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Completed

NCT Number: NCT02222350

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heishinkai Medical Group Incorporated OCROM Clinic

Kasuga, Osaka, 565-0853, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10mg DS-8500a tablet

Drug

75mg DS-8500a tablet

Drug

Placebo

Drug

Primary outcomes

  1. change in 24-hour weighted mean blood glucose

    Time frame: Day -1 (baseline) to Day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 21, 2014
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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