A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase III Study to Access the Efficacy and Safety of SP2086 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country360 target enrollmentApril 2013

ConditionsType 2 Diabetes

InterventionsPlacebo/Metformin SP2086 50 mg b.i.d/Metformin SP2086 50 mg q.d./Metformin

DrugsPlacebo/Metformin SP2086 50 mg b.i.d/Metformin SP2086 50 mg q.d./Metformin

Overview

Phase: Phase 3
Intervention: Placebo/Metformin
Conditions: Type 2 Diabetes
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 360
Locations: 1
Primary Endpoint: Change From Baseline in HbA1c (Hemoglobin A1C) at Week24
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

January 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with type 2 diabetes mellitus
•subject on metformin monotherapy with stable dose ≥1500mg/d for ≥8 weeks
•7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in
•Body Mass Index: ≥19 and ≤35 kg/m2

Exclusion Criteria

•\<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
•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

Arms & Interventions

Placebo/Metformin

Intervention: Placebo/Metformin

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

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

SP2086 (50mg q.d.)/Metformin

Intervention: SP2086 50 mg q.d./Metformin

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Hemoglobin A1C) at Week24

Time Frame: baseline, week 24

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

Secondary Outcomes

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)
Change From Baseline in Body Weight at Week 4,8,12、24、38、52(Week 4、8、12、24、38、52)