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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 : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Center Laboratories, Inc.

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.

Condition or disease Intervention/treatment Phase
T2DM With Inadequate Glycemic Control Drug: CS02 tablet and placebo tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317028


Contacts
Contact: Eric Shane +886-2-2655 8680 ext 621 eric_shane@centerlab.comtw

Locations
United States, Florida
Clinical Research of South Florida Recruiting
Coral Gables, Florida, United States, 33134
Contact: Rosen Jeffrey, MD    305-445-5637    jrosen@crsouthflorida.com   
Principal Investigator: Rosen Jeffrey, MD         
The Community Research of South Florida Recruiting
Hialeah, Florida, United States, 33016
Contact: Carpio Jose, MD    305-441-6611    jcarpio@thecommunityresearch.com   
Principal Investigator: Carpio Jose, MD         
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Contact: Chih-Hsun Chu, MD    +886-7-3422-121 ext 8089    chchu@vghks.gov.tw   
Principal Investigator: Chih-Hsun Chu, MD         
Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 833
Contact: Jung-Fu Chen, MD    +886-7-733-7166    0722cjf@cgmh.org.tw   
Principal Investigator: Jung-Fu Chen, MD         
Chung Shan Medical University Hospital Not yet recruiting
Taichung, Taiwan, 402
Contact: Chien-Ning Huang, MD    +886-4-2473-9595 ext 11600    cshy049@csh.org.tw   
Principal Investigator: Chien-Ning Huang, MD         
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 404
Contact: Ching-Chu Chen, MD    +886-4-2206-2121 ext 3489    d1918@mail.cmuh.org.tw   
Principal Investigator: Ching-Chu Chen, MD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: I-Te Lee, MD, PhD    +886-933-553-211    itlee@vghtc.gov.tw   
Principal Investigator: I-Te Lee, MD, PhD         
Chi-Mei Medical Center Not yet recruiting
Tainan, Taiwan, 710
Contact: Kai-Jen Tien, MD    +886-6-2816-31    tkzzkimo@gmail.com   
Principal Investigator: Kai-Jen Tien, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Chih-Yuan Wang, MD, PhD    +886-938-036-246    cyw1965@gmail.com   
Principal Investigator: Chih-Yuan Wang, MD, PhD         
Taipei Veterans general Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Harn-Shen Chen, MD, PhD    +886-2-2875-7516    chenhs@vghtpe.gov.tw   
Principal Investigator: Harn-Shen Chen, MD, PhD         
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Chang-Hsun Hsieh, MD    +886-2-8792-7182    10324@yahoo.com.tw   
Principal Investigator: Chang-Hsun Hsieh, MD         
Chang Gung Memorial Hospital_Linkou Not yet recruiting
Taoyuan, Taiwan, 333
Contact: Yu-Yao Huang, MD, PhD    +886-975-368-137    yyh@cgmh.org.tw   
Principal Investigator: Yu-Yao Huang, MD, PhD         
Sponsors and Collaborators
Center Laboratories, Inc.

Responsible Party: Center Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03317028     History of Changes
Obsolete Identifiers: NCT03308695
Other Study ID Numbers: CS02-001
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs