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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: 100 mg Sitagliptin; Drug: Placebo; Drug: 50 mg SP2086; Drug: 100 mg SP2086; Drug: 200 mg SP2086

• Registration Number: NCT01969357
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Status Verified: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-21
• Last Update Submitted: 2013-10-21
• Study First Posted: 2013-10-25
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 mg Sitagliptin	100 mg Sitagliptin	-
Placebo	Placebo	-
50 mg SP2086	50 mg SP2086	-
100 mg SP2086	100 mg SP2086	-
200 mg SP2086	200 mg SP2086	-

Primary Outcome Measures

Name	Time	Method
the change from baseline in HbA1c at 12 week	baseline, week 12

Secondary Outcome Measures

Name	Time	Method
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12	baseline, week 4 ,12
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 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
Change From Baseline in Body Weight at Week 4,8,12	baseline, Week 4, 8,12

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China