Type 2 DiabetesPhase 2NCT03645421

Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes

A Phase 2 study testing MEDI0382 100 μg, MEDI0382 200 μg and MEDI0382 300 μg in people with Type 2 Diabetes, run by AstraZeneca at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects. The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. Read more about this study

Who is it for?: Ages 20 to 120 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: MEDI0382 100 μg, MEDI0382 200 μg and MEDI0382 300 μg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 5 sitesJapan
Study dates: 10 Aug 2018to 17 Jan 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 20 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.
Individuals who are diagnosed with T2DM
Individuals whose current condition at enrolment (Visit 1) is drug naïve
BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

Who cannot join

Subjects with any of the following results at screening:
Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)
Alanine transaminase (ALT) ≥ 2.5 × ULN
Total bilirubin (TBL) ≥ 2 × ULN
Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 at screening
Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Shinjuku-ku, 160-0008
Research Site
Shinjuku-ku, 162-0053
Research Site
Suita-shi, 565-0853

Other trials in Japan

About this study

Official title: A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.

The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.

Read the detailed description

This is a randomized, parallel-group, placebo-controlled, double-blind, multicenter Phase Ⅱa study to evaluate the safety, efficacy, and pharmacokinetics of MEDI0382 in Japanese preobese and obese subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. Subject fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1:1 ratio to four treatment arms. This is a Phase IIa study designed to evaluate the dose range for MEDI0382 to explore the safety profile, as well as blood glucose control and weight loss effects of MEDI0382 in Japanese patients with T2DM. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382, such that benefit-risk balance for the Japanese preobese and obese patients with T2DM in this study is considered favourable. A treatment period of 48 days is required to properly evaluate the dose range and safety and tolerability in three different doses. Inclusion of placebo in the study allows appropriate basis of AEs, glycaemic control, and weight loss. Benefits related to participation in this trial include close follow-up of a subject's diabetes and treatment with anti-diabetes agents. Although one of possible treatments is placebo, appropriate rescue therapy for worsening glycaemic control will be implemented if required.

Conditions: Type 2 Diabetes
Being tested: MEDI0382 100 μg, MEDI0382 200 μg, MEDI0382 300 μg, PlaceboA, MEDI0382 50 ug
Keywords: Diabetes, MEDI0382, D5674C00001, T2DM, 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.

MEDI0382 100 μgDrug
Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose
MEDI0382 200 μgDrug
Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose
MEDI0382 300 μgDrug
Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose
PlaceboADrug
1.0 mL liquid formulation per Vial
MEDI0382 50 ugDrug
Solution for injection, 1.0 mL per vial, 50 ug
PlaceboBDrug
Solution for injection in 1.0 mL pre-filled syringe.

Study groups in NCT03645421
Study group	Role	What they receive
placebo	Placebo comparator	Placebo per day,SC injection on 48 days. Receives: Drug: PlaceboA; Drug: PlaceboB
MEDI0382 100μg	Experimental	50 μg/day,SC injection on the first 5 days and 100 μg/day,SC injection on 43 days Receives: Drug: MEDI0382 100 μg; Drug: MEDI0382 50 ug
MEDI0382 200μg	Experimental	50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days and 200 μg/day,SC injection on 36 days. Receives: Drug: MEDI0382 100 μg; Drug: MEDI0382 200 μg; Drug: MEDI0382 50 ug
MEDI0382 300μg	Experimental	50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days, 200 μg/day,SC injection on 7 days and 300 μg/day,SC injection on 29 days Receives: Drug: MEDI0382 100 μg; Drug: MEDI0382 200 μg; Drug: MEDI0382 300 μg; Drug: MEDI0382 50 ug

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48
Twenty four-hour heart rate was determined using an ambulatory blood pressure monitoring (ABPM) device, and the mean change from baseline in the 24-hour heart rate is presented for Days 20 and 48.
Measured: Baseline (Day -1) and Days 20 and 48.
Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48
Twenty four-hour BP was determined using an ABPM device, and the mean change from baseline in the 24-hour systolic BP and 24-hour diastolic BP are presented for Days 20 and 48.
Measured: Baseline (Day -1) and Days 20 and 48.
Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48
The MMT was conducted following a minimum 8-hour fast. Blood samples for glucose monitoring were taken 15 minutes before the patient consumed a standardised meal, and samples were taken at intervals after the meal, up to 4 hours. The MMT glucose AUC(0-4h) was calculated using a trapezoidal method, and the mean percentage change from baseline at Day 48 was analysed using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline as a covariate.
Measured: Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.
Mean Percentage Change From Baseline in Body Weight at Day 48
The mean percentage change from baseline in body weight at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (last observation carried forward [LOCF]).
Measured: Baseline (Day -1) and Day 48.
Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.
Digital ECGs were taken at baseline and predose and postdose on Days 1, 6, 13, 20 and 48. The mean change from baseline is presented.
Measured: Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.
Number of Patients Who Experienced Adverse Events (AEs)
AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP. Serious AEs (SAEs) were collected from signing of informed consent. The numbers of patients who experienced any AE, any SAE (including events with an outcome of death), and any AE leading to discontinuation of IP are presented.
Measured: Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).

Secondary outcomes (9)

Mean Change From Baseline in HbA1c at Day 48
The mean change from baseline in HbA1c at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).
Measured: Baseline (Day -1) and Day 48 (predose).
Mean Change From Baseline in Fasting Plasma Glucose at Day 48
The mean change from baseline in fasting plasma glucose at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).
Measured: Baseline (Day -1) and Day 48 (predose).
Mean Change From Baseline in Fructosamine at Day 48
The mean change from baseline in fructosamine at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (LOCF).
Measured: Baseline (Day -1) and Day 48 (predose).
Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47
Hyperglycaemia was defined as blood glucose >7.8 mmol/L or >140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the indicated timepoints is presented.
Measured: Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.
Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47
Hypoglycaemia was defined as blood glucose <3 mmol/L or <54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the timepoints is presented.
Measured: Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.
Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels
Hyperglycaemia was defined as blood glucose >7.8 mmol/L or >140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the dose levels (during titration) is presented, up to Day 47, per randomised group.
Measured: Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.
Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels
Hyp0glycaemia was defined as blood glucose <3 mmol/L or <54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the randomised dose levels (during titration) is presented, up to Day 47, per randomised group.
Measured: Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.
Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48
To evaluate pharmacokinetics (PK), blood samples were collected predose and Ctrough of MEDI0382 was determined. Results are presented for Days 2, 5, 34 and 48.
Measured: Blood samples collected predose on Days 1 to 6, 13, 20, 34 and 48.
Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382
The number of patients who were ADA positive at baseline and/or post-baseline are presented. Persistent positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
+ve = positive
Measured: Samples were collected predose on days 1, 13, 20 and 48, and 7 to 14 days after administration of last dose of IP.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 201817 Jan 2019

First posted24 Aug 2018
Study start10 Aug 2018
Primary completion17 Jan 2019
Study completion17 Jan 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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645421
Sponsor's protocol ID: D5674C00001
Status last verified: Dec 2019
First submitted: 25 Jun 2018
Last updated: 23 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
ClinicalTrials.gov ID: NCT03645421
Acronym / sponsor ID: D5674C00001
Conditions: Type 2 Diabetes
Keywords: Diabetes, MEDI0382, D5674C00001, T2DM, Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Aug 2018 (actual)
Primary completion: 17 Jan 2019 (actual)
Study completion: 17 Jan 2019 (actual)
First posted: 24 Aug 2018 (actual)
Results: Posted 23 Dec 2019

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 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
placebo	Placebo comparator	Drug: PlaceboA, Drug: PlaceboBPlacebo per day,SC injection on 48 days.
MEDI0382 100μg	Experimental	Drug: MEDI0382 100 μg, Drug: MEDI0382 50 ug50 μg/day,SC injection on the first 5 days and 100 μg/day,SC injection on 43 days
MEDI0382 200μg	Experimental	Drug: MEDI0382 100 μg, Drug: MEDI0382 200 μg, Drug: MEDI0382 50 ug50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days and 200 μg/day,SC injection on 36 days.
MEDI0382 300μg	Experimental	Drug: MEDI0382 100 μg, Drug: MEDI0382 200 μg, Drug: MEDI0382 300 μg, Drug: MEDI0382 50 ug50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days, 200 μg/day,SC injection on 7 days and 300 μg/day,SC injection on 29 days

Who may qualify

Ages: 20 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.
Individuals who are diagnosed with T2DM
Individuals whose current condition at enrolment (Visit 1) is drug naïve
BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

Key exclusion criteria (6 listed)

Subjects with any of the following results at screening:
Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)
Alanine transaminase (ALT) ≥ 2.5 × ULN
Total bilirubin (TBL) ≥ 2 × ULN
Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 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
MEDI0382 100 μgSolution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose	Drug	MEDI0382 100μg, MEDI0382 200μg, MEDI0382 300μg
MEDI0382 200 μgSolution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose	Drug	MEDI0382 200μg, MEDI0382 300μg
MEDI0382 300 μgSolution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose	Drug	MEDI0382 300μg
PlaceboA1.0 mL liquid formulation per Vial	Drug	placebo
MEDI0382 50 ugSolution for injection, 1.0 mL per vial, 50 ug	Drug	MEDI0382 100μg, MEDI0382 200μg, MEDI0382 300μg
PlaceboBSolution for injection in 1.0 mL pre-filled syringe.	Drug	placebo

Primary outcome

Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48
Time frame: Baseline (Day -1) and Days 20 and 48.
Twenty four-hour heart rate was determined using an ambulatory blood pressure monitoring (ABPM) device, and the mean change from baseline in the 24-hour heart rate is presented for Days 20 and 48.
Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48
Time frame: Baseline (Day -1) and Days 20 and 48.
Twenty four-hour BP was determined using an ABPM device, and the mean change from baseline in the 24-hour systolic BP and 24-hour diastolic BP are presented for Days 20 and 48.
Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48
Time frame: Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.
The MMT was conducted following a minimum 8-hour fast. Blood samples for glucose monitoring were taken 15 minutes before the patient consumed a standardised meal, and samples were taken at intervals after the meal, up to 4 hours. The MMT glucose AUC(0-4h) was calculated using a trapezoidal method, and the mean percentage change from baseline at Day 48 was analysed using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline as a covariate.
Mean Percentage Change From Baseline in Body Weight at Day 48
Time frame: Baseline (Day -1) and Day 48.
The mean percentage change from baseline in body weight at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (last observation carried forward [LOCF]).
Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.
Time frame: Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.
Digital ECGs were taken at baseline and predose and postdose on Days 1, 6, 13, 20 and 48. The mean change from baseline is presented.
Number of Patients Who Experienced Adverse Events (AEs)
Time frame: Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).
AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP. Serious AEs (SAEs) were collected from signing of informed consent. The numbers of patients who experienced any AE, any SAE (including events with an outcome of death), and any AE leading to discontinuation of IP are presented.

9 secondary outcomes

Mean Change From Baseline in HbA1c at Day 48
Time frame: Baseline (Day -1) and Day 48 (predose).
Mean Change From Baseline in Fasting Plasma Glucose at Day 48
Time frame: Baseline (Day -1) and Day 48 (predose).
Mean Change From Baseline in Fructosamine at Day 48
Time frame: Baseline (Day -1) and Day 48 (predose).
Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47
Time frame: Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.
Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47
Time frame: Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.
Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels
Time frame: Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.
Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels
Time frame: Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.
Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48
Time frame: Blood samples collected predose on Days 1 to 6, 13, 20, 34 and 48.
Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382
Time frame: Samples were collected predose on days 1, 13, 20 and 48, and 7 to 14 days after administration of last dose of IP.

Results and safety

Results posted to the registry on 23 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	16	16
MEDI0382 100 mcg	15	15
MEDI0382 200 mcg	15	10
MEDI0382 300 mcg	15	11

Primary outcome: Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48

Time frame: Baseline (Day -1) and Days 20 and 48.. Mean (Standard Deviation). Unit: beats/minute

Measure	Placebo n = 16	MEDI0382 100 mcg n = 15	MEDI0382 200 mcg n = 15	MEDI0382 300 mcg n = 15
Day 20	-1.86 (7.43)	6.65 (7.46)	13.50 (5.86)	15.80 (7.86)
Day 48	-0.25 (7.24)	7.87 (8.60)	12.81 (4.93)	15.22 (5.50)

Population analysed: The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.

Primary outcome: Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48

Time frame: Baseline (Day -1) and Days 20 and 48.. Mean (Standard Deviation). Unit: millimetres of mercury

Measure	Placebo n = 16	MEDI0382 100 mcg n = 15	MEDI0382 200 mcg n = 15	MEDI0382 300 mcg n = 15
24-hour Systolic BP: Day 20	2.98 (9.00)	-4.09 (8.93)	-7.24 (10.54)	-2.48 (9.28)
24-hour Systolic BP: Day 48	0.08 (14.32)	-2.27 (12.42)	-5.17 (19.35)	-6.97 (7.48)
24-hour Diastolic BP: Day 20	0.98 (4.34)	-0.62 (3.42)	-1.41 (4.56)	0.81 (5.58)
24-hour Diastolic BP: Day 48	-0.06 (6.82)	-0.66 (4.56)	-0.27 (9.17)	-0.68 (3.88)

Primary outcome: Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48

Time frame: Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.. Least squares mean (95% Confidence Interval). Unit: Percentage change

Measure	Placebo n = 16	MEDI0382 100 mcg n = 15	MEDI0382 200 mcg n = 15	MEDI0382 300 mcg n = 15
Value	2.45 (-3.37 to 8.26)	-39.66 (-45.67 to -33.66)	-31.16 (-38.61 to -23.71)	-37.86 (-44.95 to -30.76)

Placebo vs MEDI0382 100 mcg: Least squares (LS) mean difference: -42.11 (95% CI -50.47 to -33.75), p <0.0001, ANCOVA
Placebo vs MEDI0382 200 mcg: LS mean difference: -33.61 (95% CI -43.04 to -24.18), p <0.0001, ANCOVA
Placebo vs MEDI0382 300 mcg: LS mean difference: -40.30 (95% CI -49.49 to -31.12), p <0.0001, ANCOVA

Population analysed: The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. MMTs were not conducted on patients who prematurely discontinued IP.

Primary outcome: Mean Percentage Change From Baseline in Body Weight at Day 48

Time frame: Baseline (Day -1) and Day 48.. Least squares mean (95% Confidence Interval). Unit: Percentage change

Measure	Placebo n = 16	MEDI0382 100 mcg n = 15	MEDI0382 200 mcg n = 15	MEDI0382 300 mcg n = 15
Value	-0.82 (-2.06 to 0.43)	-2.12 (-3.40 to -0.84)	-3.34 (-4.68 to -2.01)	-3.34 (-4.61 to -2.06)

Placebo vs MEDI0382 100 mcg: LS mean difference: -1.30 (95% CI -3.08 to 0.47), p = 0.1476, ANCOVA
Placebo vs MEDI0382 200 mcg: LS mean difference: -2.53 (95% CI -4.37 to -0.69), p = 0.0080, ANCOVA
Placebo vs MEDI0382 300 mcg: LS mean difference: -2.52 (95% CI -4.30 to -0.74), p = 0.0063, ANCOVA

Population analysed: The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP (approximately 9 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16
MEDI0382 100 mcg	0 of 15 (0%)	6 of 15 (40%)	0 of 15
MEDI0382 200 mcg	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15
MEDI0382 300 mcg	0 of 15 (0%)	9 of 15 (60%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
d5674c00001 CSP redactedLink provided by the sponsor.
Statistical Analysis Plan (SAP) redactedLink provided by the sponsor.

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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.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI0382 100 μg, MEDI0382 200 μg and MEDI0382 300 μg in people with Type 2 Diabetes, run by AstraZeneca at 5 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 4 inclusion and 6 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in 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 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 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48 (time frame: Baseline (Day -1) and Days 20 and 48.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645421.

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 23 Dec 2019.