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Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02222350
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Description
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Brief Summary:
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: 10mg DS-8500a tablet Drug: 75mg DS-8500a tablet Drug: placebo Phase 2

Detailed Description:
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes
Study Start Date : July 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DS-8500a 10mg once daily
10mg DS-8500a tablet given orally once daily
 Drug: 10mg DS-8500a tablet
Experimental: DS8500a 75 mg once daily
75mg DS-8500a tablet given orally once daily
 Drug: 75mg DS-8500a tablet
Placebo Comparator: placebo to match DS-8500a tablet
placebo matching DS-8500a tablet
 Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. change in 24-hour weighted mean blood glucose [ Time Frame: Day -1 (baseline) to Day 28 ]

Secondary Outcome Measures :
  1. change in 24 hour weighted mean blood glucose [ Time Frame: Day -1 (baseline) to Day 14 ]
  2. change in blood fasting plasma glucose level [ Time Frame: Day -1 (baseline) to Days 7, 14, 21, 28 ]
  3. change in blood plasma glucose level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  4. change in blood insulin level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  5. change in blood C-peptide level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  6. change in blood active GLP-1 level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  7. change in blood PYY level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  8. change in blood HbA1c level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  9. change in blood glycoalbumin level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in the parameter at Day 14 or 28 from Day -1

  10. Number of subjects experiencing adverse events as a measure of safety [ Time Frame: Day -1 (baseline) to Day 28 ]
    Number of subjects experiencing adverse events

  11. pharmacokinetic profile of DS-8500a [ Time Frame: Day -1 (baseline) to Day 28 ]
    Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2

  12. change in postprandial plasma glucose level [ Time Frame: Day -1 (baseline) to Days 14 and 28 ]
    Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥ 20 years at the time of informed consent
  • Japanese patients with type 2 diabetes
  • Patients who have HbA1c ≥ 7.0% and < 10.0% if untreated with antidiabetic agent.
  • Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent.

Exclusion Criteria:

  • Patients aged ≥ 70 years at the time of informed consent
  • Patients with a history of type 1 diabetes or diabetic ketoacidosis
  • Patients receiving or requiring treatment with insulin
  • Patients with a body mass index (BMI) of < 18.5 kg/m2 or ≥ 35.0 kg/m2
  • Patients with an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2
  • Patients with fasting plasma glucose ≥ 240 mg/dL
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222350


Locations
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Japan
Heishinkai Medical Group Incorporated OCROM Clinic
Kasuga, Osaka, Japan, 565-0853
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02222350    
Other Study ID Numbers: DS8500-A-J201
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Firuglipel
Hypoglycemic Agents
Physiological Effects of Drugs