Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)
NCT ID: NCT01890629
Last Updated: 2015-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
69 participants
INTERVENTIONAL
2013-05-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemigliptin + Metformin
Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks
Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Sitagliptin + Metformin
Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks
Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Glimepiride + Metformin
Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks
Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Interventions
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Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Eligibility Criteria
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Inclusion Criteria
* adults aged ≥ 20 and aged ≤ 70 years old
* Patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with HbA1c ≥ 7.5%
* All patients give written informed consent
* Patients applicable to any one of following 3 categories
1. Patients with surgically induced infertility
2. Post-menopause woman ≥45 years of age with over 2 years from the last menstruation
3. Fertile pre-menopause woman or male patients who has consented for use of two or more contraceptive methods at least up to 14 days after final administration of the investigational product to avoid getting pregnant
Exclusion Criteria
* Patients with Gestational Diabetes Mellitus or with Secondary Diabetes
* Patients with NYHA Class III, IV Congestive Heart Failure or with Treatment-requiring Arrhythmia
* Patients with Thyroid Dysfunction whose TSH is out of normal range, requiring medication therapy
* Patients with pituitary insufficiency or hypoadrenalism
* Patients whose BMI is less than 20 Kg/m2 or exceeds 40 Kg/m2
* Patients whose Total Bilirubin level is 1.5 times higher than the upper limit of normal range and ALT/AST are \> 2.5 times higher than the upper limit of normal range
* Patients currently taking strong CYP3A4 inducers
* Patients currently taking Warfarin, Dicoumar or Digoxin
* Patients currently taking any medication from within 4 weeks before Visit 1 (screening) likely to have significant effects on glycemic control or who require to take such medication
* Patients who had taken anti-obesity drugs within 12 weeks in prior to Visit 1 (screening)
* Subject who had been treated with Insulin or GLP-1 analogue within 6 months before Visit 1 (screening)
* Patients who had participated in other clinical study in the past 3 months before Visit 1 (screening)
* Any other patients whom the investigator considers as inadequate for this study
20 Years
70 Years
ALL
No
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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SE Park
Role: PRINCIPAL_INVESTIGATOR
Kangbuk Samsung Hospital
BW Lee
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
JH Jo
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
JH Kim
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
JH Jung
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Severance hospital
Seoul, , South Korea
Countries
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Other Identifiers
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LG-DPCL012
Identifier Type: -
Identifier Source: org_study_id
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