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

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ClinicalTrials.gov Identifier: NCT03317028
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Center Laboratories, Inc.

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE October 10, 2017
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03317028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE T2DM With Inadequate Glycemic Control
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: high dose of CS02
    Subjects will receive 450mg of CS02 combined with a stable dose of metformin monotherapy.
    Intervention: Drug: CS02 tablet and placebo tablet
  • Experimental: middle dose of CS02
    Subjects will receive 300mg of CS02 combined with a stable dose of metformin monotherapy.
    Intervention: Drug: CS02 tablet and placebo tablet
  • Experimental: low dose of CS02
    Subjects will receive 150mg of CS02 combined with a stable dose of metformin monotherapy.
    Intervention: Drug: CS02 tablet and placebo tablet
  • Placebo Comparator: placebo control
    Subjects will receive placebo combined with a stable dose of metformin monotherapy.
    Intervention: Drug: CS02 tablet and placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Shane +886-2-2655 8680 ext 621 eric_shane@centerlab.comtw
Listed Location Countries  ICMJE Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317028
Other Study ID Numbers  ICMJE CS02-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Center Laboratories, Inc.
Study Sponsor  ICMJE Center Laboratories, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Center Laboratories, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP