Type 2 DiabetesPhase 3NCT01970046
A Phase III Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes
A Phase 3 study testing SP2086 50 mg b.i.d/Metformin and SP2086 50 mg q.d./Metformin 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 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SP2086 50 mg b.i.d/Metformin and SP2086 50 mg q.d./Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <80% or >120% compliance with placebo treatment during the run-in period
- Patients used the following drugs or therapies prior to randomization:
- 1) 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 4. 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
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- 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
- Decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical significance arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention within 6 months prior to randomization
- Acute metabolic complications (ketoacidosis, lactic acidosis or hyperosmolar coma), unstable proliferative retinopathy or macular degeneration within 6 months prior to randomization
- Severe trauma or acute infection that may affect blood glucose control within 4 weeks prior to randomization
- Severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
- With a history of mental/emotional disorder that would interfere with the subject's participation in the study.
- 5. Patients with any laboratory parameters meet the following criteria prior to randomization:
- Aspartate Aminotransferase or alanine aminotransferase ≥ 2.0× upper normal limit(UNL) , and/or total bilirubin ≥ 2.0 × UNL also review confirmed within 3 days;
- Triglyceride>5.64mmol/L（500mg/dl）；
- serum creatinine to exceed the normal range
- thyroid stimulating hormone to exceed the normal range, and have clinical significance
- blood amylase o exceed the normal range, and have clinical significance
- In investigator's opinion, any significant laboratory abnormalities of clinical significance value that interfere with assessment of this study.
- 6. At Screening patients not installed pacemaker with II or III degree atrioventricular block, long QT syndrome or QT corrected > 500 ms 7. Patients who received blood transfusions or blood donation≥ 400 mL or severe blood loss at least 400 mL within 8 weeks prior to randomization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Changyu Pan, M.D., panchy301@aliyun.com
Changyu Pan, M.D.
About this study
Official title: 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
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
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo/Metformin, SP2086 50 mg b.i.d/Metformin, SP2086 50 mg q.d./Metformin
- Keywords
- SP2086, Phase III, combination therapy
- 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.
Placebo/MetforminDrug
- Run in period ：placebo and metformin 500 mg t.i.d for 6 weeks
- Phase A : Placebo and metformin 500 mg t.i.d for 24 weeks
- Phase B : SP2086 50 mg b.i.d and metformin 500 mg t.i.d for 28 weeks
SP2086 50 mg b.i.d/MetforminDrug
- Run-in period: placebo and Metformin 500 mg t.i.d for 6weeks
- Phase A:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 24 weeks
- Phase B:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 28 weeks
SP2086 50 mg q.d./MetforminDrug
- Run-in period: placebo and Metformin 500 mg t.i.d for 6 weeks
- Phase A:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 24 weeks
- Phase B:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 28 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Metformin | Placebo comparator | Not described Receives: Drug: Placebo/Metformin |
| SP2086 (50mg b.i.d)/Metformin | Experimental | Not described Receives: Drug: SP2086 50 mg b.i.d/Metformin |
| SP2086 (50mg q.d.)/Metformin | Experimental | Not described Receives: Drug: SP2086 50 mg q.d./Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, week 24
Secondary outcomes (6)
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Measured: week24, 52
Change From Baseline in fasting plasma glucose (FPG) at Week 24,52
Change from baseline at Week 24,52 is defined as Week 24 ,52 FPG minus Week 0 FPG
Measured: Weeks 0-24-52
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
Measured: Weeks 0-24
Change From Baseline in HbA1c at Week 52
A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent
Measured: week 52
Change From Baseline in lipid at Week 4、8、12、24、38、52
Measured: Week 4、8、12、24、38、52
Change From Baseline in Body Weight at Week 4,8,12、24、38、52
Measured: Week 4、8、12、24、38、52
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 startApr 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
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
- NCT01970046
- Sponsor's protocol ID
- HR-SP2086-302
- Status last verified
- Oct 2013
- First submitted
- 18 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 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
- ClinicalTrials.gov ID
- NCT01970046
- Acronym / sponsor ID
- HR-SP2086-302
- Conditions
- Type 2 Diabetes
- Keywords
- SP2086, Phase III, combination therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo/Metformin | Placebo comparator | Drug: Placebo/Metformin |
| SP2086 (50mg b.i.d)/Metformin | Experimental | Drug: SP2086 50 mg b.i.d/Metformin |
| SP2086 (50mg q.d.)/Metformin | Experimental | Drug: SP2086 50 mg q.d./Metformin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- <80% or >120% compliance with placebo treatment during the run-in period
- Patients used the following drugs or therapies prior to randomization:
- 1) 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 4. 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
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 |
|---|---|---|
| Placebo/Metformin* Run in period ：placebo and metformin 500 mg t.i.d for 6 weeks * Phase A : Placebo and metformin 500 mg t.i.d for 24 weeks * Phase B : SP2086 50 mg b.i.d and metformin 500 mg t.i.d for 28 weeks | Drug | Placebo/Metformin |
| SP2086 50 mg b.i.d/Metformin* Run-in period: placebo and Metformin 500 mg t.i.d for 6weeks * Phase A:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 24 weeks * Phase B:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 28 weeks | Drug | SP2086 (50mg b.i.d)/Metformin |
| SP2086 50 mg q.d./Metformin* Run-in period: placebo and Metformin 500 mg t.i.d for 6 weeks * Phase A:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 24 weeks * Phase B:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 28 weeks | Drug | SP2086 (50mg q.d.)/Metformin |
Primary outcome
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
6 secondary outcomes
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Time frame: week24, 52
Change From Baseline in fasting plasma glucose (FPG) at Week 24,52
Time frame: Weeks 0-24-52
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
Time frame: Weeks 0-24
Change From Baseline in HbA1c at Week 52
Time frame: week 52
Change From Baseline in lipid at Week 4、8、12、24、38、52
Time frame: Week 4、8、12、24、38、52
Change From Baseline in Body Weight at Week 4,8,12、24、38、52
Time frame: Week 4、8、12、24、38、52
Results and safety
Results are not available in the source record.
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 3 study testing SP2086 50 mg b.i.d/Metformin and SP2086 50 mg q.d./Metformin 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 4 inclusion and 22 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: status not confirmed, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changyu Pan, M.D. (86 10 66887329, panchy301@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c (Hemoglobin A1C) at Week24 (time frame: baseline, week 24). 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.