NCT01970033

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes

Timeline
Completed

Started Dec 2012

Typical duration for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

October 18, 2013

Last Update Submit

October 22, 2013

Conditions

Type 2 Diabetes

Keywords

SP2086Phase IIIMonotherapy

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 (7)

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

    Weeks 0-24

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

    Weeks 0-24

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

    week24

  • Change From Baseline in A1C at Week 52

    week 52

  • Change From Baseline in FPG at Week 52

    week 52

  • +2 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

SP2086 50 mg b.i.d

EXPERIMENTAL
Drug: SP2086 50 mg b.i.d.

SP2086 100 mg q.d.

EXPERIMENTAL
Drug: SP2086 100 mg q.d.

Interventions

PlaceboDRUG

* 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

Placebo
SP2086 50 mg b.i.d.DRUG

* 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

SP2086 50 mg b.i.d
SP2086 100 mg q.d.DRUG

* 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

SP2086 100 mg q.d.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Changyu Pan, M.D.

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changyu Pan, M.D.

CONTACT

86 10 66887329panchy301@aliyun.com

Huaqiong Shen, P.H.D

CONTACT

86 21 68868570shenhuaqiong@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

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

CN(1)