MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus

Detailed Description
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This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).

Official Title
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A Multi-center, Active Controlled, Randomized, Double-blinded, Parallel, Phase IV Study to Evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared With Sitagliptin in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Anagliptin BID Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks. 6.5% ≤HbA1c< 8.5% Agreed Therapeutic Lifestyle change during the study period Obtained Informed Consent Form Exclusion Criteria: Type 1 diabetes mellitus, History of intestinal obstruction NYHA class III to IV congestive heart failure, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 X upper limit of normal (ULN) or Total bilirubin > 3 X ULN Creatinine clearance (CrCl)* < 50 mL/min Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN Allergic history for Anagliptin 또는 sitagliptin Being pregnant or nursing or suspected of being pregnant, or History of participation in other clinical studies in the preceding 3 months.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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
Interventional Model Description: A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anagliptin arm<br>Anagliptin 100 mg twice a day | Drug: Anagliptin BID Treatment<br>* Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks<br>* Other names: Sitagliptin QD Treatment;|
| Active Comparator: Sitagliptin 100mg<br>Sitagliptin 100mg once a day | Drug: Anagliptin BID Treatment<br>* Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks<br>* Other names: Sitagliptin QD Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Improving Glycemic Variability | Mean amplitude of glycemic excursion (MAGE) | 3 days after 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average nighttime (18:00 07:59) blood glucose change after 12 weeks compared to baseline | after 12 weeks compared to baseline in the test group and the control group | after 12 weeks treatment |