A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes
NCT ID: NCT01969357
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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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2011-06-30
2012-06-30
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
Tablets(n=4),once daily for 84 days
50 mg SP2086
50 mg SP2086
Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
100 mg SP2086
100 mg SP2086
Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
200 mg SP2086
200 mg SP2086
Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
100 mg Sitagliptin
100 mg Sitagliptin
Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
70 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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Other Identifiers
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HR-SP-201
Identifier Type: -
Identifier Source: org_study_id