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Completed

NCT Number: 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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HeeYoung Lee

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glimepiride + insulin glargine (Amaryl + Lantus)

Drug
  • 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

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

Drug
  • 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

Primary outcomes

  1. Mean change in HbA1c from baseline to the last visit

    Time frame: 16 weeks

Secondary outcomes

  1. Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events

    Time frame: 16 weeks

  2. Response rate based on HbA1c and FPG levels measured at the last visit

    Time frame: 16 weeks

  3. Mean change in Lantus® dose from baseline to the last visit

    Time frame: 16 weeks

  4. Compliance

    Time frame: 16 weeks

  5. Frequency with hypoglycemic episode

    Time frame: 16weeks

  6. Adverse events

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2009
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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