Completed PHASE4 INTERVENTIONAL 2-arm NCT00913367

Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus

A Multi-center, Open, Randomized, Parallel-group, 2 Arm Study to Compare the Efficacy and Safety of Amaryl®M 1/500mg Twice Daily Versus Amaryl® 4mg Both in Combination With Lantus® Once-daily Regimen in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control

Sponsor: Handok Inc.

Conditions Type 2 Diabetes Mellitus

Interventions glimepiride + insulin glargine (Amaryl + Lantus) glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)

Updated 7 times since 2017 Last updated: Mar 26, 2013 Started: May 31, 2009 Primary completion: Nov 30, 2010 Completion: Nov 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00913367, this PHASE4 trial focuses on Type 2 Diabetes Mellitus and remains completed. Sponsored by Handok Inc., it has been updated 7 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jul 2019 — Jan 2021 [monthly]

Completed PHASE4

▶ Show 2 earlier versions

Jun 2018 — Jul 2019 [monthly]

Completed PHASE4
Jan 2017 — Jun 2018 [monthly]

Completed PHASE4

First recorded

May 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Handok Inc.

Data source: Handok Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Seoul, South Korea