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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02605772
• Other study ID #: FifthSunYetSen
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 12, 2015
• Last updated: November 16, 2015
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Acarbose
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
• Metformin
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
• Saxagliptin
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline(0 week), week twelve	No
Secondary	Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study		baseline(0 week), week twelve	Yes
Secondary	Difference of Homeostasis model assessment of insulin resistance (HOMA-IR) and Homeostasis model assessment beta cell function index (HOMA-ß) between two groups after three months intervention	HOMA-ß= Fasting C-Peptide × 0.27/(Fasting Plasma Glucose-3.5 HOMA-IR = 1.5 + Fasting Plasma Glucose × Fasting CPeptide/ 2800.	baseline(0 week), week twelve	Yes