Type 2 DiabetesPhase 2NCT01969357
A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes
A Phase 2 study testing 50 mg SP2086, 100 mg SP2086 and 200 mg SP2086 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- 50 mg SP2086, 100 mg SP2086 and 200 mg SP2086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized, Double-blind, Placebo and Positive Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo, 50 mg SP2086, 100 mg SP2086, 200 mg SP2086, 100 mg Sitagliptin
- Keywords
- Sp2086, Phase II, monotherapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablets(n=4),once daily for 84 days
50 mg SP2086Drug
Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
100 mg SP2086Drug
Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
200 mg SP2086Drug
Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
100 mg SitagliptinDrug
Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 50 mg SP2086 | Experimental | Not described Receives: Drug: 50 mg SP2086 |
| 100 mg SP2086 | Experimental | Not described Receives: Drug: 100 mg SP2086 |
| 200 mg SP2086 | Experimental | Not described Receives: Drug: 200 mg SP2086 |
| 100 mg Sitagliptin | Active comparator | Not described Receives: Drug: 100 mg Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline in HbA1c at 12 week
Measured: baseline, week 12
Secondary outcomes (6)
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Measured: week 12
Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12
Measured: Baseline, Week 4, 8, 12
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12
Measured: baseline, week 4 ,12
Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12
Measured: baseline, week 4,12week
Change From Baseline in lipid at Week 4, 8 and 12
Measured: baseline, week 4, 8, 12
Change From Baseline in Body Weight at Week 4,8,12
Measured: baseline, Week 4, 8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changyu Pan, M.D., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969357
- Sponsor's protocol ID
- HR-SP-201
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Double-blind, Placebo and Positive Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT01969357
- Acronym / sponsor ID
- HR-SP-201
- Conditions
- Type 2 Diabetes
- Keywords
- Sp2086, Phase II, monotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTablets(n=4),once daily for 84 days | Drug | Placebo |
| 50 mg SP2086Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days | Drug | 50 mg SP2086 |
| 100 mg SP2086Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days | Drug | 100 mg SP2086 |
| 200 mg SP2086Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days | Drug | 200 mg SP2086 |
| 100 mg SitagliptinTablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days | Drug | 100 mg Sitagliptin |
Primary outcome
the change from baseline in HbA1c at 12 week
Time frame: baseline, week 12
6 secondary outcomes
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Time frame: week 12
Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12
Time frame: Baseline, Week 4, 8, 12
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12
Time frame: baseline, week 4 ,12
Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12
Time frame: baseline, week 4,12week
Change From Baseline in lipid at Week 4, 8 and 12
Time frame: baseline, week 4, 8, 12
Change From Baseline in Body Weight at Week 4,8,12
Time frame: baseline, Week 4, 8,12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changyu Pan, M.D. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 mg SP2086, 100 mg SP2086 and 200 mg SP2086 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline in HbA1c at 12 week (time frame: baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.