Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGAcarbose
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
DRUGMetformin
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
DRUGSaxagliptin
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed