Clinical trial NCT01969357: A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes
Official title: A Multicenter Randomized, Double-blind, Placebo and Positive Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Sp2086
Phase II
monotherapy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
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 explore the effective dose range of SP2086 in Patients with type 2 diabetes.


Eligibility criteria: 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

Primary outcomes:
measure: the change from baseline in HbA1c at 12 week
timeFrame: baseline, week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
timeFrame: week 12
measure: Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12
timeFrame: Baseline, Week 4, 8, 12
measure: Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12
timeFrame: baseline, week 4 ,12
measure: Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12
timeFrame: baseline, week 4,12week
measure: Change From Baseline in lipid at Week 4, 8 and 12
timeFrame: baseline, week 4, 8, 12
measure: Change From Baseline in Body Weight at Week 4,8,12
timeFrame: baseline, Week 4, 8,12
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: