A Phase 1 interventional study of MEDI0382 Formulation 2 and MEDI0382 Formulation 3 in Type 2 Diabetes Mellitus, sponsored by MedImmune LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 1, Interventional, and Other
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Among 15 studies testing cotadutide in Diabetes Mellitus, Type 2 — none open to participants now, none under way, none of them phase 3. cotadutide · Diabetes Mellitus, Type 2.
Among the 15 studies testing cotadutide in Diabetes Mellitus, Type 2, this one is the 10th largest by enrollment, is one of 4 that started in 2017, is one of 5 in phase 1, and was the 4th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →None of the 15 studies testing cotadutide in Diabetes Mellitus, Type 2 is open now. The open studies under Diabetes Mellitus, Type 2, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10
First in 2015; this study’s year is marked. 4 started in 2017.
This study's enrollment of 24 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 41 across the 15 interventional studies. Of the 15 that completed or were terminated, 10 (67%) have results posted.
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15 of 15 have an industry lead sponsor. The 2 most frequent:
This study is registered under MedImmune LLC, one of the names counted as AstraZeneca. Under that name alone:
MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
345 studies in Diabetes Mellitus, Type 2 by AstraZeneca: 13 open now, 15 under way, 9 of them phase 3. Of 325 finished, 149 (46%) have results posted.
Among the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca, this one is the 239th largest by enrollment of the 280 interventional ones that give a count, is one of 22 that started in 2017, is one of 86 in phase 1, and was the 288th registered.
AstraZeneca’s Diabetes Mellitus, Type 2 studies by the year they started, since 2001.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing cotadutide in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 345 in Diabetes Mellitus, Type 2:
This tab as a report to print or save as PDF → With an account.
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously.
Subjects will receive the same absolute amount of MEDI0382, when dosed with either formulation 2 or formulation 3. Formulations of MEDI0382 will be administered via SC injection in the abdomen of subjects. Subjects will be in the study for a maximum of 59 days, which includes a screening period of up to 21 days. On Day 1, subjects will admitted to the clinic and will be randomized to receive formulation 2 and formulation 3 in one of two sequences; subjects randomized to sequence 1 will receive formulation 2 on Day 1 and formulation 3 on Day 10 and subjects randomized to sequence 2 will receive formulation 3 on Day 1 and formulation 2 on Day 10.
On Day 3, subjects will be discharged from the clinic and a 7-day washout period will follow. Subjects will return to the clinic on Day 10 to receive the second dose of investigational product and will remain in-house for 3 days. After discharge on Day 12, subjects will return on Day 38 for the end of study visit. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
formulation 2 on Day 1 and formulation 3 on Day 10
Drug: MEDI0382 Formulation 2 · Drug: MEDI0382 Formulation 3
formulation 3 on Day 1 and formulation 2 on Day 10
Drug: MEDI0382 Formulation 2 · Drug: MEDI0382 Formulation 3
Sequence 1 Period 1 and Sequence 2 Period 2.
Sequence 1 Period 2 and Sequence 2 Period 1
Area under the drug concentration curve
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
Time frame: 48 hours
Maximum observed plasma concentration of MEDI0382
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.
Time frame: 48 hours
Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Time to maximum observed plasma drug concentration
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Terminal phase elimination half-life
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Apparent clearance
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Adverse Events
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Anti-drug antibody titer
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Vital signs (temperature)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Anti-drug antibody incidence
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Clinical laboratory assessments (hematology)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Vital signs (systolic and diastolic blood pressure)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Vital signs (pulse rate and respiratory rate)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Clinical laboratory assessments (serum chemistry)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Clinical laboratory assessments (urinalysis)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Ran from Nov 2017 to primary completion in Jan 2018, 1 month.
Of 453 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 1 month is below that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cotadutide