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CompletedNCT00663884GLORIAUpdated Mar 30, 2012

Glufast On Insulin Glargine Trial in Type 2 DM

A Phase 4 interventional study of Mitiglinide and Voglibose in Diabetes Mellitus, Type 2, sponsored by JW Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-30.

Sponsored by JW Pharmaceutical · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • diabetes mellitus, Type 2
  • mitiglinide
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 167 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    M

    Mitiglinide

    Drug: Mitiglinide

  • Active comparator
    V

    Voglibose

    Drug: Voglibose

Interventions

  • DrugMitiglinide

    mitiglinide 10mg three times a day before a meal

    Also known as: Glufast

  • DrugVoglibose

    voglibose 0.2mg three times a day before a meal

    Also known as: Basen

06

What researchers measure

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

07

Study locations

1 site
  • The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
    Seoul, 137-701, Korea, Republic of
08

References and documents

Publications

  • Son JW, Lee IK, Woo JT, Baik SH, Jang HC, Lee KW, Cha BS, Sung YA, Park TS, Yoo SJ, Yoon KH. A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes. Endocr J. 2015;62(12):1049-57. doi: 10.1507/endocrj.EJ15-0325. Epub 2015 Sep 25. PubMed 26411328 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00663884
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Apr 22, 2008
Start date
Feb 2008
Primary completion
Jul 2009
Completion
Sep 2009
Last update
Mar 30, 2012

Study contacts

Kun-ho Yoon
study chair · The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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