Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control |
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Condition | Type 2 Diabetes |
Intervention | Drug: Placebo /Metformin Drug: SP2086(50 mg q.d.)/Metformin Drug: SP2086 (100 mg q.d.)/Metformin |
Phase | Phase 2 |
Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
Responsible Party | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier | NCT01969318 |
First Received | October 17, 2013 |
Last Updated | October 21, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 17, 2013 |
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Last Updated Date | October 21, 2013 |
Start Date | March 2012 |
Estimated Primary Completion Date | November 2012 |
Current Primary Outcome Measures | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12 [Time Frame: baseline, week 12] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes |
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Official Title | A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients |
Brief Summary | SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
Condition | Type 2 Diabetes |
Intervention | Drug: Placebo /Metformin Patients are administered oral tablets of placebo once daily and metformin 500 mg t.i.d for 2 weeks at run-in period.After randomized,patients will be administered the drugs too Drug: SP2086(50 mg q.d.)/Metformin patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 50 mg q.d. and 500 mg t.i.d for 12 weeks Drug: SP2086 (100 mg q.d.)/Metformin patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 100 mg q.d. and 500 mg t.i.d for 12 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 120 |
Estimated Completion Date | November 2012 |
Estimated Primary Completion Date | August 2012 |
Eligibility Criteria | Inclusion Criteria: - Patients diagnosed with type 2 diabetes mellitus - subject on metformin nontherapy with dose 1500mg/d for ≥12 weeks - HbA1C:≥7.5% and ≤11.0% - BMI:≥20 and ≤35 kg/m2 Exclusion Criteria: 1. <80% or >120% compliance with placebo treatment during the run-in period 2. Patients used the following drugs or therapies prior to randomization: 1) Somatropin therapy within 6 months prior to randomization 2) History of drug or alcohol abuse within 6 months prior to randomization 3) Participate in clinical trials of any drugs or medical devices within 3 months prior to randomization 4) Receive corticosteroids long-term (more than 7 consecutive days) oral, non-gastrointestinal administration or intra-articular administration within 2 months prior to randomization 5) Weight control drugs administration or Surgeries resulting in weight instability within 2 months prior to randomization 6) In investigator's opinion, patients used any drugs that interfere with assessment of the investigational product, or produce vital organs toxicity 4. Patients with history of the following diseases or proof prior to randomization: 1. Type 1 diabetes, single gene mutation diabetes, diabetes caused by pancreatic damage and secondary diabetes, such as caused by Cushing's syndrome or acromegaly 2. a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg 3. a history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis 4. serious haematological diseases or other diseases leading to hemolyze and Red Blood Cell unstable (malaria、haemolytic anaemia eg. ) 5. other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on 6. Any organ system tumors except the local skin basal cell carcinoma that have been treated or not been treated within 5 years prior to randomization, regardless of whether there is evidence of local recurrence or metastasis ; a history or family history of medullary carcinoma of thyroid ; a history of multiple endocrine neoplasia 7. Decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical significance arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention within 6 months prior to randomization 8. Acute metabolic complications (ketoacidosis, lactic acidosis or hyperosmolar coma), unstable proliferative retinopathy or macular degeneration within 6 months prior to randomization 9. Severe trauma or acute infection that may affect blood glucose control within 4 weeks prior to randomization 10. Severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery 11. With a history of mental/emotional disorder that would interfere with the subject's participation in the study. 5. Patients with any laboratory parameters meet the following criteria prior to randomization: 1. Aspartate Aminotransferase or alanine aminotransferase ≥ 2.0× upper normal limit(UNL) , and/or total bilirubin ≥ 2.0 × UNL also review confirmed within 3 days; 2. Triglyceride>5.64mmol/L(500mg/dl); 3. serum creatinine to exceed the normal range 4. thyroid stimulating hormone to exceed the normal range, and have clinical significance 5. blood amylase o exceed the normal range, and have clinical significance 6. In investigator's opinion, any significant laboratory abnormalities of clinical significance value that interfere with assessment of this study. 6. At Screening patients not installed pacemaker with II or III degree atrioventricular block, long QT syndrome or QT corrected > 500 ms 7. Patients who received blood transfusions or blood donation≥ 400 mL or severe blood loss at least 400 mL within 8 weeks prior to randomization - |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01969318 |
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Other Study ID Numbers | 2086-202 |
Has Data Monitoring Committee | No |
Information Provided By | Jiangsu HengRui Medicine Co., Ltd. |
Study Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
Collaborators | Not Provided |
Investigators | Principal Investigator: Changyu Pan, M.D. Chinese PLA General Hospital |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
Chinese PLA General Hospital | Beijing, China |
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