Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)

Study Overview
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Brief Summary
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To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.

Official Title
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A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) 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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin


Participation Criteria
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Eligibility Criteria
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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 Patients with surgically induced infertility Post-menopause woman ≥45 years of age with over 2 years from the last menstruation 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemigliptin + Metformin<br>Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin<br> <br> |
| Active Comparator: Sitagliptin + Metformin<br>Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin<br> <br> |
| Active Comparator: Glimepiride + Metformin<br>Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Amplitude Glycemic Excursion |  | Change of MAGE at Week 12 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon |  | Change of Glucagon at Week 12 from baseline | 
| Active GLP-1 |  | Change of Active GLP-1 at Week 12 from baseline | 
| CRP |  | Change of CRP at Week 12 from baseline | 
| Nitrotyrosine |  | Change of nitrotyrosine at Week 12 from baseline | 
| Glycated albumin |  | Change of glycated albumin at Week 4 from baseline | 
| Fructosamine |  | Change of fructosamine at Week 4 from baseline | 
| Glucose Standard Deviation in CGMS data |  | Change of Glucose SD at Week 12 from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus