SCO-792 Phase 2a in Subjects with Obese Type 2 Diabetes Mellitus on Metformin Monotherapy

Phase 2

Completed

• Conditions: Obese Type 2 Diabetes Mellitus on Metformin Monotherapy

• Registration Number: JPRN-jRCT1080224771
• Lead Sponsor: SCOHIA PHARMA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-08
• Study Completion: 2020-08-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
-The subject is capable of understanding and complying with protocol requirements.
-The subject is either male or female and aged 18 to 65 years (inclusive) at signing of informed consent.
-The subject has been treated with stable doses of metformin monotherapy (>=1000 mg/day) for at least 3 months prior to Visit 1 as determined by subject report.
-The subject has a HbA1c >=7.0% (>=53 mmol/mol) and <10.5% (<=91 mmol/mol) as assessed by the central laboratory at Visit 1 and Visit 2.
-The subject has a body mass index >=30kg/m2 as assessed by the study site at Visit 1 and Visit 2.

Exclusion Criteria

1.The subject has a history of type 1 diabetes mellitus or a history of ketoacidosis;
2.The subject has a history of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant);

Study & Design

• Study Type: Interventional
• Study Design: Not specified