Clinical trial NCT02605772: Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention
timeFrame: baseline(0 week), week twelve
Secondary outcomes:
measure: Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study
timeFrame: baseline(0 week), week twelve
measure: 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
timeFrame: baseline(0 week), week twelve
Other outcomes:
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