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

NCT ID: NCT03645421

Last Updated: 2019-12-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2019-01-17

Brief Summary

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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.

Detailed Description

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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

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Type 2 Diabetes

Keywords

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Diabetes MEDI0382 D5674C00001 T2DM Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Placebo per day,SC injection on 48 days.

Group Type PLACEBO_COMPARATOR

PlaceboA

Intervention Type DRUG

1.0 mL liquid formulation per Vial

PlaceboB

Intervention Type DRUG

Solution for injection in 1.0 mL pre-filled syringe.

MEDI0382 100μg

50 μg/day,SC injection on the first 5 days and 100 μg/day,SC injection on 43 days

Group Type EXPERIMENTAL

MEDI0382 100 μg

Intervention Type DRUG

Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose

MEDI0382 50 ug

Intervention Type DRUG

Solution for injection, 1.0 mL per vial, 50 ug

MEDI0382 200μg

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.

Group Type EXPERIMENTAL

MEDI0382 100 μg

Intervention Type DRUG

Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose

MEDI0382 200 μg

Intervention Type DRUG

Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose

MEDI0382 50 ug

Intervention Type DRUG

Solution for injection, 1.0 mL per vial, 50 ug

MEDI0382 300μg

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

Group Type EXPERIMENTAL

MEDI0382 100 μg

Intervention Type DRUG

Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose

MEDI0382 200 μg

Intervention Type DRUG

Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose

MEDI0382 300 μg

Intervention Type DRUG

Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose

MEDI0382 50 ug

Intervention Type DRUG

Solution for injection, 1.0 mL per vial, 50 ug

Interventions

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MEDI0382 100 μg

Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose

Intervention Type DRUG

MEDI0382 200 μg

Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose

Intervention Type DRUG

MEDI0382 300 μg

Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose

Intervention Type DRUG

PlaceboA

1.0 mL liquid formulation per Vial

Intervention Type DRUG

MEDI0382 50 ug

Solution for injection, 1.0 mL per vial, 50 ug

Intervention Type DRUG

PlaceboB

Solution for injection in 1.0 mL pre-filled syringe.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Chūōku, , Japan

Site Status

Research Site

Chūōku, , Japan

Site Status

Research Site

Shinjuku-ku, , Japan

Site Status

Research Site

Shinjuku-ku, , Japan

Site Status

Research Site

Suita-shi, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5674C00001&attachmentIdentifier=178319f5-5ef4-4cca-856f-fdfb344927ae&fileName=d5674c00001_CSP_redacted.pdf&versionIdentifier=

d5674c00001 CSP redacted

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5674C00001&attachmentIdentifier=725e1184-cf38-400c-bd99-3105851a5afa&fileName=d5674c00001_SAP_redacted.pdf&versionIdentifier=

Statistical Analysis Plan (SAP) redacted

Other Identifiers

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D5674C00001

Identifier Type: -

Identifier Source: org_study_id