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NCT Number: NCT02669732

An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp

The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.

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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

Not applicable

Primary location

SOUSEIKAI Hakata Clinic

Hakata-ku, Fukuoka, 812-0025, Japan

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 < 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

Drug

tablets

Placebo

Drug

tablets

Primary outcomes

  1. First-phase and Second-phase secretion Insulin

    Time frame: Baseline to Day 28 (Period 1 and 2)

    First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)

  2. First-phase and Second-phase secretion C-peptide

    Time frame: Baseline to Day 28 (Period 1 and 2)

    First-phase and Second-phase secretion (C-peptide)

Secondary outcomes

  1. M value

    Time frame: Baseline to Day 28 (Period 1 and 2)

    M value：Mean of Glucose Infusion Rate from 90 to 120 min

  2. M/I value

    Time frame: Baseline to Day 28 (Period 1 and 2)

    M/I value：M value / steady-state Insulin

  3. Disposition Index

    Time frame: Baseline to Day 28 (Period 1 and 2)

    Disposition Index：Product of M value and First-phase secretion

  4. Number and severity of Adverse Events

    Time frame: Day 28 (Period 1 and 2)

  5. plasma concentration of DS-8500a

    Time frame: Day 28 (Period 1 and 2)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 1, 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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