T2DM With Inadequate Glycemic ControlPhase 2NCT03317028
CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)
A Phase 2 study of T2DM With Inadequate Glycemic Control, run by Center Laboratories, Inc. at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM With Inadequate Glycemic Control
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 10 Oct 2017to 21 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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);
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- 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;
- Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments, or inappropriate for inclusion per investigators, judgments;
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Taiwan10 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Chung Shan Medical University Hospital
Taichung, 402
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital
Taichung, 40705
Chi-Mei Medical Center
Tainan, 710
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans general Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
Chang Gung Memorial Hospital_Linkou
Taoyuan, 333
United States3 sites
Clinical Research of South Florida
Coral Gables, Florida, 33134
The Community Research of South Florida
Hialeah, Florida, 33016
Applied Research Center of Arkansas, Inc.
Little Rock, Arkansas, 72212
About this study
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
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
- Being tested
- CS02 tablet and placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| high dose of CS02 | Experimental | Subjects will receive 450mg of CS02 combined with a stable dose of metformin monotherapy. Receives: 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. Receives: 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. Receives: Drug: CS02 tablet and placebo tablet |
| placebo control | Placebo comparator | Subjects will receive placebo combined with a stable dose of metformin monotherapy. Receives: Drug: CS02 tablet and placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start10 Oct 2017
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DM With Inadequate Glycemic ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317028
- Sponsor's protocol ID
- CS02-001
- Status last verified
- Jun 2020
- First submitted
- 18 Oct 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 35917580
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03317028
- Acronym / sponsor ID
- CS02-001
- Conditions
- T2DM With Inadequate Glycemic Control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Center Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high dose of CS02 | Experimental | Drug: CS02 tablet and placebo tabletSubjects will receive 450mg of CS02 combined with a stable dose of metformin monotherapy. |
| middle dose of CS02 | Experimental | Drug: CS02 tablet and placebo tabletSubjects will receive 300mg of CS02 combined with a stable dose of metformin monotherapy. |
| low dose of CS02 | Experimental | Drug: CS02 tablet and placebo tabletSubjects will receive 150mg of CS02 combined with a stable dose of metformin monotherapy. |
| placebo control | Placebo comparator | Drug: CS02 tablet and placebo tabletSubjects will receive placebo combined with a stable dose of metformin monotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS02 tablet and placebo tabletSubjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment. | Drug | high dose of CS02, low dose of CS02, middle dose of CS02, placebo control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 35917580Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of T2DM With Inadequate Glycemic Control, run by Center Laboratories, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The HbA1c treatment effect among CS02 groups and the Placebo group (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.