Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT01703637
• Date of registration: 06/10/2012
• Prospective Registration: No
• Primary sponsor: Lin Liao
• Public title: Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin
• Scientific title: A Multicenter, Randomized, Double-Blind Comparative Study of Efficacy,Tolerance and Safety Between Sitagliptin ,Vildagliptin and Saxagliptin After 12-week Monotherapy in Drug-naive Adult Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: October 2012
• Target sample size: 300
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT01703637
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Lin Liao, MD
• Affiliation: Qianfoshan Hospital

• Name: Lin Liao, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- signed the informed consent

- diagnosed with T2DM

- women of childbearing potential were required to have a negative urine; pregnancy
test,and agreed to use adequate contraception throughout the; study and for up to 4
weeks after completion

- glycosylated hemoglobin ranged in 6.5-9.5%

Exclusion Criteria:

- patients in pregnancy or lactation period

- ever received any kind of oral Hypoglycemic drug in recent 3 months

- patients were currently receiving treatment with a cytochrome P450 3A4 inducer or
depressor,a systemic corticosteroid,or a human immunodeficiency virus anti-viral
medication

- gastrointestinal surgery that could affect drug absorption

- patients with haemoglobinopathy or rapidly progressing renal disease, or autoimmune
skin disorder

- a recent history of alcohol or drug abuse within the past 12 months

- any contraindication listed in the package inserts of the study drugs

- a history of acute or chronic Pancreatitis or currently

- type 1 diabetes; a history of diabetic ketoacidosis or hyperosmolar nonketonic coma

- New York Heart Association class III or IV congestive heart failure; left ventricular
ejection fraction = 40%; a major cardiovascular event within the past 6 months

- significant abnormal liver function, defined as aspartate aminotransferase or alanine
aminotransferase > 2 times the upper limit of normal or total bilirubin >34 µmol/L (>
2 mg/dL); or a history of positive serologic evidence of infectious liver disease

- clinical signs or symptoms of active liver disease and/or significant abnormal liver
function

- patients with any clinically significant abnormality identified on physical
examination, electrocardiogram (ECG), or laboratory tests that, in the judgment of
the investigator, would compromise the patients' safety or successful participation
in the clinical study

- fasting plasma glucose level > 13.3mmol/l

- creatinine clearance rate = 90ml/min



Age minimum: 18 Years
Age maximum: 78 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Saxagliptin

Drug: Sitagliptin

Drug: Vildagliptin

Primary Outcome(s)

Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Change From Baseline in 2-hour Postprandial Insulin at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Body Weight at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Fasting Plasma Lipids at Week 12 [Time Frame: Baseline and Week 12]

The side effect of each drug. [Time Frame: Baseline to week 12]

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [Time Frame: Baseline to Week 12]

Change From Baseline in abdominal perimeter at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Fasting Insulin at Week 12 [Time Frame: Baseline to Week 12]

Change From Baseline in 2-hour Postprandial Glucagon at Week 12 [Time Frame: Baseline and Week 12]

The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12 [Time Frame: Baseline and Week 12]

Change From Baseline in Fasting Glucagon at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in 2-hour Postprandial Glucose at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

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Source(s) of Monetary Support

Please refer to primary and secondary sponsors