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

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Treatments: Acarbose; Metformin; Saxagliptin

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