Type 2 Diabetes MellitusPhase 3NCT04218734
A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
A Phase 3 study testing DBPR108, metformin hydrochloride and placepo in people with Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DBPR108, metformin hydrochloride and placepo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2020to 3 Jun 2021
- 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
- Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;
- Age 18-75 years, men and women;
- BMI 19-35 kg/m2;
- HbA1c 7.0%-9.5%;
- Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.
- Signed informed consent from the patient;
- Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.
Who cannot join
- FPG > 13.9 mmol/L;
- Insulin treatment required in the investigator's opinion;
- Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;
- Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
- Severe hypoglycemia;
- Serious diabetic complications (such as diabetic foot, etc.);
Show all 20Show fewer
- History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
- History of being allergic to DPP-4 inhibitors;
- Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;
- Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;
- Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 3*upper limit of normal (ULN), or total bilirubin > 1.5ULN;
- Abnormal renal function;
- White blood cells (WBC) < 3.0109/l, neutrophil count of peripheral blood < 1.5109/l, hemoglobin < 100g / L, triglyceride > 5.7 mmol/l;
- HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;
- Pregnant or lactating women;
- History of alcohol or drug abuse;
- Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;
- Significant unstable diseases;
- Any condition that in the investigator's opinion might render the patient unable to participate the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus
This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DBPR108, metformin hydrochloride, placepo
- Keywords
- DBPR108, Dipeptidyl peptidase-4 (DPP4) inhibitors, metformin hydrochloride
- 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.
DBPR108Drug
DBPR108: 100 mg, once daily for 24 weeks.
metformin hydrochlorideDrug
metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.
placepoDrug
placebo:100 mg, once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| metformin hydrochloride+DBPR108 | Experimental | metformin hydrochloride 500 mg+DBPR108 100 mg Receives: Drug: DBPR108; Drug: metformin hydrochloride |
| metformin hydrochloride+placepo | Placebo comparator | metformin hydrochloride 500 mg+placebo 100 mg Receives: Drug: metformin hydrochloride; Drug: placepo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (%) from baseline to week 24
The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo
Measured: baseline, 24 weeks
Secondary outcomes (6)
Percentage of HbA1c ≤ 6.5%
Proportion of patients achieving HbA1c ≤ 6.5% at week 24
Measured: 24 weeks
Percentage of HbA1c ≤ 7%
Proportion of patients achieving HbA1c ≤ 7% at week 24
Measured: 24 weeks
Change in HbA1c (%) from baseline to week 12
The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo
Measured: baseline, 12 weeks
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24
The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo
Measured: Baseline, 12 weeks and 24 weeks
Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24
The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo
Measured: Baseline, 12 weeks and 24 weeks
Change in body weight from baseline to week 12 and week 24
The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start14 Jan 2020
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kun Lou, Study director, Department of medicine, CSPC clinical development division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218734
- Sponsor's protocol ID
- CSPC/DBPR108201903/PRO-III-2
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2020
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04218734
- Acronym / sponsor ID
- CSPC/DBPR108201903/PRO-III-2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- DBPR108, Dipeptidyl peptidase-4 (DPP4) inhibitors, metformin hydrochloride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 6 Jan 2020 (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.
This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin hydrochloride+DBPR108 | Experimental | Drug: DBPR108, Drug: metformin hydrochloridemetformin hydrochloride 500 mg+DBPR108 100 mg |
| metformin hydrochloride+placepo | Placebo comparator | Drug: metformin hydrochloride, Drug: placepometformin hydrochloride 500 mg+placebo 100 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;
- Age 18-75 years, men and women;
- BMI 19-35 kg/m2;
- HbA1c 7.0%-9.5%;
- Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.
Key exclusion criteria (20 listed)
- FPG > 13.9 mmol/L;
- Insulin treatment required in the investigator's opinion;
- Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;
- Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
- Severe hypoglycemia;
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 |
|---|---|---|
| DBPR108DBPR108: 100 mg, once daily for 24 weeks. | Drug | metformin hydrochloride+DBPR108 |
| metformin hydrochloridemetformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks. | Drug | metformin hydrochloride+DBPR108, metformin hydrochloride+placepo |
| placepoplacebo:100 mg, once daily for 24 weeks. | Drug | metformin hydrochloride+placepo |
Primary outcome
Change in HbA1c (%) from baseline to week 24
Time frame: baseline, 24 weeks
The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo
6 secondary outcomes
Percentage of HbA1c ≤ 6.5%
Time frame: 24 weeks
Percentage of HbA1c ≤ 7%
Time frame: 24 weeks
Change in HbA1c (%) from baseline to week 12
Time frame: baseline, 12 weeks
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24
Time frame: Baseline, 12 weeks and 24 weeks
Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24
Time frame: Baseline, 12 weeks and 24 weeks
Change in body weight from baseline to week 12 and week 24
Time frame: Baseline, 12 weeks and 24 weeks
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 28 Jun 2021.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Kun Lou study director
Department of medicine, CSPC clinical development division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DBPR108, metformin hydrochloride and placepo in people with 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 7 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 28 Jun 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?
Change in HbA1c (%) from baseline to week 24 (time frame: baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2021.