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Status unknownNCT01970033Updated Oct 25, 2013

Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes

A Phase 3 interventional study of Placebo and SP2086 50 mg b.i.d. in Type 2 Diabetes, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-10-25.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • SP2086
  • Phase III
  • Monotherapy
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 450 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 570 studies on the registry; 85 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with type 2 diabetes mellitus
  • Patients have treated with diet/exercise at least 3 months
  • 7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in

Exclusion criteria

Exclusion Criteria:

  • Patient has history of type 1 diabetes mellitus
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    SP2086 50 mg b.i.d

    Drug: SP2086 50 mg b.i.d.

  • Experimental
    SP2086 100 mg q.d.

    Drug: SP2086 100 mg q.d.

Interventions

  • DrugPlacebo

    * Run in period ：oral tablets of Placebo twice daily for 2 weeks * Phase A : oral tablets of Placebo twice daily for 24 weeks * Phase B : SP2086 50 mg b.i.d or SP2086 100 mg q.d. for 28 weeks

  • DrugSP2086 50 mg b.i.d.

    * Run-in period: placebo twice daily for 2 weeks * Phase A:SP2086 50 mg b.i.d for 24 weeks * Phase B:SP2086 50 mg b.i.d for 28 weeks

  • DrugSP2086 100 mg q.d.

    * Run-in period:placebo twice daily for 2 weeks * Phase A: SP2086 100 mg q.d. for 24 weeks * Phase B: SP2086 100 mg q.d. for 28 weeks

06

What researchers measure

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

    Time frame: baseline, week 24

Secondary outcomes

  1. Change From Baseline in fasting plasma glucose (FPG) at Week 24

    Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG

    Time frame: Weeks 0-24

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

    Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG

    Time frame: Weeks 0-24

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

    Time frame: week24

  4. Change From Baseline in A1C at Week 52

    A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent

    Time frame: week 52

  5. Change From Baseline in FPG at Week 52

    Change from baseline at Week 52 is defined as Week 104 FPG minus Week 0 FPG

    Time frame: week 52

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

    Time frame: Week 4、8、12、24、38、52

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

    Time frame: Week 4、8、12、24、38、52

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01970033
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Oct 25, 2013
Start date
Dec 2012
Primary completion
Jan 2014 (estimated)
Completion
Jan 2015 (estimated)
Last update
Oct 25, 2013

Study contacts

Changyu Pan, M.D.
Contact
panchy301@aliyun.com
86 10 66887329
Huaqiong Shen, P.H.D
Contact
shenhuaqiong@hrs.com.cn
86 21 68868570 ext. 827
Changyu Pan, M.D.
principal investigator · Chinese PLA General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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