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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin; Drug: Saxagliptin; Drug: Acarbose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Metformin; group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg; Other Names: Glucophage; Drug: Saxagliptin; group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg; Other Names: ONGLYZA
Experimental: 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	Drug: Saxagliptin; group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg; Other Names: ONGLYZA; Drug: Acarbose; group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg; Other Names: Glucobay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study		baseline(0 week), week twelve
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.	baseline(0 week), week twelve

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose; Saxagliptin
• Other Study ID Numbers: FifthSunYetSen