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Type 2 Diabetes MellitusPhase 2NCT04124484

DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

A Phase 2 study of Type 2 Diabetes Mellitus, 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

This study evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
1 siteChina
Study dates
17 Oct 2017to 28 Jun 2019
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 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:
  • Initial diagnosis of type 2 diabetes mellitus;
  • Patients who with type 2 diabetes diagnosed within 2 years before 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 (i.e., continuous medication for <1 week);
  • 19kg/m^2 ≤ Body Mass Index（BMI ）≤ 35kg/m^2;
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  • 7.0% ≤ HbA1c ≤ 10.0%;
  • Female subjects of childbearing age are negative in pregnancy test;
  • All the subjects do not have a fertility plan during and three month after the trial;
  • Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;

Who cannot join

  • FPG > 15 mmol/L;
  • Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg during screening period;
  • Those who are known to be positive for HIV and syphilis;
  • known active hepatitis B virus infection, hepatitis C virus infection;
  • For patients with obvious liver diseases and chronic liver diseases, AST or ALT in screening stage was twice the normal upper limit.
  • In patients with renal insufficiency, serum creatinine at screening stage was 1.5 times higher than the upper limit of normal value;
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  • Leukocyte and hemoglobin < lower limit of normal value, triglyceride > 5.7 mmol/L in screening stage;
  • With diabetic acute complications (including diabetic ketoacidosis, hypertonic non-ketoacid diabetic coma, lactic acidosis and hypoglycemic coma), chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
  • Use of insulin, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist or any combination of two or more oral hypoglycemic drugs within 8 weeks before screening time.
  • Those who need insulin therapy;
  • Using and Used of glucocorticoids within 2 weeks before screening time.
  • without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）>500ms or atrial fibrillation during 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;
  • Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or chronic intestinal diseases associated with digestive and absorption diseases;
  • Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
  • History of severe hypoglycemia;
  • History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
  • Pregnancy, lactating women;
  • Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
  • Not suitable for this clinical trial judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Hospital of Peking Unversity

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus

This study evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group.

Read the detailed description

This study was to evaluate DRBP108 in the treatment of type 2 diabetes mellitus. A total of 268 subjects were randomly allocated to four treatment arms: 50 mg, 100 mg, 200 mg or placebo group, in a 1:1:1:1 ratio.

Being tested
DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg), DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg), DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)
Keywords
DBPR108, type 2 diabetes mellitus, DPP4 inhibitor
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.

  • DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)Drug

    One DBPR108 tablet(50mg) administered orally once a day + Two Placebos matching DBPR108 tablet(100mg) administered orally once a day for 12 weeks

  • DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)Drug

    One DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks

  • DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)Drug

    Two DBPR108 tablets(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks

  • Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)Drug

    Two Placebos matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks

Study groups in NCT04124484
Study groupRoleWhat they receive
50mg groupExperimentalParticipants received one 50mg of DBPR108 tablet and two placebos matching DBPR108 100mg under fasted conditions for one day.
Receives: Drug: DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)
100mg groupExperimentalParticipants received one 100mg of DBPR108 tablet and two placebos matching DBPR108 50mg and 100mg under fasted conditions for one day.
Receives: Drug: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)
200mg groupExperimentalParticipants received two 100mg of DBPR108 tablets and one placebo matching DBPR108 50mg under fasted conditions for one day.
Receives: Drug: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)
placebo groupPlacebo comparatorParticipants received two placebo matching DBPR108 100mg and one placebo matching DBPR108 50mg
Receives: Drug: Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)

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 12

    Measured: Baseline, week 12

Secondary outcomes (8)

  1. HBA1c

    Changes in HbA1c compared to baseline at week 8, week 4

    Measured: Baseline, week 8, week4

  2. Fasting plasma glucose

    Changes in Fasting plasma glucose compared to baseline at week 4,week 8, week 12

    Measured: Baseline, week 4，week 8, week 12

  3. 2-hour postprandial plasma glucose

    Changes in 2-hour postprandial plasma glucose compared to baseline at week 4,week 8, week 12

    Measured: Baseline, week 4，week 8, week 12

  4. fasting glucagon

    Changes in fasting glucagon compared to baseline at week 4,week 8, week 12

    Measured: Baseline, week 4，week 8, week 12

  5. fasting Insulin

    Changes in fasting Insulin compared to baseline at week 4,week 8, week 12

    Measured: Baseline, week 4，week 8, week 12

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

    Changes in active（GLP-1）compared to baseline at week 4,week 8, week 12

    Measured: Baseline, week 4，week 8, week 12

  7. The percentage of HbA1c≤6.5% or HbA1c≤7%

    The percentage of HbA1c≤6.5% or HbA1c≤7% at week 12

    Measured: week 12

  8. body weight

    Changes in body weight（Kg）compared to baseline at week 4,week 8, week 12

    Measured: Baseline, week 4，week 8, week 12

Timeline

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

  1. First posted11 Oct 2019
  2. Study start17 Oct 2017
  3. Primary completion27 Feb 2019
  4. Study completion28 Jun 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04124484
Sponsor's protocol ID
CSPC/HA1117/PRO-II
Status last verified
Jul 2019
First submitted
8 Jul 2019
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang W, Yao J, Guo X, Guo Y, Yan C, Liu K, Zhang Y, Wang X, Li H, Wen Z, Wang X, Li S, Xiao X, Liu W, Li Z, Zhang L, Shao S, Ye S, Qin G, Li Y, Li F, Zhang X, Li X, Peng Y, Deng H, Xu X, Zhou L, Huang Y, Cao M, Xia X, Shi M, Dou J, Yuan J. Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial. Curr Med Res Opin. 2020 Jul;36(7):1107-1115. doi: 10.1080/03007995.2020.1761311. Epub 2020 May 12.

    PubMed 32338063

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Type 2 Diabetes Mellitus, 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 20 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 15 Oct 2019. 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 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?

HBA1c (time frame: Baseline, week 12). 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 NCT04124484, 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 15 Oct 2019.

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