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

Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 75
Start Date:October 10, 2017
End Date:March 31, 2021
Contact:Eric Shane
Phone:+886-2-2655 8680

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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.

Inclusion Criteria:

1. Subjects with diagnosis of type 2 diabetes mellitus at least 12 weeks prior to Visit

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

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

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

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

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;
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