Type 2 DiabetesPhase 2NCT01984489
Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes
A Phase 2 study testing SHR117887 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control 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?
- SHR117887
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2013
- 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
- Patients diagnosed with type 2 diabetes mellitus
- Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
- HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
- Age:≥20 and ≤70 years
- BMI(body mass index):≥20 and ≤35 kg/m2
Who cannot join
- -
About this study
Official title: A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SHR117887 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients
SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo, SHR117887
- Keywords
- SHR117887, Metformin,combination,PhaseII
- 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
SHR117887Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Metformin | Placebo comparator | patients are administered oral tablets of placebo once daily and 500mg TID for 4 weeks at the run-in period. After randomized ,patients administer the drugs too. Receives: Drug: Placebo |
| SHR117887 (50mg q.d)/Metformin | Experimental | patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 50mg QD and metformin 500mg TID for 12 weeks. Receives: Drug: SHR117887 |
| SHR117887 (100mg q.d)/Metformin | Experimental | patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 100mg QD and metformin 500mg TID for 12 weeks. Receives: Drug: SHR117887 |
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 Week 12
Measured: 12 weeks
Secondary outcomes (4)
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Measured: 12 weeks
Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12
Measured: 12 weeks
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12
Measured: 12 weeks
Change From Baseline in Body Weight at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionAug 2013
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984489
- Sponsor's protocol ID
- SHR117887-201
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 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 II Study to Access the Efficacy and Safety of SHR117887 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT01984489
- Acronym / sponsor ID
- SHR117887-201
- Conditions
- Type 2 Diabetes
- Keywords
- SHR117887, Metformin,combination,PhaseII
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Nov 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.
SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes 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: Placebopatients are administered oral tablets of placebo once daily and 500mg TID for 4 weeks at the run-in period. After randomized ,patients administer the drugs too. |
| SHR117887 (50mg q.d)/Metformin | Experimental | Drug: SHR117887patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 50mg QD and metformin 500mg TID for 12 weeks. |
| SHR117887 (100mg q.d)/Metformin | Experimental | Drug: SHR117887patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 100mg QD and metformin 500mg TID for 12 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with type 2 diabetes mellitus
- Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
- HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
- Age:≥20 and ≤70 years
- BMI(body mass index):≥20 and ≤35 kg/m2
Key exclusion criteria (1 listed)
- -
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 | Drug | Placebo/Metformin |
| SHR117887 | Drug | SHR117887 (100mg q.d)/Metformin, SHR117887 (50mg q.d)/Metformin |
Primary outcome
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
Time frame: 12 weeks
4 secondary outcomes
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Time frame: 12 weeks
Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12
Time frame: 12 weeks
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12
Time frame: 12 weeks
Change From Baseline in Body Weight at Week 12
Time frame: 12 weeks
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 19 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR117887 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
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 5 inclusion and 1 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12 (time frame: 12 weeks). 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 19 Nov 2013.