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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969357
• Other study ID #: HR-SP-201
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2013
• Last updated: October 21, 2013
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Placebo
Tablets(n=4),once daily for 84 days
• 50 mg SP2086
Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
• 100 mg SP2086
Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
• 200 mg SP2086
Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
• 100 mg Sitagliptin
Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change from baseline in HbA1c at 12 week		baseline, week 12	No
Secondary	Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels		week 12	No
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12		Baseline, Week 4, 8, 12	No
Secondary	Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12		baseline, week 4 ,12	No
Secondary	Change from baseline in Homeostasis model assessment-beta(HOMA-ß) at week 4,week12		baseline, week 4,12week	No
Secondary	Change From Baseline in lipid at Week 4, 8 and 12		baseline, week 4, 8, 12	No
Secondary	Change From Baseline in Body Weight at Week 4,8,12		baseline, Week 4, 8,12	No