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Glufast On Insulin Glargine Trial in Type 2 DM (GLORIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663884
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):
JW Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Mitiglinide Drug: Voglibose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: M
Drug: Mitiglinide
mitiglinide 10mg three times a day before a meal
Other Name: Glufast

Active Comparator: V
Drug: Voglibose
voglibose 0.2mg three times a day before a meal
Other Name: Basen

Primary Outcome Measures :
  1. Change of HbA1c before and after administration of test drug [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00663884

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Korea, Republic of
The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
JW Pharmaceutical
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Study Chair: Kun-ho Yoon The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: JW Pharmaceutical Identifier: NCT00663884     History of Changes
Other Study ID Numbers: CWP-KAD-402
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by JW Pharmaceutical:
diabetes mellitus, Type 2

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances