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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00663884
First received: April 18, 2008
Last updated: March 28, 2012
Last verified: March 2012

April 18, 2008
March 28, 2012
February 2008
July 2009   (final data collection date for primary outcome measure)
Change of HbA1c before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00663884 on ClinicalTrials.gov Archive Site
  • Change of self-monitoring of blood glucose before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Change of insulin dose before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Glufast On Insulin Glargine Trial in Type 2 DM
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Mitiglinide
    mitiglinide 10mg three times a day before a meal
    Other Name: Glufast
  • Drug: Voglibose
    voglibose 0.2mg three times a day before a meal
    Other Name: Basen
  • Experimental: M
    Mitiglinide
    Intervention: Drug: Mitiglinide
  • Active Comparator: V
    Voglibose
    Intervention: Drug: Voglibose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
September 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00663884
CWP-KAD-402
Yes
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Study Chair: Kun-ho Yoon The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
JW Pharmaceutical
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP