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Type 2 DiabetesPhase 2NCT01969318

Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes

A Phase 2 study testing SP2086(50 mg q.d.)/Metformin and SP2086 (100 mg q.d.)/Metformin in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SP2086 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?
SP2086(50 mg q.d.)/Metformin and SP2086 (100 mg q.d.)/Metformin
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
1 siteChina
Study dates
Mar 2012to Nov 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

  • Patients diagnosed with type 2 diabetes mellitus
  • subject on metformin nontherapy with dose 1500mg/d for ≥12 weeks
  • HbA1C：≥7.5% and ≤11.0%
  • BMI:≥20 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
Show all 23Show fewer
  • 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

  • Chinese PLA General Hospital

    Beijing

Other trials in China

About this study

Official title: A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II 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 dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SP2086 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 /Metformin, SP2086(50 mg q.d.)/Metformin, SP2086 (100 mg q.d.)/Metformin
Keywords
SP2086, Phase II, 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

    Patients are administered oral tablets of placebo once daily and metformin 500 mg t.i.d for 2 weeks at run-in period.After randomized,patients will be administered the drugs too

  • SP2086(50 mg q.d.)/MetforminDrug

    patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 50 mg q.d. and 500 mg t.i.d for 12 weeks

  • SP2086 (100 mg q.d.)/MetforminDrug

    patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 100 mg q.d. and 500 mg t.i.d for 12 weeks

Study groups in NCT01969318
Study groupRoleWhat they receive
Placebo/MetforminPlacebo comparatorNot described
Receives: Drug: Placebo /Metformin
SP2086 (50mg q.d)/MetforminExperimentalNot described
Receives: Drug: SP2086(50 mg q.d.)/Metformin
SP2086 (100mg q.d.)/MetforminExperimentalNot described
Receives: Drug: SP2086 (100 mg q.d.)/Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12

    Measured: baseline, week 12

Secondary outcomes (6)

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

    Measured: week 12

  2. Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12

    Measured: Baseline, Week 4, 8, 12

  3. Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12

    Measured: baseline, week 12

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

    Measured: baseline, week 12

  5. Change From Baseline in lipid at Week 12

    Measured: baseline, week12

  6. 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.

  1. First posted25 Oct 2013 (estimated)
  2. Study startMar 2012
  3. Primary completionAug 2012
  4. Study completionNov 2012

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969318
Sponsor's protocol ID
2086-202
Status last verified
Oct 2013
First submitted
17 Oct 2013
Last updated
25 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SP2086(50 mg q.d.)/Metformin and SP2086 (100 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 23 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?

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12 (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?

On the ClinicalTrials.gov record for NCT01969318.

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.

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