VISA-T2DM: Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02999841

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2 ≤ body mass index ≤ 30kg/m2).

50 participants per arm (acarbose & lifestyle combination / vildagliptin & lifestyle combination), using abdominal computed tomography scans and other methods to evaluate the effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity patients with newly diagnosed type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Obesity	Drug: Acarbose Drug: Vildagliptin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Overweight and Obesity Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Randomized Control Study

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Acarbose	Drug: Acarbose 1-2 week: 50mg tid; 3-24 week: 100mg tid. Other Names: Glucobay (Acarbose Tablets)
Active Comparator: Group B Vildagliptin	Drug: Vildagliptin 1-24 week: 50mg bid Other Names: Galvus (Vidagliptin Tablets)

Arm

Intervention/Treatment

Experimental: Group A

Acarbose

Drug: Acarbose

1-2 week: 50mg tid; 3-24 week: 100mg tid.

Other Names:

Glucobay (Acarbose Tablets)

Active Comparator: Group B

Vildagliptin

Drug: Vildagliptin

1-24 week: 50mg bid

Other Names:

Galvus (Vidagliptin Tablets)

Outcome Measures

Primary Outcome Measures

Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks. [24 weeks]

Secondary Outcome Measures

Change of body weight in kilograms measured by investigators from baseline to 24 weeks. [24 weeks]
Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks. [24 weeks]
Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks. [24 weeks]
Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks. [24 weeks]
Change of hemoglobin A1c in percents from baseline to 24 weeks. [24 weeks]
Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks. [24 weeks]
Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks. [24 weeks]
Change of triglyceride in millimols per liter from baseline to 24 weeks. [24 weeks]
Change of total cholesterol in millimols per liter from baseline to 24 weeks. [24 weeks]
Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks. [24 weeks]
Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks. [24 weeks]
Change of insulin in international units per liter from baseline to 24 weeks. [24 weeks]
Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients was diagnosed within the past 12 months with type 2 diabetes patients (WHO, 1999 criteria ).
Not received oral anti-diabetic drugs or has been on short-term(1month) treatment that had been discontinued 3 months before enrollment.
30 ≤ Age ≤ 70 years old, male or female.
HbA1c between 7% and 9% (7.0% ≤ HbA1c ≤9.0%).
24 ≤ BMI ≤ 30 kg/m2.
Written Informed consent.

Exclusion Criteria:

Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM.
Those who can not tolerate AGI or who is suffering GI disease.
Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia.
Known or suspected allergy to trial product(s) or related products.
Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
Impaired liver function, defined as ALT≥2 or AST≥ 2 times upper referenced limit times upper normal limit.
Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection.
Endocrine diseases (hypo thyroidism, hyperthyroidism,Cushing's syndrome).
Uncontrolled hypertension(SBP≥180mmHg and/or DBP≥100mmHg).
Diabetic ketoacidosis; or hyperosmolar non-ketotic coma.
Concomitant treatment which influences blood glucose and bodyweight.
Impaired renal function(Cr≥ 1.5 mg/dl in male or Cr≥1.4 mg/dl in female).
Mental disorders; drug or other substance misuse.
Participation in any drug clinical trials during the past 3 months before enrolment.