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

Overview[ - collapse ][ - ]

Purpose 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
ConditionType 2 Diabetes
InterventionDrug: Placebo /Metformin
Drug: SP2086(50 mg q.d.)/Metformin
Drug: SP2086 (100 mg q.d.)/Metformin
PhasePhase 2
SponsorJiangsu HengRui Medicine Co., Ltd.
Responsible PartyJiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov IdentifierNCT01969318
First ReceivedOctober 17, 2013
Last UpdatedOctober 21, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 17, 2013
Last Updated DateOctober 21, 2013
Start DateMarch 2012
Estimated Primary Completion DateNovember 2012
Current Primary Outcome MeasuresChange From Baseline in HbA1c (Hemoglobin A1C) at Week 12 [Time Frame: baseline, week 12] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels [Time Frame: week 12] [Designated as safety issue: No]
  • Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12 [Time Frame: Baseline, Week 4, 8, 12] [Designated as safety issue: No]
  • Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12 [Time Frame: baseline, week 12] [Designated as safety issue: No]
  • Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week12 [Time Frame: baseline, week 12] [Designated as safety issue: No]
  • Change From Baseline in lipid at Week 12 [Time Frame: baseline, week12] [Designated as safety issue: No]
  • Change From Baseline in Body Weight at Week 4,8,12 [Time Frame: baseline, Week 4, 8,12] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes
Official TitleA 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
Brief 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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
ConditionType 2 Diabetes
InterventionDrug: Placebo /Metformin
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
Drug: SP2086(50 mg q.d.)/Metformin
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
Drug: SP2086 (100 mg q.d.)/Metformin
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 Arm (s)
  • Placebo Comparator: Placebo/Metformin
  • Experimental: SP2086 (50mg q.d)/Metformin
  • Experimental: SP2086 (100mg q.d.)/Metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment120
Estimated Completion DateNovember 2012
Estimated Primary Completion DateAugust 2012
Eligibility Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

1. <80% or >120% compliance with placebo treatment during the run-in period

2. 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:

1. Type 1 diabetes, single gene mutation diabetes, diabetes caused by pancreatic damage
and secondary diabetes, such as caused by Cushing's syndrome or acromegaly

2. a history of hypertension, and after antihypertensive treatment, systolic blood
pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg

3. a history of acute and chronic pancreatitis or pancreatic injury that may lead to
high risk of pancreatitis

4. serious haematological diseases or other diseases leading to hemolyze and Red Blood
Cell unstable (malaria、haemolytic anaemia eg. )

5. other endocrine diseases, for example
hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so
on

6. 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

7. 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

8. Acute metabolic complications (ketoacidosis, lactic acidosis or hyperosmolar coma),
unstable proliferative retinopathy or macular degeneration within 6 months prior to
randomization

9. Severe trauma or acute infection that may affect blood glucose control within 4 weeks
prior to randomization

10. Severe chronic gastrointestinal disease or therapy that may affect drug absorption,
such as gastrointestinal surgery

11. 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:

1. Aspartate Aminotransferase or alanine aminotransferase ≥ 2.0× upper normal
limit(UNL) , and/or total bilirubin ≥ 2.0 × UNL also review confirmed within 3 days;

2. Triglyceride>5.64mmol/L(500mg/dl);

3. serum creatinine to exceed the normal range

4. thyroid stimulating hormone to exceed the normal range, and have clinical
significance

5. blood amylase o exceed the normal range, and have clinical significance

6. 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

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GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT01969318
Other Study ID Numbers2086-202
Has Data Monitoring CommitteeNo
Information Provided ByJiangsu HengRui Medicine Co., Ltd.
Study SponsorJiangsu HengRui Medicine Co., Ltd.
CollaboratorsNot Provided
Investigators Principal Investigator: Changyu Pan, M.D. Chinese PLA General Hospital
Verification DateOctober 2013

Locations[ + expand ][ + ]

Chinese PLA General Hospital
Beijing, China