Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on MAGE in Patients With Type 2 DM
Overview[ - collapse ][ - ]
Purpose | To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on MAGE (mean amplitude of glyclemic excursion) in Patients With Type 2 Diabetes Mellitus. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin |
Phase | Phase 4 |
Sponsor | LG Life Sciences |
Responsible Party | LG Life Sciences |
ClinicalTrials.gov Identifier | NCT01890629 |
First Received | May 24, 2013 |
Last Updated | June 27, 2013 |
Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 24, 2013 |
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Last Updated Date | June 27, 2013 |
Start Date | May 2013 |
Estimated Primary Completion Date | October 2014 |
Current Primary Outcome Measures | Mean Amplitude Glycemic Excursion [Time Frame: Change of MAGE at Week 12 from baseline] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on MAGE in Patients With Type 2 DM |
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Official Title | A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on MAGE (Mean Amplitude of Glycemic Excursions) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes |
Brief Summary | To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on MAGE (mean amplitude of glyclemic excursion) in Patients With Type 2 Diabetes Mellitus. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 69 |
Estimated Completion Date | October 2014 |
Estimated Primary Completion Date | April 2014 |
Eligibility Criteria | Inclusion Criteria: - Patients with Type 2 Diabetes Mellitus - 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 Type 1 Diabetes, Patients with Diabetic Ketoacidosis or Diabetic Coma as well as Pre-coma - 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 |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: YoungHwan Jang 82-2-6924-3158 younghj@lgls.com |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01890629 |
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Other Study ID Numbers | LG-DPCL012 |
Has Data Monitoring Committee | No |
Information Provided By | LG Life Sciences |
Study Sponsor | LG Life Sciences |
Collaborators | Not Provided |
Investigators | Principal Investigator: SE Park Kangbuk Samsung Medical centerPrincipal Investigator: BW Lee Severance HospitalPrincipal Investigator: JH Jo Seoul St. Mary's HospitalPrincipal Investigator: JH Kim Samsung Medical CenterPrincipal Investigator: JH Jung Asan Medical Center |
Verification Date | June 2013 |
Locations[ + expand ][ + ]
Severance hospital | Seoul, Korea, Republic of, 120-752 Contact: BW LeePrincipal Investigator: BW Lee Recruiting |
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