A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: 200 mg SP2086; Drug: 100 mg Sitagliptin; Drug: Placebo; Drug: 50 mg SP2086; Drug: 100 mg SP2086

Study type: Interventional

Funder types: Industry

Identifiers

NCT01969357

HR-SP-201

Details and patient eligibility

About

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.

Enrollment: 200 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus
• Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5%
• BMI 19~35 kg/m2

Exclusion criteria

• Patient has history of type 1 diabetes mellitus
• Patient has history of ketoacidosis
• Patient has history of severe unconscious hypoglycemosis
• Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
• Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
• Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
• Patient has severe liver or kidney disease,alanine aminotransferase >2×UNL, Aspartate Aminotransferase >2×upper normal limit(UNL)；total bilirubin >2×UNL； creatinine>1.5 mg/dL (Male,132.6μmol/L) ，>1.4 mg/dL(Female，123.8μmol/L)
• Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
• Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
• Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
• Patient has history of malignancy
• Patient has history of alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

50 mg SP2086

Experimental group

Treatment:

Drug: 50 mg SP2086

100 mg SP2086

Experimental group

Treatment:

Drug: 100 mg SP2086

200 mg SP2086

Experimental group

Treatment:

Drug: 200 mg SP2086

100 mg Sitagliptin

Active Comparator group

Treatment:

Drug: 100 mg Sitagliptin