Diabetes Mellitus, Type 2Phase 4NCT05386186
The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
A Phase 4 study testing Glimepiride and Sitagliptin in people with Diabetes Mellitus, Type 2 and Severe Insulin Deficient Diabetes, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Severe Insulin Deficient Diabetes
- What is being tested?
- Glimepiride and Sitagliptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Mar 2024
- Phase
- Phase 4
- 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
- According to the World Health Organization (the WHO) 1999 criteria for the diagnosis of type 2 diabetes; the subtype was allocated to severe insulin deficiency diabetes (SIDD) at diagnosis using data-driven diabetes clusters APP.
- Men and women aged ≥ 18 years and ≤ 75 years;
- Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;
- Metformin monotherapy with dosage ≥1500 mg/day for at least 8 weeks;
- Diabetes duration less than 5 years;
- The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c <10.5%
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- estimated estimated glomerular filtration rate (eGFR)>=60 ml/min1.73m2, alanine aminotransferase(ALT)<120U/L ;
- If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;
- Without acute diabetic complications at present.
Who cannot join
- Type 1 diabetes or other special types of diabetes mellitus; glutamic acid decarboxylase antibody (GADA) positive, the subtype was allocated to other subtypes at diagnosis using data-driven diabetes clusters APP.
- Pregnancy or have a pregnancy plan within a year;
- Lactation or have a lactation plan within a year;
- Renal insufficiency, eGFR<60; transaminase elevated, ALT>= 120U/L; unstable coronary heart disease.
- Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;
- Participated in other clinical trials within 8 weeks before randomization; Unable to complete the study follow-up for 6 months; Have situations such as operation and need to change to insulin therapy in 6 months.
- Use concomitant medication such as glucocorticoids which can affect blood sugar.
- The investigator judged that it is not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Please Select, 100044
Xiantong Zou, 88324371, eva2172@163.com
About this study
The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.
Read the detailed description
This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
- Being tested
- Glimepiride, Sitagliptin
- 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.
GlimepirideDrug
Also called SU group (sulphonylurea group)
Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society.
SitagliptinDrug
Also called DPPIVi Group (dipeptidyl peptidase IV inhibitor group)
Add sitagliptin 100mg once daily in all patients randomized to this arm.
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride | Experimental | All participants have background therapy of metformin 1500mg-2000mg, glimepiride1-4mg were added in the patients randomised to this arm considering the baseline HbA1c of the participants. Receives: Drug: Glimepiride |
| Sitagliptin | Active comparator | All participants have background therapy of metformin 1500mg-2000mg, Sitagliptin 100mg were added in the patients randomised to this arm regardless of the baseline HbA1c level in this arm. Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hemoglobin A1c from baseline at the end of the trial.
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
Measured: 26 weeks
Secondary outcomes (4)
Hemoglobin A1c on-target rate
the percentage of A1c<7.0% or A1c<6.5%
Measured: 26 weeks
The difference of self measure blood glucose (SMBG) at every month
The mean of 4-point SMBG for every four weeks
Measured: for 26 weeks
The incidence rate of hypoglycemia
Any measurement of blood glucose<3.9mmol/L or symptoms related to hypoglycemia
Measured: for 26 weeks
The level of weight gain
The difference between body weights at the beginning and end of the trial
Measured: for 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jan 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Jiangsu Province Geriatric Institute
- Responsible party
- Principal investigator, Xiantong Zou, MD. Ph.D., Peking University People's Hospital
- Investigators
- Xiantong Zou, M.D. Ph.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386186
- Sponsor's protocol ID
- zhouxiantong
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
- ClinicalTrials.gov ID
- NCT05386186
- Acronym / sponsor ID
- zhouxiantong
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Jiangsu Province Geriatric Institute
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 23 May 2022 (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 purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.
Detailed description
This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glimepiride | Experimental | Drug: GlimepirideAll participants have background therapy of metformin 1500mg-2000mg, glimepiride1-4mg were added in the patients randomised to this arm considering the baseline HbA1c of the participants. |
| Sitagliptin | Active comparator | Drug: SitagliptinAll participants have background therapy of metformin 1500mg-2000mg, Sitagliptin 100mg were added in the patients randomised to this arm regardless of the baseline HbA1c level in this arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- According to the World Health Organization (the WHO) 1999 criteria for the diagnosis of type 2 diabetes; the subtype was allocated to severe insulin deficiency diabetes (SIDD) at diagnosis using data-driven diabetes clusters APP.
- Men and women aged ≥ 18 years and ≤ 75 years;
- Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;
- Metformin monotherapy with dosage ≥1500 mg/day for at least 8 weeks;
- Diabetes duration less than 5 years;
Key exclusion criteria (8 listed)
- Type 1 diabetes or other special types of diabetes mellitus; glutamic acid decarboxylase antibody (GADA) positive, the subtype was allocated to other subtypes at diagnosis using data-driven diabetes clusters APP.
- Pregnancy or have a pregnancy plan within a year;
- Lactation or have a lactation plan within a year;
- Renal insufficiency, eGFR<60; transaminase elevated, ALT>= 120U/L; unstable coronary heart disease.
- Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;
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 |
|---|---|---|
| GlimepirideAlso: SU group (sulphonylurea group)Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society. | Drug | Glimepiride |
| SitagliptinAlso: DPPIVi Group (dipeptidyl peptidase IV inhibitor group)Add sitagliptin 100mg once daily in all patients randomized to this arm. | Drug | Sitagliptin |
Primary outcome
Reduction of hemoglobin A1c from baseline at the end of the trial.
Time frame: 26 weeks
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
4 secondary outcomes
Hemoglobin A1c on-target rate
Time frame: 26 weeks
The difference of self measure blood glucose (SMBG) at every month
Time frame: for 26 weeks
The incidence rate of hypoglycemia
Time frame: for 26 weeks
The level of weight gain
Time frame: for 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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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.
Xiantong Zou, M.D. Ph.D. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glimepiride and Sitagliptin in people with Diabetes Mellitus, Type 2 and Severe Insulin Deficient Diabetes, run by Peking University People's Hospital 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 May 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiantong Zou, MD.Ph.D. (13370172042, eva2172@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of hemoglobin A1c from baseline at the end of the trial. (time frame: 26 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 23 May 2022.