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Completed

NCT Number: NCT00663884

Glufast On Insulin Glargine Trial in Type 2 DM

We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The type 2 diabetic patients aged between 30 and 70
  • The patients whose Hb1Ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
  • Outpatients whose BMI is between 21 and 40 kg/㎡
  • The patients who consented to participate in the clinical study in writing

Exclusion criteria

  • The patients who have been using insulin formulation except insulin glargine
  • The patients whose fasting blood glucose is over 270 mg/dL
  • The patients whose C-peptide is under 1ng/ml on an empty stomach
  • The patients who was surgically operated of gastrointestinal tract
  • The patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
  • The patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
  • The patients with unstable angina or acute myocardial infarction occurred within 3months
  • The patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmHg despite drug treatment
  • The patients who have a life-threatening disease such as cancer or severe infection
  • The patients with a history of drug allergy
  • Pregnant or breast feeding or the women who are likely to be pregnant
  • The patients who need oral or parenteral corticosteroids
  • The patients who were judged to be unsuitable to the clinical study by other reasons

Treatment and study plan

Mitiglinide

Drug

mitiglinide 10mg three times a day before a meal

Other names: Glufast

Voglibose

Drug

voglibose 0.2mg three times a day before a meal

Other names: Basen

Primary outcomes

  1. Change of HbA1c before and after administration of test drug

    Time frame: 20 weeks

Secondary outcomes

  1. Change of self-monitoring of blood glucose before and after administration of test drug

    Time frame: 20 weeks

  2. Change of insulin dose before and after administration of test drug

    Time frame: 20 weeks

  3. Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)

    Time frame: 20 weeks

  4. Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Prospective, Randomized and Multi-center Clinical Study to Evaluate Efficacy and Safety of Combination Therapy of Mitiglinide or Voglibose With Long-acting Insulin in Type 2 Diabetic Patients

Acronym: GLORIA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
Mar 30, 2012

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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