A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus

November 19, 2010 updated by: Lotus Pharmaceutical
Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin secretion deficiency and insulin action defect. In this type of subjects, fasting hyperglycemia is the result of the elevated rate of basal hepatic glucose production, and it is coexisting with hyperinsulinemia.After a meal, the impaired control of hepatic glucose production by insulin and decreased insulin-mediated glucose uptake by muscle contributed nearly equally to postprandial hyperglycemia(Scheen, 1997). Type 2 diabetic subjects experience significant morbidity and mortality from microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular (cardiovascular disease, stroke, and peripheral vascular disease) complications. The appropriate treatment and good glycemic control of diabetes is therefore important and necessary (Vaag, 2006). Evidences suggest that combination therapy using oral antidiabetic agents with different mechanisms of action may be more effective in achieving and maintaining target blood glucose level (Turner et al., 2005).There are five classes of oral antihyperglycemic agents (sulfonylureas, biguanides, α- ucosidase inhibitors, thiazolidinediones and meglitinides) currently available to improve glycemic control in subjects with type 2 diabetes, each of which works through a different mechanism of action. Metformin, a biguanide which has insulin-sensitizing properties, can be used alone or in combination with other classes of agents. Metformin is the currently the first-choice treatment in subjects with diagnosed type 2 diabetic subjects and obesity, characterized by insulin-resistance. Metformin also provides reduction of body weight and ameliorates lipid abnormalities and is thought to be related to a reduction in hepatic gluconeogenesis (Hundal & Inzucchi, 2003).Acarbose, the α-glucosidase inhibitor, is approved for the treatment of type 2 diabetes, and first approved for prediabetes treatment (Chiasson et al., 1994; Breuer, 2003; Chiasson et al., 2002). The drug was launched worldwide as a type 2 diabetes monotherapy and combination therapy in 1990 which has proven efficacious as first-line therapy (Coniff et al., 1995) and in combination with sulfonylureas or insulin (Kelley et al., 1998). Acarbose and metformin are both associated with beneficial effects on hyperglycemia, hyperinsulinemia, body weight, and, in some studies,triglyceride levels (Krentz et al., 1994). Because these factors are part of a cluster of risk factors for cardiovascular disease, combining the two drugs may be useful. In long-term clinical studies, acarbose has shown a favorable safety profile (Hasche et al., 1999).In combination with metformin, acarbose has been shown to improve long-term glycemic control (Rosenstock et al., 1998; Halimi et al., 2000). This study was conducted as a further vestigation into the efficacy and safety of concurrent use of acarbose and metformin in type 2 diabetes mellitus subjects.Lotus Pharmaceutical Co., Ltd. intends to initiate Phase III program to investigate assess the efficacy and safety of metformin in combination with acarbose for type 2 diabetes mellitus subjects considered inadequately blood glucose control. Since combination tablet of acarbose and metformin has not yet been approved by the Taiwan DOH, this study is conducted to evaluate the efficacy and safety of combination tablet of acarbose and metformin in the treatment of type 2 diabetes mellitus subjects in Taiwan. Acarbose is chosen as an active-comparator.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects may be included in the study only if they meet all of the following criteria:

    1. Male or female subjects aged ≥ 20 and ≤ 80 years old;
    2. Subject with type 2 diabetes mellitus;
    3. Subject with documented HbA1c ≥ 7 % and ≤ 10 % within 3 months prior study and at screening;
    4. Body mass index < 35 kg/m2;
    5. Subject is willing and able to comply with study procedures and sign informed consent.

Exclusion Criteria:

  • Subjects will be excluded from the study for any of the following reasons:

    1. Subject with type 1 diabetes or secondary diabetes;
    2. Subject with history or concurrent ketonuria or other acidosis;
    3. Subject with type 2 diabetes mellitus treated with high dose of sulfonylurea (gliclazide > 320 mg, glibenclamide > 20 mg, glimepiride > 6 mg, and glipizide > 20 mg) or with biguanides (metformin > 2000 mg), or of α-glucosidase inhibitors (acarbose > 300 mg), or with meglitinides (repaglinide > 6 mg and nateglinide > 360 mg), thiazolidinedione (rosiglitazone > 4 mg, pioglitazone > 30 mg) or with insulin;
    4. Subject with gastrointestinal disease that may interfere with absorption of the investigational products at discretion of investigator, including but are not limited to malabsorption syndromes and gastric ulcer;
    5. Subject with kidney function impairment defined as serum creatinine > 1.5 mg/dL for male, serum creatinine > 1.4 mg/dL for female, or liver function impairment defined as ALT > 3 X ULN, or AST > 3 X ULN;
    6. Subject with history of drug or alcohol abuse within the past 1 year;
    7. Subject who have been diagnosed with acute myocardial infarction or cardiac failure within 6 months preceding screening;
    8. Subject with hypersensitivity to acarbose and/or metformin products;
    9. Subject with active cancer, defined as ongoing, progressing cancer, or < 5 years of stable disease;
    10. Hemoglobin values < 10 gm/dl for females or <11 gm/dl for males;

    11. Female subject of childbearing potential who:

      • is lactating; or · has positive urine pregnancy test at Visit 1; or
      • refuse to adopt reliable method of contraception during the study;
    12. Subject is contraindicated to acarbose and/or metformin treatment;
    13. Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
    14. Subject who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine,immune, neurological, or hematological disease as determined by the clinical judgment of the investigator.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Acarbose
Drug: Acarbose
Acarbose 50 mg, per orem, thrice daily
Experimental: Metformin/Acarbose
Drug: Metformin/Acarbose
Metformin HCl 500 mg plus Acarbose 50 mg Tablets, per orem, thrice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The changes from baseline in HbA1c to the end of treatment period
Time Frame: -4 weeks, 0 week, 8 weeks, 12 weeks, 16 weeks
-4 weeks, 0 week, 8 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
the change from baseline to the end of treatment in FBG, PBG, lipid profiles, and body weight. The safety evaluation will include: 1) Adverse events; 2) Laboratory data; 3) Physical examination; 4) Vital signs; 5) 12- lead ECG
Time Frame: -4 weeks, 0 week, 4 weeks, 8 weeks, 12 weeks, 16 weeks
-4 weeks, 0 week, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lotus Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCCD09013B

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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Drug Interventions

Conditions

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