A phase II confirmatory study of SMP-862 monotherapy in patients with type 2 diabetes mellitus

Phase 2

• Conditions: Type 2 diabetes mellitus patients whose blood glucose levels are not adequately controlled by diet and exercise therapies

• Registration Number: JPRN-jRCT2080220088
• Lead Sponsor: Dainippon Sumitomo Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with type 2 diabetes mellitus who satisfy the following inclusion criteria
-Patients who are undergoing only diet and exercise therapies
-Patients whose HbA1c levels are 6.5% <= HbA1c < 12.0%, and are stable over 4 weeks
-Patients aged 20 to less than 75
-Outpatients
etc.

-Patients with hepatic dysfunction
-Patients with renal dysfunction
-Patients with severe cardiovascular or pulmonary dysfunction, patients who have other conditions which are likely to be associated with hypoxemia
-Patients with a history of lactic acidosis
-Patients who are dehydrated or patients who have severe gastrointestinal disorders such as diarrhoea or vomiting which are likely to cause dehydration
etc.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified