A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: AD-4833 30 mg; Drug: AD-4833 15 mg; Drug: Placebo

• Registration Number: NCT01686711
• Lead Sponsor: Takeda

Brief Summary

To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-31
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-18
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
• Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.

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Exclusion Criteria

• Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
• Others who are assessed to be ineligible for the study by the investigator or subinvestigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYR-322 25 mg , AD-4833 30 mg	AD-4833 30 mg	-
SYR-322 25 mg , AD-4833 15 mg	AD-4833 15 mg	-
SYR-322 25 mg , AD-4833 placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Glycosylated Hemoglobin (HbA1c)	16 weeks	Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)