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Type 2 Diabetes MellitusPhase 3NCT04161430

A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients

A Phase 3 study of Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites 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 will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
766 participants
Where
2 sitesChina
Study dates
2 Jan 2020to 27 Jun 2022
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 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;
  • 19kg/m^2 ≤ Body Mass Index（BMI ）≤ 35kg/m^2;
  • Subjects with type 2 diabetes mellitus who did not regularly take oral hypoglycemic drugs at least 8 weeks before screening (i.e., continuous medication for <1 week);
  • 7.0% ≤ HbA1c ≤ 9.5%;
  • Subjects voluntarily participate in the trial and sign the informed consent form;
  • Subjects agree to use contraception from the signing of the informed consent form to the end of 1 month of the last medication.

Who cannot join

  • FPG > 13.9 mmol/L;
  • A history of severe hypoglycemia (that is, hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
  • A history of allergy to similar drugs (DPP-4 inhibitors) or those who have been judged by the investigator to be allergic to tested drugs;
  • Uncured hyperthyroidism or other diseases may cause secondary blood sugar elevation;
  • Continuous use of glucocorticoids within 4 weeks prior to screening or may uninterrupted use glucocorticoids ≥14 days during the trial (except for external use and inhalation)
  • Subjects with chronic bowel disease associated with inflammatory bowel disease, partial intestinal obstruction, or obvious digestive and absorption disorders;
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  • Subjects with infectious diseases(all positive for HBsAg, HBeAg, HBcAb, or positive for hepatitis C antibody, or positive for anti-HIV antibody); Female subjects of childbearing age are positive in pregnancy test or are lactating;
  • Subjects with a history of alcoholism or drug abuse;
  • Subjects have the clinically significant unstable diseases;
  • Not suitable for this clinical trial judged by the investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100000

  • the No, 1 People's Hospital of Changsha

    Changsha, Huan Province, 410005

Other trials in China

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Comparator, Placebo-Controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus

This study will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. The purpose of this study is to evaluate whether 24 weeks of DRBP108 treatment will adequately reduce hemoglobin A1C levels in T2DM subjects.

Being tested
DBPR108; Placebo matching sitagliptin, Placebo matching DBPR108; Sitagliptin; DBPR108, Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108
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; Placebo matching sitagliptinDrug

    Phase A (Weeks 1-24): DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.

    Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

  • Placebo matching DBPR108; Sitagliptin; DBPR108Drug

    Phase A (Weeks 1-24): Placebo matching DBPR108 100mg once daily under fasted conditions for 24 weeks; Sitagliptin 100 mg once daily under fasted conditions for 24 weeks.

    Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

  • Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108Drug

    Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.

    Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

Study groups in NCT04161430
Study groupRoleWhat they receive
DRBP108ExperimentalPhase A (Weeks 1-24): DBPR108 100mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg
Receives: Drug: DBPR108; Placebo matching sitagliptin
SitagliptinActive comparatorPhase A (Weeks 1-24): Placebo matching DBPR108 100 mg + Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg
Receives: Drug: Placebo matching DBPR108; Sitagliptin; DBPR108
PlaceboPlacebo comparatorPhase A (Weeks 1-24): Placebo matching DBPR108 100 mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg
Receives: Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108

What is being measured

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

  1. Change from baseline in HbA1c (%) compared to placebo comparator at week 24

    Change reflects the experimental value (baseline subtract) minus the placebo comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.

    Measured: Baseline, week 24

Secondary outcomes (5)

  1. Change from baseline in HbA1c (%) compared to active comparator at week 24

    Change reflects the experimental value (baseline subtract) minus the active comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.

    Measured: Baseline, week 24

  2. The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24

    Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24.

    Measured: Week 24

  3. Change from baseline in HbA1c (%) at week 12, week 40, week 52

    Change reflects the experimental value minus the baseline value at week 12, week 40, week 52. HbA1c represents the percentage of glycosylated hemoglobin.

    Measured: Baseline, week 12, week 40, week 52

  4. The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52

    Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52.

    Measured: Week 12, week 40, week 52

  5. Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24

    Change reflects the experimental value minus the baseline value in the fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24. Plasma glucose was measured on a fasting basis or 2 hours after a standard meal, and is expressed as mmol/L. Body weight is expressed as kg.

    Measured: Baseline, week 12, 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 posted13 Nov 2019
  2. Study start2 Jan 2020
  3. Primary completion27 Jun 2022
  4. Study completion27 Jun 2022

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
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04161430
Sponsor's protocol ID
CSPC/DBPR108201903/PRO-III-1
Status last verified
Sep 2021
First submitted
29 Oct 2019
Last updated
17 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites 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 7 inclusion and 10 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change from baseline in HbA1c (%) compared to placebo comparator at week 24 (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 NCT04161430.

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 17 Aug 2022.

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