Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02605772
- Lead Sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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%.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description metformin+Saxagliptin Metformin 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 metformin+Saxagliptin Saxagliptin 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 acarbose+Saxagliptin Acarbose acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months acarbose+Saxagliptin Saxagliptin acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months
- Primary Outcome Measures
Name Time Method redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention baseline(0 week), week twelve HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland).
- Secondary Outcome Measures
Name Time Method 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 baseline(0 week), week twelve HOMA-β= Fasting C-Peptide × 0.27/(Fasting Plasma Glucose-3.5 HOMA-IR = 1.5 + Fasting Plasma Glucose × Fasting CPeptide/ 2800.