NCT01969357

Brief Summary

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

10 months

First QC Date

October 17, 2013

Last Update Submit

October 21, 2013

Conditions

Type 2 Diabetes

Keywords

Sp2086Phase IImonotherapy

Outcome Measures

Primary Outcomes (1)

  • the change from baseline in HbA1c at 12 week

    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 4 ,12

    baseline, week 4 ,12

  • Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12

    baseline, week 4,12week

  • Change From Baseline in lipid at Week 4, 8 and 12

    baseline, week 4, 8, 12

  • +1 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

50 mg SP2086

EXPERIMENTAL
Drug: 50 mg SP2086

100 mg SP2086

EXPERIMENTAL
Drug: 100 mg SP2086

200 mg SP2086

EXPERIMENTAL
Drug: 200 mg SP2086

100 mg Sitagliptin

ACTIVE COMPARATOR
Drug: 100 mg Sitagliptin

Interventions

PlaceboDRUG

Tablets(n=4),once daily for 84 days

Placebo
50 mg SP2086DRUG

Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days

50 mg SP2086
100 mg SP2086DRUG

Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days

100 mg SP2086
200 mg SP2086DRUG

Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days

200 mg SP2086
100 mg SitagliptinDRUG

Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days

100 mg Sitagliptin

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus
  • Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5%
  • BMI 19\~35 kg/m2

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 25, 2013

Study Start

June 1, 2011

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

CN(1)