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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Acarbose

Metformin

Saxagliptin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

metformin+Saxagliptin

acarbose+Saxagliptin

Arm 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

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

Outcomes

Primary Outcome Measures

redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention

HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland).

Secondary Outcome Measures

Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study

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

HOMA-β= Fasting C-Peptide × 0.27/(Fasting Plasma Glucose-3.5 HOMA-IR = 1.5 + Fasting Plasma Glucose × Fasting CPeptide/ 2800.

Full Information

NCT ID

NCT02605772

First Posted

November 12, 2015

Last Updated

November 16, 2015

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT02605772

Brief Title

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

Official Title

A Randomized, Non-inferiority, Open-label Clinical Trial to Evaluate the Safety and Efficacy of GAcarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes in Chinese

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin+Saxagliptin

Arm Type

Experimental

Arm 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

Arm Title

acarbose+Saxagliptin

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

Glucobay

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saxagliptin

Other Intervention Name(s)

ONGLYZA

Intervention Description

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

Primary Outcome Measure Information:

Title

redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention

Description

HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland).

Time Frame

baseline(0 week), week twelve

Secondary Outcome Measure Information:

Title

Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study

Time Frame

baseline(0 week), week twelve

Title

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

Description

HOMA-β= Fasting C-Peptide × 0.27/(Fasting Plasma Glucose-3.5 HOMA-IR = 1.5 + Fasting Plasma Glucose × Fasting CPeptide/ 2800.

Time Frame

baseline(0 week), week twelve

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

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

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