Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes
NCT ID: NCT01970033
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
450 participants
INTERVENTIONAL
2012-12-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
* Run in period ：oral tablets of Placebo twice daily for 2 weeks
* Phase A : oral tablets of Placebo twice daily for 24 weeks
* Phase B : SP2086 50 mg b.i.d or SP2086 100 mg q.d. for 28 weeks
SP2086 50 mg b.i.d
SP2086 50 mg b.i.d.
* Run-in period: placebo twice daily for 2 weeks
* Phase A:SP2086 50 mg b.i.d for 24 weeks
* Phase B:SP2086 50 mg b.i.d for 28 weeks
SP2086 100 mg q.d.
SP2086 100 mg q.d.
* Run-in period:placebo twice daily for 2 weeks
* Phase A: SP2086 100 mg q.d. for 24 weeks
* Phase B: SP2086 100 mg q.d. for 28 weeks
Interventions
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Placebo
* Run in period ：oral tablets of Placebo twice daily for 2 weeks
* Phase A : oral tablets of Placebo twice daily for 24 weeks
* Phase B : SP2086 50 mg b.i.d or SP2086 100 mg q.d. for 28 weeks
SP2086 50 mg b.i.d.
* Run-in period: placebo twice daily for 2 weeks
* Phase A:SP2086 50 mg b.i.d for 24 weeks
* Phase B:SP2086 50 mg b.i.d for 28 weeks
SP2086 100 mg q.d.
* Run-in period:placebo twice daily for 2 weeks
* Phase A: SP2086 100 mg q.d. for 24 weeks
* Phase B: SP2086 100 mg q.d. for 28 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Changyu Pan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Changyu Pan, M.D.
Role: primary
Other Identifiers
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HR-SP2086-301
Identifier Type: -
Identifier Source: org_study_id