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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Acarbose; Drug: Vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02999841

2119000273

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Experimental group

Description:

Acarbose

Treatment:

Drug: Acarbose

Group B

Active Comparator group

Description:

Vildagliptin

Treatment:

Drug: Vildagliptin