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

NCT ID: NCT02605772

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin+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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Saxagliptin

Intervention Type DRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

acarbose+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

Group Type EXPERIMENTAL

Acarbose

Intervention Type DRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Saxagliptin

Intervention Type DRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Interventions

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Acarbose

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Intervention Type DRUG

Metformin

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Intervention Type DRUG

Saxagliptin

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Intervention Type DRUG

Other Intervention Names

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Glucobay Glucophage ONGLYZA

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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liao sun

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FifthSunYetSen

Identifier Type: -

Identifier Source: org_study_id