Clinical trial NCT01970033: Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes
Official title: A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase III Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: SP2086
Phase III
Monotherapy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type 2 diabetes mellitus
* Patients have treated with diet/exercise at least 3 months
* 7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in

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

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week24
timeFrame: baseline, week 24
Secondary outcomes:
measure: Change From Baseline in fasting plasma glucose (FPG) at Week 24
timeFrame: Weeks 0-24
measure: Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
timeFrame: Weeks 0-24
measure: Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
timeFrame: week24
measure: Change From Baseline in A1C at Week 52
timeFrame: week 52
measure: Change From Baseline in FPG at Week 52
timeFrame: week 52
measure: Change From Baseline in lipid at Week 4、8、12、24、38、52
timeFrame: Week 4、8、12、24、38、52
measure: Change From Baseline in Body Weight at Week 4,8,12、24、38、52
timeFrame: Week 4、8、12、24、38、52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Changyu Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: