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.
- 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 or other biological agent, or ongoing clinically important allergy/hypersensitivity as judged by the investigator
- Blood/plasma donation within 1 month of screening
- Involvement of any AstraZeneca, the contract research organization, or the virtual study site employee or their close relatives
- For women only- currently pregnant (confirmed with positive pregnancy test) or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Chinese Overweight/Obese Subjects With Type 2 Diabetes Mellitus
A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Overweight/Obese Subjects with Chinese ancestry with Type 2 Diabetes Mellitus
Read the detailed description
This is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of cotadutide in overweight or obese subjects with T2DM. This study will enroll subjects aged 18 to 74 years with a body mass index (BMI) ≥ 25 and ≤ 35 kg/m2. Subjects will have a diagnosis of T2DM and inadequate blood glucose control as defined by a HbA1c of 7% to 8.5%, and will be on metformin monotherapy in the three months prior to screening. Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide [n=12] and placebo [n=4]) at multicentre in China mainland. Those subjects who receive cotadutide once daily SC will be titrated to a maximum of 600 μg once daily SC, beginning at 50 μg once daily SC. The study has about 2 weeks screening period, a run-in period of 10 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period at the dose of 600 μg and followed by a 28-day follow-up period.
- Conditions
- Diabetes
- Being tested
- Experimental: Cotadutide, Placebo
- Keywords
- Diabetes, Cotadutide, MEDI0382, D5671C00005, Type 2 Diabetes mellitus, Obesity, Overweight
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: CotadutideDrug
Cotadutide: subcutaneous (SC) injection
PlaceboOther
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cotadutide | Experimental | Those subjects who were randomized to cotadutide once daily SC will begin at 50 μg once daily, then up-titrated to 100 μg once daily a week later, after that up-titration will be done at 100 μg increment weekly, till to a maximum of 600 μg once daily. Receives: Drug: Experimental: Cotadutide |
| Placebo | Placebo comparator | Placebo: Placebo subcutaneous injection Receives: Other: Placebo |
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), 98 days in total
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), 98 days in total
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals as measured by digitial 12-lead ECG.
Measured: Baseline until the follow-up period (28 days post last dose), 98 days in total
Number of participants with abnormal vital signs reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital sign parameters (Systolic Blood Pressure, Diastolic Blood Pressure, Pulse, Respiration rate, body temperature).
Measured: Baseline until the follow-up period (28 days post last dose), 98 days in total
Number of Participants With Abnormal Physical Examinations Reported as TEAEs
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and enocrine.
Measured: Baseline until the follow-up period (28 days post last dose), 98 days in total
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
To characterize the PK profile of Cotadutide
Measured: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Maximum observed concentration (Cmax)
To characterize the PK profile of Cotadutide
Measured: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Time to Cmax (tmax)
To characterize the PK profile of Cotadutide
Measured: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Trough plasma concentration (Ctrough)
To characterize the PK profile of Cotadutide
Measured: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urinalysis.
Measured: Baseline until the follow-up period (28 days post last dose), 98 days in total
Secondary outcomes (13)
Anti-drug antibodies (ADAs) to Cotadutide
To characterize the immunogenicity of Cotadutide
Measured: Day 1 of Up-titration treatment period through end of study, 98 days in total
Change in daily average glucose levels
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: baseline to the end of extension period, and during 14 days of the follow up period, 84 days in total.
Change in 7-day average glucose levels
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in hyperglycemia (> 140 mg/dL) over 24hours and over 7days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in target range (70 -140 mg/dL) over 24hours and over 7days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in the range (< 54 mg/dL) over 24hours and over 7days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in estimated hemoglobin A1c (HbA1c)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: Baseline through 21day treatment extension period, 70 days in total
Change in fasting plasma glucose (mg/dL)
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on additional measures of glucose control
Measured: Baseline through 21day treatment extension period, 70 days in total
Change in HbA1c
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on additional measures of glucose control
Measured: Baseline through 21day treatment extension period, 70 days in total
Percentage change in body weight
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight
Measured: Baseline through 21day treatment extension period, 70 days in total
Absolute change in body weight
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight
Measured: Baseline through 21day treatment extension period, 70 days in total
Proportion of subjects achieving > 5% body weight loss
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight
Measured: Baseline through 21day treatment extension period, 70 days in total
Change in coefficient of variation as measured by CGM over 7 days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Measured: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start25 Feb 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide \[n=12\] and placebo \[n=4\]) at multicenter in China mainland.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437848
- Sponsor's protocol ID
- D5671C00005
- Acronym
- COTA China PK
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2022
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Chinese Overweight/Obese Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05437848
- Acronym / sponsor ID
- COTA China PK / D5671C00005
- Conditions
- Diabetes
- Keywords
- Diabetes, Cotadutide, MEDI0382, D5671C00005, Type 2 Diabetes mellitus, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 29 Jun 2022 (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.
A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Overweight/Obese Subjects with Chinese ancestry with Type 2 Diabetes Mellitus
Detailed description
This is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of cotadutide in overweight or obese subjects with T2DM. This study will enroll subjects aged 18 to 74 years with a body mass index (BMI) ≥ 25 and ≤ 35 kg/m2. Subjects will have a diagnosis of T2DM and inadequate blood glucose control as defined by a HbA1c of 7% to 8.5%, and will be on metformin monotherapy in the three months prior to screening. Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide [n=12] and placebo [n=4]) at multicentre in China mainland. Those subjects who receive cotadutide once daily SC will be titrated to a maximum of 600 μg once daily SC, beginning at 50 μg once daily SC. The study has about 2 weeks screening period, a run-in period of 10 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period at the dose of 600 μg and followed by a 28-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide [n=12] and placebo [n=4]) at multicenter in China mainland.
| Arm | Type | Receives |
|---|---|---|
| Cotadutide | Experimental | Drug: Experimental: CotadutideThose subjects who were randomized to cotadutide once daily SC will begin at 50 μg once daily, then up-titrated to 100 μg once daily a week later, after that up-titration will be done at 100 μg increment weekly, till to a maximum of 600 μg once daily. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo: Placebo subcutaneous injection |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged 18 to 74 years
- Provision of signed and dated written informed consent prior to any study specific procedures
- BMI between 25 and 35 kg/m2
- HbA1c range of 7% to 8.5%
- Willing and able to self-inject investigational product
Key exclusion criteria (36 listed)
- Any subject who has received another IP 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
- Concurrent participation in another randomization study of any kind; repeat randomization is prohibited
- Any subject who has received any of the following medications within the specified timeframe prior to the start of the study
- Symptoms of acutely decompensated blood glucose control, recent severe hypoglycemia, a history of T1DM orDKA
- Acute pancreatitis at screening or history of acute pancreatitis or chronic pancreatitis or serum triglyceride levels > 11 mmol/L at screening
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 |
|---|---|---|
| Experimental: CotadutideCotadutide: subcutaneous (SC) injection | Drug | Cotadutide |
| PlaceboPlacebo subcutaneous injection | Other | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
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), 98 days in total
To assess the safety and tolerability of Cotadutide
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals as measured by digitial 12-lead ECG.
Number of participants with abnormal vital signs reported as TEAEs
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital sign parameters (Systolic Blood Pressure, Diastolic Blood Pressure, Pulse, Respiration rate, body temperature).
Number of Participants With Abnormal Physical Examinations Reported as TEAEs
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and enocrine.
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
To characterize the PK profile of Cotadutide
Maximum observed concentration (Cmax)
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
To characterize the PK profile of Cotadutide
Time to Cmax (tmax)
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
To characterize the PK profile of Cotadutide
Trough plasma concentration (Ctrough)
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
To characterize the PK profile of Cotadutide
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urinalysis.
13 secondary outcomes
Anti-drug antibodies (ADAs) to Cotadutide
Time frame: Day 1 of Up-titration treatment period through end of study, 98 days in total
Change in daily average glucose levels
Time frame: baseline to the end of extension period, and during 14 days of the follow up period, 84 days in total.
Change in 7-day average glucose levels
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in hyperglycemia (> 140 mg/dL) over 24hours and over 7days
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in target range (70 -140 mg/dL) over 24hours and over 7days
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in the range (< 54 mg/dL) over 24hours and over 7days
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in estimated hemoglobin A1c (HbA1c)
Time frame: Baseline through 21day treatment extension period, 70 days in total
Change in fasting plasma glucose (mg/dL)
Time frame: Baseline through 21day treatment extension period, 70 days in total
Change in HbA1c
Time frame: Baseline through 21day treatment extension period, 70 days in total
Percentage change in body weight
Time frame: Baseline through 21day treatment extension period, 70 days in total
Absolute change in body weight
Time frame: Baseline through 21day treatment extension period, 70 days in total
Proportion of subjects achieving > 5% body weight loss
Time frame: Baseline through 21day treatment extension period, 70 days in total
Change in coefficient of variation as measured by CGM over 7 days
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
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 7 Nov 2023.
- 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 Diabetes
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
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.
2 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 Experimental: Cotadutide in people with Diabetes, run by AstraZeneca at 2 sites in China.
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 36 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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), 98 days in total). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.