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Completed

NCT Number: NCT02685345

A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yodogawaku, Osaka, 565-0853, Japan

About this study

In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Japanese patients with type 2 diabetes
  • Patients aged ≥ 20 years at the time of informed consent
  • Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
  • Patients who have HbA1c ≥ 7.0% and < 9.0%

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 25 mg

Drug

DS-8500a 75 mg

Drug

Placebo

Drug

Primary outcomes

  1. change in 24 hour weighted mean glucose

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

Secondary outcomes

  1. change in fasting plasma glucose

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

  2. change in plasma glucose

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

    Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal

  3. change in glycoalbumin

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

  4. change in serum insulin

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

    Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal

  5. change in proinsulin

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

  6. change in C-peptide

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

    Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

  7. change in PYY (pancreatic peptide YY3-36)

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

    Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

  8. change in total GLP-1 (Glucagon-like peptide-1)

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

  9. change in active GLP-1 (Glucagon-like peptide-1)

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

    Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

  10. change in total GIP (Gastric inhibitory polypeptide)

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

    Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

  11. change in total glucagon

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

    Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

  12. change in total total cholesterol

    Time frame: baseline (Day -1) to after dosing on Day 28

  13. change in total HDL (high density lipoprotein) cholesterol

    Time frame: baseline (Day -1) to after dosing on Day 28

  14. change in total LDL (low density lipoprotein) cholesterol

    Time frame: baseline (Day -1) to after dosing on Day 28

  15. change in total triglyceride

    Time frame: baseline (Day -1) to after dosing on Day 28

  16. number and severity of adverse events

    Time frame: baseline (Day -1) to after dosing on Day 28

  17. change in derived plasma glucose AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h

  18. change in derived serum insulin AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h

  19. change in derived C-peptide AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from C-peptide; AUC0-4h

  20. change in derived PYY AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from PYY; AUC0-4h

  21. change in derived total GLP-1 AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h

  22. change in derived active GLP-1 AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h

  23. change in derived total GIP AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from total GIP; AUC0-4h

  24. change in derived glucagon AUC

    Time frame: baseline (Day -1) to after dosing on Day 28

    change in pharmacodynamic parameters derived from glucagon; AUC0-4h

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Collaborators

  • Mediscience Planning, Inc.

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2016
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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