Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes

NCT01969318 | Completed Phase 2

• 1 other identifier: 2086-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

SP2086; Phase II; combination therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12

  baseline, week 12

Secondary Outcomes (6)

• 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

• Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12

  baseline, week 12

• Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week12

  baseline, week 12

• Change From Baseline in lipid at Week 12

  baseline, week12

Study Arms (3)

Placebo/Metformin

PLACEBO COMPARATOR

Drug: Placebo /Metformin

SP2086 (50mg q.d)/Metformin

EXPERIMENTAL

Drug: SP2086(50 mg q.d.)/Metformin

SP2086 (100mg q.d.)/Metformin

EXPERIMENTAL

Drug: SP2086 (100 mg q.d.)/Metformin

Interventions

Placebo /Metformin DRUG

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

Placebo/Metformin

SP2086(50 mg q.d.)/Metformin DRUG

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

SP2086 (50mg q.d)/Metformin

SP2086 (100 mg q.d.)/Metformin DRUG

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

SP2086 (100mg q.d.)/Metformin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<80% or \>120% compliance with placebo treatment during the run-in period
• Patients used the following drugs or therapies prior to randomization:
• \) 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:
• Type 1 diabetes, single gene mutation diabetes, diabetes caused by pancreatic damage and secondary diabetes, such as caused by Cushing's syndrome or acromegaly
• a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
• a history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
• serious haematological diseases or other diseases leading to hemolyze and Red Blood Cell unstable (malaria、haemolytic anaemia eg. )
• other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
• 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
• 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
• Acute metabolic complications (ketoacidosis, lactic acidosis or hyperosmolar coma), unstable proliferative retinopathy or macular degeneration within 6 months prior to randomization
• Severe trauma or acute infection that may affect blood glucose control within 4 weeks prior to randomization
• Severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
• With a history of mental/emotional disorder that would interfere with the subject's participation in the study.
• \. Patients with any laboratory parameters meet the following criteria prior to randomization:

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Changyu Pan, M.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 25, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

CN (1)