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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: 50 mg SP2086; Drug: 100 mg SP2086; Drug: 200 mg SP2086; Drug: 100 mg Sitagliptin

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablets(n=4),once daily for 84 days
Experimental: 50 mg SP2086	Drug: 50 mg SP2086; Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
Experimental: 100 mg SP2086	Drug: 100 mg SP2086; Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
Experimental: 200 mg SP2086	Drug: 200 mg SP2086; Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
Active Comparator: 100 mg Sitagliptin	Drug: 100 mg Sitagliptin; Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change from baseline in HbA1c at 12 week	baseline, week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 21, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Phase II; monotherapy; Sp2086
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: HR-SP-201