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Diabetes Mellitus, Type 2Phase 3NCT03940183

Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes

A Phase 3 study testing Trelagliptin Succinate in people with Diabetes Mellitus, Type 2, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The trial used a randomized, double-blind, placebo-controlled, superior-effect design, multicenter clinical study. The trial was divided into a test group and a placebo group,the two groups were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Trelagliptin Succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
1 siteChina
Study dates
8 Jul 2019to 28 Dec 2020
Phase
Phase 3
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 who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
  • Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
  • 18 ≤ age ≤ 75 years old, male or female;
  • One of the following conditions:
  • Initially diagnosed type 2 diabetic patients;
  • Patients who with type 2 diabetes diagnosed within 2 years of screening period and are treated with single-agent oral hypoglycemic agents until screening, and do not take the medicine regularly for at least 8 weeks (ie, continuous medication for <1 week);
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  • 19kg/m^2 ≤ Body Mass Index（BMI ）≤ 35kg/m^2;
  • 7.0% ≤ HbA1c ≤ 10.0%;
  • Female subjects of childbearing age are negative in pregnancy test;
  • Female subjects do not have a fertility plan one month before the trial and all the subjects do not have a fertility plan during and one month after the trial.

Who cannot join

  • Fasting plasma glucose≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.8mmol/L);
  • Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg during screening;
  • Positive for Acquired Immure Deficiency Syndrome（AIDS）or syphilis testing;
  • Active hepatitis B virus infection or hepatitis C virus infection;
  • History of acute or chronic liver disease, and Aspartate aminotransferase(AST) or Alanine minotransferase(ALT)> 2.5 times of reference range or total bilirubin> 1.5 times of reference range during the screening period;
  • Renal insufficiency subjects, the serum creatinine above 1.5 times of reference range during the screening period;
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  • The white blood cells are outside of the reference range, hemoglobin below the reference range, triglyceride>5.7mmol/L during the screening period;
  • Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma) ,or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
  • Oral or intravenous use of glucocorticoids or regular application (ie continuous use more than one week within 4 weeks before screening time) with large doses of thiazide diuretics (hydrochlorothiazide, chlorothiazide, etc.);
  • Subjects without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）>450ms or atrial fibrillation during the screening period;
  • Active heart disease (including acute myocardial infarction, unstable angina) , moderate to severe congestive heart failure (NYHA class III or IV), or planned for coronary artery bypass grafting or transmyocardial laser revascularization half year before the screening period.
  • History of epilepsy, mental illness, major depression,or previous thyroid function abnormal and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease;
  • Endocrine diseases such as hypercortisolism or polycystic ovary syndrome that may affect blood glucose levels;
  • Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or obvious digestive and dysfunction chronic bowel disease;
  • Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
  • Using weight loss surgery within 3 months before screening period or using weight-loss drugs (including traditional Chinese medicine diet pills) within2 months before screening period;
  • History of drug or drug abuse or alcoholics;
  • Blood donation within 2 months before screening includes blood components or massive blood loss (≥400mL),or receiving blood transfusion or using blood products;
  • History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
  • Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
  • Pregnancy (defined as positive in pregnancy test), lactating women;
  • Not suitable for this clinical trial judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes

The trial used a randomized, double-blind, placebo-controlled, superior-effect design, multicenter clinical study.

The trial was divided into a test group and a placebo group,the two groups were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up.

Read the detailed description

The trial was divided into a test group and a placebo group: the test group was given trelagliptin succinate tablets, and the placebo group was given placebo. The test group and the placebo group were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up.

All subjects were asked to continue their current diabetes diet and physical activity treatment plan throughout the study period.

Being tested
Trelagliptin Succinate, Placebo Oral Tablet
Keywords
type 2 diabetes, monotherapy, trelagliptin succinate
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trelagliptin SuccinateDrug

    the experimental group will use trelagliptin succinate 100 mg for 24weeks

  • Placebo Oral TabletDrug

    the placebo Comparator groups use placebo oral tablet for 24weeks

Study groups in NCT03940183
Study groupRoleWhat they receive
Trelagliptin succinate 100 mgExperimentalTablets,100mg per tablet,oral, once a week, 100mg each time, continuous medication for a total of 24 weeks
Receives: Drug: Trelagliptin Succinate
Placebo Oral TabletPlacebo comparatorTablets,N/A,oral, once a week, one tablet each time, continuous medication for a total of 24 weeks
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Changes in HbA1c compared to baseline at week 24

    Measured: Baseline, week 24

Secondary outcomes (9)

  1. HbA1c

    Changes in HbA1c compared to baseline at week 16

    Measured: Baseline, week 16

  2. Fasting blood glucose

    Changes in Fasting blood glucose compared to baseline at week 16,week 24

    Measured: Baseline, week 16，week 24

  3. 2-hour postprandial blood glucose

    Changes in 2-hour postprandial blood glucose compared to baseline at week 24

    Measured: Baseline, week 24

  4. fasting insulin

    Changes in fasting insulin compared to baseline at week 24

    Measured: Baseline, week 24

  5. fasting glucagon

    Changes in fasting glucagon compared to baseline at week 24

    Measured: Baseline, week 24

  6. active Glucagon-like peptide-1（GLP-1） level

    Changes in active Glucagon-like peptide-1（GLP-1） level compared to baseline at 24

    Measured: Baseline, week 24

  7. The percentage of HbA1c<6.5% and HbA1c<7%

    The percentage of HbA1c<6.5% and HbA1c<7% at week 24

    Measured: week 24

  8. body weight

    Changes in body weight（Kg）compared to baseline at week 24

    Measured: Baseline, week 24

  9. Body Mass Index

    Changes in Body Mass Index （kg/m^2）compared to baseline at week 24

    Measured: Baseline, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2019
  2. Study start8 Jul 2019
  3. Primary completion3 Dec 2020
  4. Study completion28 Dec 2020

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03940183
Sponsor's protocol ID
CSPC/HC1425/201801
Status last verified
Jun 2020
First submitted
15 Apr 2019
Last updated
12 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trelagliptin Succinate in people with Diabetes Mellitus, Type 2, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

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 10 inclusion and 22 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

HbA1c (time frame: Baseline, week 24). 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 NCT03940183.

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 12 Jan 2021.

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