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

NCT03317028 | Completed Phase 2 FDA Drug

• 1 other identifier: CS02-001
• Study Type: interventional
• Target: 201
• Locations: 2 countries
• Sites: 13

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.

Conditions

T2DM With Inadequate Glycemic Control

Outcome Measures

Primary Outcomes (1)

• The HbA1c treatment effect among CS02 groups and the Placebo group

  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

Study Arms (4)

high dose of CS02

EXPERIMENTAL

Subjects will receive 450mg of CS02 combined with a stable dose of metformin monotherapy.

Drug: CS02 tablet and placebo tablet

middle dose of CS02

EXPERIMENTAL

Subjects will receive 300mg of CS02 combined with a stable dose of metformin monotherapy.

Drug: CS02 tablet and placebo tablet

low dose of CS02

EXPERIMENTAL

Subjects will receive 150mg of CS02 combined with a stable dose of metformin monotherapy.

Drug: CS02 tablet and placebo tablet

placebo control

PLACEBO COMPARATOR

Subjects will receive placebo combined with a stable dose of metformin monotherapy.

Drug: CS02 tablet and placebo tablet

Interventions

CS02 tablet and placebo tablet DRUG

Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.

high dose of CS02; low dose of CS02; middle dose of CS02; placebo control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with diagnosis of type 2 diabetes mellitus at least 12 weeks prior to Visit 1;
• 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;
• Subjects with a stable diet and exercise program for ≧8 weeks prior to Visit 1;
• Subjects with HbA1c value ≧7.0% and ≦10.0% at Visit 1;
• Subjects with a stable dose of metformin monotherapy of ≥1500 mg/day at least 12 weeks before randomization (Visit 2);
• Body mass index (BMI) between 20.0 and 45.0 kg/m2at Visit 1;
• 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;
• Subjects have estimated glomerular filtration rate (e-GFR)\* values of≧ 45ml/min/1.73m2 at Visit1;
• 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;
• Willing to provide a written informed consent form;
• Willingness and ability to comply with treatment plans, scheduled visits, required laboratory tests, and other study procedures;

You may not qualify if:

• Subjects with type 1 diabetes mellitus, secondary diabetes mellitus, or gestational diabetes;
• Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma at Visit 1 or Visit 2;
• Subjects with hypotension (average systolic pressure \< 90 mm Hg\*) at Visit 1 or Visit 2;
• Subjects with cardiogenic shock within 8 weeks prior to Visit 1;
• Subjects with sick sinus syndrome, second- or third-degree atrioventricular block (AV block);
• Subjects with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes);
• Subjects with recurrence or history of transient ischemic attack or coronary artery bypass surgery;
• 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;
• Female subjects who are nursing or pregnant during the study period;
• 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;
• 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;
• Subjects have a history or current of substance or alcohol abuse;
• Subjects have uncontrolled psychiatric disorder(s);
• 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);
• Subjects have participated in another clinical trial within the last 12 weeks prior to Visit 1;

Sponsors & Collaborators

• Center Laboratories, Inc.: lead

Study Sites (13)

Applied Research Center of Arkansas, Inc.

Little Rock, Arkansas, 72212, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

The Community Research of South Florida

Hialeah, Florida, 33016, United States

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chi-Mei Medical Center

Tainan, 710, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Veterans general Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang Gung Memorial Hospital_Linkou

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Wang CY, Huang KC, Lu CW, Chu CH, Huang CN, Chen HS, Lee IT, Chen JF, Chen CC, Chen CS, Hsieh CH, Tien KJ, Chien HY, Huang YY, Hsu JP, Shane GT, Chang AC, Wu YC, Sheu WH. A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):e4063-e4071. doi: 10.1210/clinem/dgac436.

  PMID: 35917580 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: October 10, 2017
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

TW (10); US (3)