Vildagliptin on glycemic control in newly diagnosed type 2 diabetes in the short-term insulin pump therapy and remission: a prospective, randomized, open, controlled single-center clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002553

Enrollment

Unknown

Registered

2012-09-26

Start date

2012-10-24

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Group A:CSII monotherapy

B:CSII + Vildagliptin 50mg bid

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed type 2 diabetes [1999 World Health Organization (WHO) diagnostic criteria, duration of <12 months; insulin autoantibodies, glutamic acid decarboxylase antibodies, islet cell antibodies were negative; never used oral hypoglycemic agents, lipid-loweringdrugs or insulin treatment; 2. Fasting plasma glucose (FPG) <15mmol/L, and (or) HbA1c 7-10.0%; 3. Between the ages of 18-75 years old, male or female, body mass index (BMI) 20-35kg/m2; 4. No high blood pressure, or hypertension patients using antihypertensive drugs, blood pressure <=150/90mmHg; 5. Serum creatinine <=1.5mg/dL, alanine aminotransferase <=2.5 times the upper limit of normal, total bilirubin <=1.5 times normal,Ceiling triglycerides <=4.5mmol/L; 6. Subjects fertility, or agree to use contraception in the course of the study; 7. Able and willing to carry out the monitoring of blood glucose; 8. Understand test the whole process, and is willing to sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes; 2. Acute complications of diabetes or with severe chronic complications (such as the proliferation of retinal lesions, etc.); 3. With severe infection control, or the presence of anemia and hemoglobin 160/100mmHg; 8. Edema in patients with or accompanied by massive proteinuria> 1g/24h; 9. Associated with other systemic diseases (such as cardiac insufficiency, cerebrovascular accident, etc.), it is difficult to complete the test; 10. Mental or communication barriers, the subjects were unable to understand the nature of the research or the adjustment of blood glucose monitoring and treatment programs; 11. Uncooperative subjects can not follow-up, or researchers judge may be difficult to complete the study.

Design outcomes

Primary

Measure	Time frame
HbA1c;Blood glucose;Insulin;c-peptide;incidence of hypoglycemia;live function;renal function;8-iso-PGF2 alpha;beta-CTX;N-MID;Total-P1N;	—

Countries

China

Contacts

Public ContactYaoming Xue

yaomingxue@126.com+86 020 61641631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026