12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

February 8, 2019 updated by: Daiichi Sankyo, Inc.

A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
298

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1W 4R4
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 4A1
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
      • London, Ontario, Canada, N5W 6A2
      • Newmarket, Ontario, Canada, L3Y 5GB
      • Toronto, Ontario, Canada, M9W 4L6
      • Toronto, Ontario, Canada, M9V 4B4
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
      • Montreal, Quebec, Canada, H4N 2W2
      • Sherbrooke, Quebec, Canada, J1H 1Z1
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
      • Tempe, Arizona, United States, 85282
    • California
      • Anaheim, California, United States, 92801
      • Chino, California, United States, 91710
      • Chula Vista, California, United States, 91911
      • Fresno, California, United States, 93720
      • Gold River, California, United States, 95670
      • Greenbrae, California, United States, 94904
      • San Diego, California, United States, 92103
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
      • Lakewood, Colorado, United States, 80227
    • Florida
      • Hallandale Beach, Florida, United States, 33009
      • Miami, Florida, United States, 33126
      • Miami, Florida, United States, 33135
      • Pembroke Pines, Florida, United States, 33026
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30331
    • Idaho
      • Boise, Idaho, United States, 83704
    • Indiana
      • Avon, Indiana, United States, 46123
      • Evansville, Indiana, United States, 47725
      • Franklin, Indiana, United States, 46131
      • Greenfield, Indiana, United States, 46140
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
    • Michigan
      • Troy, Michigan, United States, 48098
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • Missouri
      • Washington, Missouri, United States, 63090
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • North Carolina
      • Mooresville, North Carolina, United States, 28117
      • Morgantown, North Carolina, United States, 28655
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Columbus, Ohio, United States, 43213
    • Oregon
      • Medford, Oregon, United States, 97504
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Charleston, South Carolina, United States, 29407
      • Greer, South Carolina, United States, 29651
      • Mount Pleasant, South Carolina, United States, 29464
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77036
      • Plano, Texas, United States, 75024
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78228
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84102
      • South Jordan, Utah, United States, 84095
    • Virginia
      • Burke, Virginia, United States, 22015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to provide written informed consent and adhere to the study visit schedule and treatment
  • Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015
  • Male or female ≥ 18 and ≤ 70 years of age
  • Screening fasting C-peptide > 0.5 ng/mL
  • Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study
  • WOCBP must have a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) before entering the Lead-in Period
  • Body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2 at the Screening Visit
  • On stable (≥ 8 weeks) metformin monotherapy ≥ 1000 mg/day
  • Screening HbA1c ≥ 7.0% and ≤ 10%
  • Taking ≥ 80% and ≤ 120% of both dispensed DS-8500a placebo tablets and sitagliptin placebo capsules during the Lead-in Period

Exclusion Criteria:

  • History of type 1 diabetes and/or history of ketoacidosis
  • History of insulin use for > 2 weeks within 2 months prior to the Screening Visit
  • Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) > 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of > 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement
  • Screening hemoglobin <12 g/dL for males and <11 g/dL for females
  • Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study
  • Subjects after bariatric surgery or any gastric bypass
  • Screening thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values )
  • Screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2.0 x upper limit of normal (ULN), and/or total bilirubin > 1.5 x ULN. If a subject has total bilirubin > 1.5 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled
  • Screening Serum creatinine ≥ 1.5 mg/dL for males and ≥ 1.4 mg/dL for females, or creatinine clearance (CrCl) < 50 mL/min for both males and females
  • Screening Creatine kinase (CK) > 3.0 × ULN
  • History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period
  • History of congestive heart failure (CHF)

  • Exclusionary concomitant medications:

    a. Eight weeks prior to screening and throughout the duration of the study:

  • Any diabetes medication other than metformin; any prescription or over the counter medication for weight-loss.
  • Systemic corticosteroids (including nasal and inhaled), with the exception of use of topical and ophthalmic corticosteroids.
  • Rosuvastatin > 20 mg daily. b. During treatment periods, additional medications will be prohibited based on potential drug-drug interaction (DDI) (see Section 5.6)
  • Subjects with anticipated interruption in metformin or study drug use during the course of the clinical trial (e.g., due to an imaging procedure involving iodinated contrast media)
  • Subjects in whom treatment with sitagliptin 100 mg is contraindicated ( e.g., known hypersensitivity or intolerance to sitagliptin) or may not be medically advisable (e.g., history of pancreatitis)
  • Abuse of or dependence on prescription medications, illicit drugs, or alcohol within the last 1 year
  • Any history of a malignancy other than basal cell carcinoma within the past 5 years
  • Pregnancy or breast-feeding, or intent to become pregnant during the study period
  • Known (or evidence of) infection with human immunodeficiency virus
  • Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject's best interest
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
  • A direct or familial relationship with the Sponsor, Investigator, or site personnel affiliated with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DS-8500a 25mg
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
Drug: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Other Names:
  • Investigational product
Drug: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Other Names:
  • Placebo
Drug: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Other Names:
  • Placebo
Experimental: DS-8500a 50 mg
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
Drug: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Other Names:
  • Investigational product
Drug: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Other Names:
  • Placebo
Drug: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Other Names:
  • Placebo
Experimental: DS-8500a 75 mg
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
Drug: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Other Names:
  • Investigational product
Drug: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Other Names:
  • Placebo
Placebo Comparator: Placebo
Three placebo tablets and one placebo capsule in a once-daily oral dose
Drug: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Other Names:
  • Placebo
Drug: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Other Names:
  • Placebo
Active Comparator: Sitagliptin 100 mg
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
Drug: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Other Names:
  • Placebo
Drug: Sitagliptin 100 mg
Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time Frame: Baseline, Week 12
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Cholesterol (TC) at Week 12
Time Frame: Baseline, Week 12
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Baseline, Week 12
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline, Week 12
LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.
Baseline, Week 12
Change From Baseline in HDL-C at Week 12
Time Frame: Baseline, Week 12
HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.
Baseline, Week 12
Change From Baseline in Non-HDL-C at Week 12
Time Frame: Baseline, Week 12
Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).
Baseline, Week 12
Change From Baseline in Triglycerides at Week 12
Time Frame: Baseline, Week 12
Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.
Baseline, Week 12
Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4
Time Frame: Baseline, Week 4
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Baseline, Week 4
Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12
Time Frame: Baseline, Week 12
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Baseline, Week 12
Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4
Time Frame: Baseline, Week 4
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Baseline, Week 4
Change From Baseline in Cmax of PG in Response to MMTT at Week 12
Time Frame: Baseline, Week 12
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2
Time Frame: Baseline, Week 2
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4
Time Frame: Baseline, Week 4
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8
Time Frame: Baseline, Week 8
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time Frame: Baseline, Week 12
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 12
Count of Participants With HbA1c Less Than 7.0% at Week 12
Time Frame: Week 12
HbA1C less than 7% is the success goal for many Type 2 diabetics.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS8500-A-U202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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