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Diabetes MellitusPhase 4NCT00417729

Effects of Acarbose Versus Glibenclamide on MAGE and Oxidative Stress in Patients With Type 2 DM

A Phase 4 study testing Acarbose in people with Diabetes Mellitus, run by Taichung Veterans General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare effect of acarbose versus glibenclamide treatment on mean amplitude of glyclemic excursion and oxidative stress in diabetes individuals who failed to control their glucose by metformin therapy alone Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Acarbose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteTaiwan
Study dates
Jan 2007to Jan 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients may be included in the clinical trial only if they meet all of the following criteria:
  • Male or female outpatients;
  • Age 30 - 70 years;
  • Patients have failed to achieve glycemic control with diet, exercise and max. 2 OHA; Hemoglobin A1c level between 7.0 to 11.0 % at V1 and 7-11.5 % at V4.
  • Diagnosis of diabetes mellitus is over a minimum 3-month period;
  • All patients give written informed consent;
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  • For female patients of childbearing potential, the following criteria will be applied:
  • Using adequate contraception since last menses and will continue to use adequate contraception during the clinical trial.
  • Not lactating.
  • Negative pregnancy test (urine) within 7 days prior to the first dose of study medication. (Note: the inclusion criterion 6 does not apply to menopausal female).

Who cannot join

  • Patients will be excluded from the clinical trial for any of the following reasons:
  • Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range);
  • Patients have laboratory test abnormality (biochemistry, hematology, or urinalysis), which in the investigator's opinion might confound the clinical trial. However, patients with hyperlipemia, elevated cholesterol or triglyceride levels, or lipid metabolism disorders are eligible;
  • Use of chronic insulin therapy;
  • Patients with medical conditions that could promote lactic acidosis, such as renal or hepatic disease, unstable angina, congestive heart failure (New York Heart Association Functional Classification III and IV), or chronic obstructive pulmonary disease, e.g. respiratory insufficiency, hypoxemic condition;
  • Patients with a history of hypersensitivity to metformin hydrochloride, glibenclamide or acarbose;
  • Patients receive an investigational drug within 30 days prior to admission to the clinical trial;
  • Patients with significant alcohol, drug or medication abuse as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taichung Veterans General Hospital

    Taichung

Other trials in Taiwan

About this study

Official title: Phase 4 Study Evaluation of the Effects of Acarbose Versus Glibenclamide on Mean Amplitude of Glycemic Excursions and Oxidative Stress in Patients With Type 2 Diabetes Insufficiently Controlled by Metformin

To compare effect of acarbose versus glibenclamide treatment on mean amplitude of glyclemic excursion and oxidative stress in diabetes individuals who failed to control their glucose by metformin therapy alone

Read the detailed description

This is a randomised and open-label study conducted in 2 medical centers in central part of Taiwan. Type 2 diabetic outpatients were eligible if they were aged 30-70 years, were on mono- or dual oral antidiabetic drugs for at least 3 months, and had a glycated hemoglobin (HbA1c) value between 7.0% and 11.0%. Patients who were treated with insulin or drugs that promote weight loss, had impaired renal (serum creatinine concentration greater than 132.6 μmol/l) or liver (AST or ALT 2.5 times upper limit of normal range) function, had a history of hemoglobinopathy or chronic anemia, or women of child-bearing potential without adequate contraception were excluded. All patients provided their informed consent before they were enrolled in this study.

After an 8-week period of metformin monotherapy (500 mg t.i.d.), all patients were randomised to add on either acarbose or glibenclamide. The doses of acarbose and glibenclamide were 50 mg t.i.d. and 2.5 mg t.i.d., respectively, for 4 weeks and force-titrated to 100 mg t.i.d. and 5 mg t.i.d., respectively, for the last 12 weeks. A complete 72 hours of glucose monitoring using a continuous glucose monitoring (CGM) system and meal tolerance test (MTT) after a 10-h overnight fasting were performed before randomisation and in the end of study. Morning urine samples were collected for measurement of 8-iso prostaglandin F2α (8-iso PGF2α), a commonly used parameter of oxidative stress (13-14). The primary objectives are the changes of MAGE obtained from CGM and urinary excretion rate of 8-iso PGF2α. The secondary objectives include changes of HbA1c, lipid profiles including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, oxidized low-density lipoprotein (ox-LDL), high-sensitivity C-reactive protein (hs-CRP), total adiponectin, and high-molecular weight (HMW) adiponectin.

Being tested
Acarbose
Keywords
Diabetes, Acarobse, Metformin, oxidative stress, Mean amplitude Glycemic Excursion, Meal test
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcarboseDrug

    Also called glibenclamide

    After an 8-week period of metformin monotherapy (500 mg t.i.d.), all patients were randomised to add on either acarbose or glibenclamide. The doses of acarbose and glibenclamide were 50 mg t.i.d. and 2.5 mg t.i.d., respectively, for 4 weeks and force-titrated to 100 mg t.i.d. and 5 mg t.i.d., respectively, for the last 12 weeks.

Study groups in NCT00417729
Study groupRoleWhat they receive
acarbose, glibenclamideActive comparatoracarbose vs. glibenclamide (background metformin therapy)
Receives: Drug: Acarbose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Amplitude Glycemic Excursion

    A Medtronic MiniMed Continuous Glucose Monitoring System (Northridge, CA) was used for continuous glucose measurements on an ambulatory basis for 72 consecutive hours and MAGE calculated from the dataset.

    Measured: before randomisation and end of study

  2. Oxidative stress

    Spot urine was collected for measurement of 8-iso PGF2 alpha excretion rate.

    Measured: before randomisation and end of study

Secondary outcomes (7)

  1. HbA1c

    Glycated hemoglobin for evaluation of efficacy of glycemic control.

    Measured: before randomisation and end of study

  2. fasting glucose

    after an overnight fasting

    Measured: before randomisation and end of study

  3. Insulin response

    Evaluation by meal tolerance test. Patients were asked to consume 1.5 cans of Ensure Liquid (266 kcal/can, caloric contribution: 64% carbohydrate, 14% fat, and 22% protein) after a 10-h overnight fasting. Blood samples were drawn at 0, 10, 20, 30, 60, 90, 120, and 180 minute relative to the meal ingestion for the measurements of glucose and insulin.

    Measured: before randomisation and end of study

  4. Fasting lipids

    after an overnight fasting

    Measured: before randomisation and end of study

  5. hsCRP

    high-sensitivity C-reactive protein

    Measured: before randomisation and end of study

  6. oxLDL

    oxidized low-density lipoprotein

    Measured: before randomisation and end of study

  7. Adiponectin

    Total and high-molecular weight adiponectin

    Measured: before randomisation and end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00417729
Sponsor's protocol ID
IRB951004/C06211
Status last verified
May 2010
First submitted
1 Jan 2007
Last updated
12 May 2010
Results posted
No
Data monitoring committee
No

Publications

  • Chen PH, Tsai YT, Wang JS, Lin SD, Lee WJ, Su SL, Lee IT, Tu ST, Tseng YH, Sheu WH, Lin SY. Post-meal beta-cell function predicts the efficacy of glycemic control in patients with type 2 diabetes inadequately controlled by metformin monotherapy after addition of glibenclamide or acarbose. Diabetol Metab Syndr. 2014 May 31;6:68. doi: 10.1186/1758-5996-6-68. eCollection 2014.

    PubMed 24932223

  • Wang JS, Lin SD, Lee WJ, Su SL, Lee IT, Tu ST, Tseng YH, Lin SY, Sheu WH. Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison. Clin Ther. 2011 Dec;33(12):1932-42. doi: 10.1016/j.clinthera.2011.10.014. Epub 2011 Nov 10.

    PubMed 22078152

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acarbose in people with Diabetes Mellitus, run by Taichung Veterans General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Amplitude Glycemic Excursion (time frame: before randomisation and end of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00417729, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.

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