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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
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Mitiglinide
Drug: Voglibose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Change of HbA1c before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 167
Study Start Date: February 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: M
Mitiglinide
 Drug: Mitiglinide
mitiglinide 10mg three times a day before a meal
Other Name: Glufast
Active Comparator: V
Voglibose
 Drug: Voglibose
voglibose 0.2mg three times a day before a meal
Other Name: Basen

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663884

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

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00663884     History of Changes
Other Study ID Numbers: CWP-KAD-402
Study First Received: April 18, 2008
Last Updated: March 28, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by JW Pharmaceutical:
diabetes mellitus, Type 2
mitiglinide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Mitiglinide
Voglibose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013