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

March 26, 2013 updated by: Handok Inc.

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

The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM. Among them, sulfonylurea and metformin are well-established first-line OADs. However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs. Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure. But, it still remains unclear which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

so, this study we will be able to verify which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 20 years old with type 2 DM
  • Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.
  • 7%<HbA1c<11 % at screening
  • 21 kg/m2 ≤ BMI ≤ 30 kg/m2
  • Patents who need insulin add-on therapy based on investigator's discretion
  • Patients who would give the informed consent
  • Patients who can perform SMBG and record the data on the patient's diary

Exclusion Criteria:

  • History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
  • Pregnant or lactating females
  • History of drug or alcohol abuse
  • Patients with known hypersensitivity to glimepiride, metformin HCL or insulin
  • Night-shift workers
  • Patients who are under insulin therapy at screening
  • Treatment with any investigational products in the last 3 months before screening
  • Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision
  • Patients with serum creatinine level > 1.5 mg/dl in male and > 1.4 mg/dl in female
  • Patients with ALT or AST > 3x ULN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amaryl group
Drug: glimepiride + insulin glargine (Amaryl + Lantus)
  • Amaryl® 4 mg at breakfast + Lantus® at dinner
  • The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast
Other Names:
  • Amaryl
  • Lantus injection solostar
Experimental: Amaryl M group
Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)
  • Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner
  • The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast
Other Names:
  • Amaryl M
  • Lantus injection solostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in HbA1c from baseline to the last visit
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events
Time Frame: 16 weeks
16 weeks
Response rate based on HbA1c and FPG levels measured at the last visit
Time Frame: 16 weeks
16 weeks
Mean change in Lantus® dose from baseline to the last visit
Time Frame: 16 weeks
16 weeks
Compliance
Time Frame: 16 weeks
16 weeks
Frequency with hypoglycemic episode
Time Frame: 16weeks
16weeks
Adverse events
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Investigators

  • Principal Investigator: Kang S Park, Eulji University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HANDOK2008.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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