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Diabetes Mellitus, Type 2Phase 4GLORIANCT00663884

Glufast On Insulin Glargine Trial in Type 2 DM

A Phase 4 study testing Mitiglinide and Voglibose in people with Diabetes Mellitus, Type 2, run by JW Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Mitiglinide and Voglibose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteSouth Korea
Study dates
Feb 2008to Sep 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

    Seoul, 137-701

Other trials in South Korea

About this study

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

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.

Being tested
Mitiglinide, Voglibose
Keywords
diabetes mellitus, Type 2, mitiglinide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitiglinideDrug

    Also called Glufast

    mitiglinide 10mg three times a day before a meal

  • VogliboseDrug

    Also called Basen

    voglibose 0.2mg three times a day before a meal

Study groups in NCT00663884
Study groupRoleWhat they receive
MExperimentalMitiglinide
Receives: Drug: Mitiglinide
VActive comparatorVoglibose
Receives: Drug: Voglibose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of HbA1c before and after administration of test drug

    Measured: 20 weeks

Secondary outcomes (4)

  1. Change of self-monitoring of blood glucose before and after administration of test drug

    Measured: 20 weeks

  2. Change of insulin dose before and after administration of test drug

    Measured: 20 weeks

  3. Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)

    Measured: 20 weeks

  4. Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJul 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00663884
Sponsor's protocol ID
CWP-KAD-402
Acronym
GLORIA
Status last verified
Mar 2012
First submitted
18 Apr 2008
Last updated
30 Mar 2012
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mitiglinide and Voglibose in people with Diabetes Mellitus, Type 2, run by JW Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of HbA1c before and after administration of test drug (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00663884, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.

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