- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663884
Glufast On Insulin Glargine Trial in Type 2 DM (GLORIA)
March 28, 2012 updated by: JW Pharmaceutical
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
167
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 137-701
- The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: M
Mitiglinide
|
mitiglinide 10mg three times a day before a meal
Other Names:
|
Active Comparator: V
Voglibose
|
voglibose 0.2mg three times a day before a meal
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of HbA1c before and after administration of test drug
Time Frame: 20 weeks
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of self-monitoring of blood glucose before and after administration of test drug
Time Frame: 20 weeks
|
20 weeks
|
Change of insulin dose before and after administration of test drug
Time Frame: 20 weeks
|
20 weeks
|
Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)
Time Frame: 20 weeks
|
20 weeks
|
Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kun-ho Yoon, The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
April 18, 2008
First Submitted That Met QC Criteria
April 21, 2008
First Posted (Estimate)
April 22, 2008
Study Record Updates
Last Update Posted (Estimate)
March 30, 2012
Last Update Submitted That Met QC Criteria
March 28, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWP-KAD-402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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