A Phase III Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes

NCT01970046 | Unknown Phase 3

• 1 other identifier: HR-SP2086-302
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control

Conditions

Type 2 Diabetes

Keywords

SP2086; Phase III; combination therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Hemoglobin A1C) at Week24

  A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent

  baseline, week 24

Secondary Outcomes (6)

• Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels

  week24, 52

• Change From Baseline in fasting plasma glucose (FPG) at Week 24,52

  Weeks 0-24-52

• Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24

  Weeks 0-24

• Change From Baseline in HbA1c at Week 52

  week 52

• Change From Baseline in lipid at Week 4、8、12、24、38、52

  Week 4、8、12、24、38、52

Study Arms (3)

Placebo/Metformin

PLACEBO COMPARATOR

Drug: Placebo/Metformin

SP2086 (50mg b.i.d)/Metformin

EXPERIMENTAL

Drug: SP2086 50 mg b.i.d/Metformin

SP2086 (50mg q.d.)/Metformin

EXPERIMENTAL

Drug: SP2086 50 mg q.d./Metformin

Interventions

Placebo/Metformin DRUG

* Run in period ：placebo and metformin 500 mg t.i.d for 6 weeks * Phase A : Placebo and metformin 500 mg t.i.d for 24 weeks * Phase B : SP2086 50 mg b.i.d and metformin 500 mg t.i.d for 28 weeks

Placebo/Metformin

SP2086 50 mg b.i.d/Metformin DRUG

* Run-in period: placebo and Metformin 500 mg t.i.d for 6weeks * Phase A:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 24 weeks * Phase B:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 28 weeks

SP2086 (50mg b.i.d)/Metformin

SP2086 50 mg q.d./Metformin DRUG

* Run-in period: placebo and Metformin 500 mg t.i.d for 6 weeks * Phase A:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 24 weeks * Phase B:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 28 weeks

SP2086 (50mg q.d.)/Metformin

Eligibility Criteria

• Age: 18 Years - 80 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 monotherapy with stable dose ≥1500mg/d for ≥8 weeks
• % ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in
• Body Mass Index: ≥19 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

RECRUITING

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

Central Study Contacts

Changyu Pan, M.D.

CONTACT

86 10 66887329; panchy301@aliyun.com

Huaqiong Shen, P.H.D

CONTACT

86 21 68868570; shenhuaqiong@hrs.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 25, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

CN (1)