CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)

June 8, 2020 updated by: Center Laboratories, Inc.

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of CS02 Tablet in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

The objective of the study is to compare the efficacy and safety of 3 doses CS02 Tablet in combination with a stable dose of metformin monotherapy against CS02 PTM (placebo) Tablet in combination with a stable dose of metformin monotherapy over a 12 weeks treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin alone.

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.
201

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

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 710
        • Chi-Mei Medical Center
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital_Linkou
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas, Inc.
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Hialeah, Florida, United States, 33016
        • The Community Research of South Florida

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects with diagnosis of type 2 diabetes mellitus at least 12 weeks prior to Visit 1;
  2. Outpatient, either male or female, aged 20 years or older from Taiwan and aged 18 years or older from united States; all subjects are ≤75 years old;
  3. Subjects with a stable diet and exercise program for ≧8 weeks prior to Visit 1;
  4. Subjects with HbA1c value ≧7.0% and ≦10.0% at Visit 1;
  5. Subjects with a stable dose of metformin monotherapy of ≥1500 mg/day at least 12 weeks before randomization (Visit 2);
  6. Body mass index (BMI) between 20.0 and 45.0 kg/m2at Visit 1;
  7. Subjects have adequate liver function, defined as serum total bilirubin≤1.5 times the upper limit of normal (uLN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3 times uLN at Visit 1;
  8. Subjects have estimated glomerular filtration rate (e-GFR)* values of≧ 45ml/min/1.73m2 at Visit1;
  9. Female subjects of childbearing potential， defined as women≤ 55 years old or history of amenorrhea ≤ 12 months prior to the study entry or not surgically sterile, must have a negative pregnancy test at Visit 1 and agree to use a highly effective contraceptive method during the study period;
  10. Willing to provide a written informed consent form;
  11. Willingness and ability to comply with treatment plans, scheduled visits, required laboratory tests, and other study procedures;

Exclusion Criteria:

  1. Subjects with type 1 diabetes mellitus, secondary diabetes mellitus, or gestational diabetes;
  2. Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma at Visit 1 or Visit 2;
  3. Subjects with hypotension (average systolic pressure < 90 mm Hg*) at Visit 1 or Visit 2;
  4. Subjects with cardiogenic shock within 8 weeks prior to Visit 1;
  5. Subjects with sick sinus syndrome, second- or third-degree atrioventricular block (AV block);
  6. Subjects with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes);
  7. Subjects with recurrence or history of transient ischemic attack or coronary artery bypass surgery;
  8. Subjects with history of cerebrovascular attack, myocardial infarction, serious cardiac disease (New York Heart Association NYHA Class III to IV), left ventricular ejection fraction≦40% within 12 weeks prior to Visit 1, or those with cardiovascular disease or cerebrovascular disease that may affect the administration of IP tablets (CS02) or its safety assessment in the opinion of the investigator or sub-investigator;
  9. Female subjects who are nursing or pregnant during the study period;
  10. Subjects are on a weight loss program and not in the maintenance phase or have started a weight loss medication including but not limited to Orlistat, Phentermine, Osymia, or Belviq or have undergone bariatric surgery within 8 weeks prior to Visit 1 or any type of surgery planned during the study;
  11. Subjects with a clinically severe gastrointestinal disorder including diabetic gastroparesis; irritable bowel disease; recurrent episodes of nausea, vomiting, diarrhea and abdominal pain within 12 weeks prior to Visit 1;
  12. Subjects have a history or current of substance or alcohol abuse;
  13. Subjects have uncontrolled psychiatric disorder(s);
  14. Subjects are less than 5 years free of malignancy (except for cured basal cell carcinoma of skin and cured carcinoma in situ of the uterine cervix);
  15. Subjects have participated in another clinical trial within the last 12 weeks prior to Visit 1;
  16. Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments, or inappropriate for inclusion per investigators, judgments;

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: Double

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: high dose of CS02
Subjects will receive 450mg of CS02 combined with a stable dose of metformin monotherapy.
Drug: CS02 tablet and placebo tablet
Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.
Experimental: middle dose of CS02
Subjects will receive 300mg of CS02 combined with a stable dose of metformin monotherapy.
Drug: CS02 tablet and placebo tablet
Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.
Experimental: low dose of CS02
Subjects will receive 150mg of CS02 combined with a stable dose of metformin monotherapy.
Drug: CS02 tablet and placebo tablet
Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.
Placebo Comparator: placebo control
Subjects will receive placebo combined with a stable dose of metformin monotherapy.
Drug: CS02 tablet and placebo tablet
Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.

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
The HbA1c treatment effect among CS02 groups and the Placebo group
Time Frame: 12 weeks
To assess 208 evaluable subject of the change in HbA1c from baseline to end of treatment among CS02 groups and CS02 placebo to match group will be compared with the analysis of covariance model including baseline HbA1c as covariate, and treatment groups and regions as fixed effects.
12 weeks

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.
Center Laboratories, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
October 10, 2017

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.
April 21, 2020

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.
April 21, 2020

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).
October 18, 2017

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.
October 18, 2017

First Posted (Actual)

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.
October 23, 2017

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.
June 9, 2020

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.
June 8, 2020

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.
June 1, 2020

More Information

Terms related to this study

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.
  • CS02-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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Locations

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