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

Fifth Affiliated Hospital, Sun Yat-Sen University

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin; Drug: Acarbose; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02605772

FifthSunYetSen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

metformin+Saxagliptin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Saxagliptin

acarbose+Saxagliptin

Experimental group

Description:

acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months

Treatment:

Drug: Acarbose

Drug: Saxagliptin