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

NCT00417729 | Completed Phase 4

• 1 other identifier: IRB951004/C06211
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus

Keywords

Diabetes; Acarobse; Metformin; oxidative stress; Mean amplitude Glycemic Excursion; Meal test

Outcome Measures

Primary Outcomes (2)

• 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.

  before randomisation and end of study

• Oxidative stress

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

  before randomisation and end of study

Secondary Outcomes (7)

• HbA1c

  before randomisation and end of study

• fasting glucose

  before randomisation and end of study

• Insulin response

  before randomisation and end of study

• Fasting lipids

  before randomisation and end of study

• hsCRP

  before randomisation and end of study

Study Arms (1)

acarbose, glibenclamide

ACTIVE COMPARATOR

acarbose vs. glibenclamide (background metformin therapy)

Drug: Acarbose

Interventions

Acarbose DRUG

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.

Also known as: glibenclamide

acarbose, glibenclamide

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Changhua Christian Hospital: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 24932223 DERIVED

• 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.

  PMID: 22078152 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Acarbose; Glyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Wayne H Sheu, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 1, 2007
• First Posted: January 4, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

TW (1)