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Clinical Trials/JPRN-jRCT2080223014
JPRN-jRCT2080223014
Unknown
Phase 2

A phase 2, randomized, double-blind, dose finding study of DS-8500a in Japanese patients with type 2 diabetes mellitus

DAIICHISANKYO Co.,Ltd.0 sites335 target enrollmentNovember 13, 2015
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
DAIICHISANKYO Co.,Ltd.
Enrollment
335
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 13, 2015
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
DAIICHISANKYO Co.,Ltd.

Eligibility Criteria

Inclusion Criteria

  • •Main Inclusion Criteria;
  • •1\)Patients aged \>\= 20 years
  • •2\)Japanese patients with type 2 diabetes mellitus
  • •3\)Patients who have \>\= 7\.0% and \< 10\.0% HbA1c

Exclusion Criteria

  • •Main Exclusion Criteria;
  • •\-Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
  • •\-Patients receiving or requiring treatment with insulin
  • •\-Patients with a body mass index (BMI) of \< 18\.5 kg/m2 or \>\= 35\.0 kg/m2
  • •\-Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR] of \< 45 mL/min per 1\.73 m2\) or clinically significant renal disease
  • •\-Patients with fasting plasma glucose \>\= 240 mg/d

Outcomes

Primary Outcomes

Not specified

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