Clinical Trials List
2017-10-01 - 2021-03-31
Phase II
Recruiting2
Terminated10
ICD-10E10.9
Type 1 diabetes mellitus without complications
ICD-10E11
Type 2 diabetes mellitus
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
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
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
Center Laboratories, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chun-Jui Huang Division of Endocrinology
The Actual Total Number of Participants Enrolled
8 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李宇璇 Division of Endocrinology
- 林時逸 Division of Endocrinology
- 陳威麟 Division of Endocrinology
- JUN-SING WANG Division of Endocrinology
- 沈宜靜 Division of Endocrinology
- 謝雅湄 Division of Endocrinology
- 許惠恒 Division of Endocrinology
- 李昂澤 Division of Endocrinology
- 蔡易婷 Division of Endocrinology
- 李佳霖 Division of Endocrinology
- 傅家保 Division of Endocrinology
- 林涵薇 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 王誌慶 Division of Endocrinology
- Chih-Yiu Tsai Division of Endocrinology
- Wen-Cong Lu Division of Endocrinology
- 陳怡文 Division of Endocrinology
- 林承緯 Division of Endocrinology
- Jia-Hong Lin Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- 張皓翔 Division of Family Medicine
- 盧佳文 Division of Family Medicine
- 姚建安 Division of Family Medicine
- 蔡詩力 Division of Family Medicine
- 賴瑩純 Division of Endocrinology
- 楊昆澈 Division of Family Medicine
- CHIH-YUAN WANG Division of Endocrinology
- Kuo-Chin Huang Division of Family Medicine
- 江建勰 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Assessment of the change in hemoglobin A1c (HbA1c) from baseline to end of treatment.
Secondary Endpoint
Assessment of the change in HbA1c from baseline to each evaluation time point.
Percentage of subjects achieving the target HbA1c (< 6.5% and < 7.0%) at each
evaluation time point.
Assessment of the change in fasting plasma glucose (FPG) level and fasting insulin
level.
Plasma glucose, insulin, and C-peptide of 2-h oral glucose tolerance test (OGTT).
Homeostasis model2 assessment β-cell (HOMA2-β) calculation.
Homeostasis model2 assessment insulin resistance (HOMA2-IR) calculation.
The proportion of subjects requiring rescued medication.
The proportion of subjects who meet the discontinuation criteria (FPG ≧ 260 mg/dL
for two consecutive measurements, not including values measured by glucometer).
Urine micro-albumin and the related cardiovascular risk factors (e.g., total cholesterol
[TC], triglyceride [TG], low-density lipoprotein [LDL], high-density lipoprotein [HDL]
and NT-proBNP (depends on local site practice and feasibility)), body weight, and waist
circumference.
The IP exposure-response (pharmacokinetics-pharmacodynamics) of serum trough
concentrations (Ctrough) at steady state.
Safety Evaluation
Adverse events, which include the incidence rates of Gastrointestinal (GI) adverse experiences e.g., nausea, vomiting, diarrhea, and abdominal pain
Outstanding findings or clinically significant abnormal changes in vital signs,
laboratory tests, and 12-lead electrocardiogram (ECG) tests
Vital signs and laboratory tests.
Occurrence of hypotension and hypoglycemic events
Inclution Criteria
Patients who meet all of the following will be included in the study:
(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, AND do not meet
any of the discontinuation criteria of fasting plasma glucose (FPG) at Visit 2;
(5) Subjects with a stable dose of metformin monotherapy of ≥ 1500 mg/day or on
maximally tolerated dose for patients who cannot titrate up to 1500 mg/day due to
safety concerns or side effect of metformin per investigator’s judgments at least 12
weeks before randomization (Visit 2);
(6) Body mass index (BMI) between 20.0 and 45.0 kg/m2
at 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 ≧ 45
ml/min/1.73m2
at Visit 1;
*e-GFR (ml/min/1.73m2
) from the Modification of Diet in Renal Disease (MDRD)
Study = 175x(Scr, std)-1.154
xAge-0.203
x(0.742 if female)x(1.212 if African American)
Scr, std: serum creatinine measured with a standardized assay.
(9) Female subjects of childbearing potential, defined as women ≤ 55 years old or
history of amenorrhea ≤ 12 months prior to 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;
(11) Willingness and ability to comply with treatment plans, scheduled visits, required
laboratory tests, and other study procedures;
Exclusion Criteria
Patients who meet any of the following will be excluded from the study:
(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;
*: Systolic blood pressure shall be measured after at least 5 minutes resting in a
seated position with three times at 1-2 minute-intervals in the same arm using the
same procedures. The average value of the 2 highest measurement obtained at the
visit will be the systolic blood pressure value.
(4) Subjects with cardiogenic shock within 8 weeks prior to Visit 1;
(5) Subjects with sick sinus syndrome including but not limited to sinus bradycardia
(ventricular rate < 50 beats/ min), second- or third-degree atrioventricular block (AV
block) (except patients with a functioning artificial ventricular pacemaker);
(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) Subjects with insulin administration within 12 weeks prior to Visit 1 (insulin for
emergency ≦ 7 consecutive days is allowed);
(10) Subjects with severe infection, serious trauma, or perioperative period at Visit 1 or
Visit 2;
(11) Subjects with more than four types of anti-hypertensive agents;
(12) Subjects current under treatment with verapamil for hypertension;
(13) Female subjects who are nursing or pregnant during the study period;
(14) 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;
(15) Subjects are on or are likely to require treatment with at least 14 consecutive days or
repeated course of pharmacologic doses of corticosteroids or chemotherapy or any
other immune-modulatory agents, but does not include topical or inhaled
corticosteroids, within 8 weeks prior to Visit 1. Exceptions are over the counter non-salicylate NSAIDs;
(16) 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;
(17) Subjects have a history or current of substance or alcohol abuse;
(18) Subjects with uncontrolled psychiatric disorder(s);
(19) 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);
(20) Subjects have participated in another clinical trial within the last 12 weeks prior to
Visit 1;
(21) Subjects who are considered unreliable as to medication compliance or adherence to
scheduled appointments, or inappropriate for inclusion per investigators’ judgments;
The Estimated Number of Participants
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Taiwan
136 participants
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Global
295 participants
