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Completed

NCT Number: NCT02628392

A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.

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Key information

Conditions

Type2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heishinkai Medical Group Incorporated OCROM Clinic

Suita-shi, Osaka, Japan

About this study

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

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%

Exclusion criteria

  • Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or 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 clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease
  • Patients with fasting plasma glucose ≥ 240 mg/dL

Treatment and study plan

DS-8500a

Drug

DS-8500a tablets 25mg, 50mg, 75mg

Sitagliptin

Drug

capsules

Other names: Januvia

Placebo

Drug

matching DS-8500a tablets and sitagliptin capsules

Primary outcomes

  1. change in HbA1c

    Time frame: baseline (Day -1) to Week 12

    HbA1c = glycated hemoglobin

Secondary outcomes

  1. change in HbA1c

    Time frame: baseline (Day -1) to Week 4

  2. change in HbA1c

    Time frame: baseline (Day -1) to Week 8

  3. proportion of subjects with HbA1c <7.0

    Time frame: baseline (Day -1) to Week 12

    proportion of subjects who achieve HbA1c <7.0

  4. change in plasma glucose

    Time frame: baseline (Day -1) to Week 4

  5. change in plasma glucose

    Time frame: baseline (Day -1) to Week 12

  6. change in AUC derived from plasma glucose

    Time frame: baseline (Day -1) to Week 4

    change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)

  7. change in AUC derived from plasma glucose

    Time frame: baseline (Day -1) to Week 12

    pharmacodynamics profile consists of AUC, Cmax, Tmax

  8. change in serum insulin

    Time frame: baseline (Day -1) to Week 4

  9. change in AUC 0-3h serum insulin

    Time frame: baseline (Day -1) to Week 4

  10. change in serum insulin

    Time frame: baseline (Day -1) to Week 12

  11. change in AUC 0-3h serum insulin

    Time frame: baseline (Day -1) to Week 12

  12. change in proinsulin

    Time frame: baseline (Day -1) to Week 4

  13. change in AUC 0-3h proinsulin

    Time frame: baseline (Day -1) to Week 4

  14. change in proinsulin

    Time frame: baseline (Day -1) to Week 12

  15. change in AUC 0-3h proinsulin

    Time frame: baseline (Day -1) to Week 12

  16. change in C-peptide

    Time frame: baseline (Day -1) to Week 4

  17. change in AUC 0-3h C-peptide

    Time frame: baseline (Day -1) to Week 4

  18. change in C-peptide

    Time frame: baseline (Day -1) to Week 12

  19. change in AUC 0-3h C-peptide

    Time frame: baseline (Day -1) to Week 12

  20. change in PYY

    Time frame: baseline (Day -1) to Week 4

    PYY = peptide YY

  21. change in AUC 0-3h PYY

    Time frame: baseline (Day -1) to Week 4

  22. change in PYY

    Time frame: baseline (Day -1) to Week 12

  23. change in AUC 0-3h PYY

    Time frame: baseline (Day -1) to Week 12

  24. change in total GLP-1

    Time frame: baseline (Day -1) to Week 4

    GLP-1 = Glucagon-Like Peptide-1

  25. change in total AUC 0-3h GLP-1

    Time frame: baseline (Day -1) to Week 4

  26. change in total GLP-1

    Time frame: baseline (Day -1) to Week 12

  27. change in AUC 0-3h total GLP-1

    Time frame: baseline (Day -1) to Week 12

  28. change in active GLP-1

    Time frame: baseline (Day -1) to Week 4

  29. change in AUC 0-3h active GLP-1

    Time frame: baseline (Day -1) to Week 4

  30. change in active GLP-1

    Time frame: baseline (Day -1) to Week 12

  31. change in AUC 0-3h active GLP-1

    Time frame: baseline (Day -1) to Week 12

  32. change in total GIP

    Time frame: baseline (Day -1) to Week 4

    GIP = Gastric Inhibitory Polypeptide

  33. change in AUC 0-3h total GIP

    Time frame: baseline (Day -1) to Week 4

  34. change in total GIP

    Time frame: baseline (Day -1) to Week 12

  35. change in AUC 0-3h total GIP

    Time frame: baseline (Day -1) to Week 12

  36. change in glucagon

    Time frame: baseline (Day -1) to Week 4

  37. change in AUC 0-3h glucagon

    Time frame: baseline (Day -1) to Week 4

  38. change in glucagon

    Time frame: baseline (Day -1) to Week 12

  39. change in AUC 0-3h glucagon

    Time frame: baseline (Day -1) to Week 12

  40. change in 1,5 AG

    Time frame: baseline (Day -1) to Week 4

    1,5 AG = 1,5 anhydrogucitol

  41. change in AUC 0-3h 1,5 AG

    Time frame: baseline (Day -1) to Week 4

  42. change in 1,5 AG

    Time frame: baseline (Day -1) to Week 12

  43. change in AUC 0-3h 1,5 AG

    Time frame: baseline (Day -1) to Week 12

  44. change in total cholesterol

    Time frame: baseline (Day -1) to Week 2

  45. change in total cholesterol

    Time frame: baseline (Day -1) to Week 4

  46. change in total cholesterol

    Time frame: baseline (Day -1) to Week 8

  47. change in total cholesterol

    Time frame: baseline (Day -1) to Week 12

  48. change in HDL cholesterol

    Time frame: baseline (Day -1) to Week 2

    HDL = high density lipoprotein

  49. change in HDL cholesterol

    Time frame: baseline (Day -1) to Week 4

  50. change in HDL cholesterol

    Time frame: baseline (Day -1) to Week 8

  51. change in HDL cholesterol

    Time frame: baseline (Day -1) to Week 12

  52. change in LDL cholesterol

    Time frame: baseline (Day -1) to Week 2

    LDL = low density lipoprotein

  53. change in LDL cholesterol

    Time frame: baseline (Day -1) to Week 4

  54. change in LDL cholesterol

    Time frame: baseline (Day -1) to Week 8

  55. change in LDL cholesterol

    Time frame: baseline (Day -1) to Week 12

  56. change in triglyceride

    Time frame: baseline (Day -1) to Week 2

  57. change in triglyceride

    Time frame: baseline (Day -1) to Week 4

  58. change in triglyceride

    Time frame: baseline (Day -1) to Week 8

  59. change in triglyceride

    Time frame: baseline (Day -1) to Week 12

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
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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