Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before and after the interventions.

Detailed Description
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Participants coming on study will be assigned to two groups：Acarbose+Saxagliptin and Metformin+Saxagliptin. It may take 1 weeks to be stabilize to a standardized dose, and then the investigators will follow-up the patients for 3 months.During the period,patients will be asked to come back to the investigators center to receive the related examination every month. The investigators will detect HbA1c，fasting and postprandial C-peptide before and after the interventions.

Official Title
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A Randomized, Non-inferiority, Open-label Clinical Trial to Evaluate the Safety and Efficacy of GAcarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes in Chinese

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Acarbose
* Drug: Metformin
* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed type 2 diabetes mellitus（course of disease less than one year） who has not receive drug treatment. T2DM patients who has not receive drug treatment for three months at least. HbA1c for 7.5-10%. Exclusion Criteria: New or worsening signs or symptoms of coronary heart disease Medical history of active liver disease and kidney disease Poorly controlled hypertension（systolic blood pressure>160mmHg or diastolic blood pressure>95mmHg） A clinically important hematological disorder A history of intolerance or hypersensitivity or any contraindication to study medications (including saxagliptin, metformin, acarbose) Is pregnant or breast feeding or is expecting to conceive or donate eggs A medical history of drug abuse Can not be followed -up on time Endocrinological diseases（eg： hyperthyroidism、hypothyroidisn and cushing syndrom） Gastrointestinal diseases Mental disorser Hypoxic disease

Ages Eligible for Study
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Minimum Age: 20 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin+Saxagliptin<br>metformin 0.5g tablet Saxagliptin 5mg tablet metformin 0.5g three times a day for three months Saxagliptin 5mg one time a day for three months | Drug: Metformin<br>* group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg<br>* Other names: Glucophage;Drug: Saxagliptin<br>* group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg<br>* Other names: ONGLYZA;|
| Experimental: acarbose+Saxagliptin<br>acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months | Drug: Acarbose<br>* group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg<br>* Other names: Glucobay;Drug: Saxagliptin<br>* group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg<br>* Other names: ONGLYZA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention | HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland). | baseline(0 week), week twelve | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study |  | baseline(0 week), week twelve | 
| Difference of Homeostasis model assessment of insulin resistance (HOMA-IR) and Homeostasis model assessment beta cell function index (HOMA-β) between two groups after three months intervention | HOMA-β= Fasting C-Peptide × 0.27/(Fasting Plasma Glucose-3.5 HOMA-IR = 1.5 + Fasting Plasma Glucose × Fasting CPeptide/ 2800. | baseline(0 week), week twelve |