Trials Sponsors Conditions Drugs Pricing

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.

Interventions

CS02 tablet and placebo tabletDrug

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 CS02low dose of CS02middle dose of CS02placebo control

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Center Laboratories, Inc.
Industrylead

Study Sites (13)

Applied Research Center of Arkansas, Inc.

Little Rock, Arkansas, 72212, United States

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

The Community Research of South Florida

Hialeah, Florida, 33016, United States

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

China Medical University Hospital

Taichung, 404, Taiwan

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: 35917580DERIVED

Enrollment

201 participants (actual enrollment reported by the registry).

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

Actual (reported)

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;

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

high dose of CS02

middle dose of CS02

low dose of CS02

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

placebo control

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

high dose of CS02

middle dose of CS02

low dose of CS02

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

placebo control

You may not qualify if:

Source record

Locations