Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on MAGE in Patients With Type 2 DM | RxWiki

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.
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
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	Glucagon [Time Frame: Change of Glucagon at Week 12 from baseline] [Designated as safety issue: No] Active GLP-1 [Time Frame: Change of Active GLP-1 at Week 12 from baseline] [Designated as safety issue: No] CRP [Time Frame: Change of CRP at Week 12 from baseline] [Designated as safety issue: No] Nitrotyrosine [Time Frame: Change of nitrotyrosine at Week 12 from baseline] [Designated as safety issue: No] Glycated albumin [Time Frame: Change of glycated albumin at Week 4 from baseline] [Designated as safety issue: No] Fructosamine [Time Frame: Change of fructosamine at Week 4 from baseline] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on MAGE in Patients With Type 2 DM
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)	Experimental: Gemigliptin + Metformin Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks Active Comparator: Sitagliptin + Metformin Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks Active Comparator: Glimepiride + Metformin Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
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
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

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