Type 2 DiabetesNCT05035849
Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose
A study testing sitagliptin and acarbose in people with Type 2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- sitagliptin and acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2020to 5 May 2021
- Phase
- Interventional
- 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
- Participate voluntarily and sign the subject informed consent before the test.
- Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.
- No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
- Subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Who cannot join
- Patients allergic to insulin.
- Impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- A history of drug abuse and alcohol dependence within the past 5 years.
- Systemic hormone therapy was used in recent 3 months.
- Patients with poor compliance and irregular diet and exercise.
- Patients with infection and stress within four weeks.
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- Patients who cannot tolerate flash glucose mornitoring(FGM).
- Patients who are pregnant, nursing or preparing to become pregnant.
- Any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.
Read the detailed description
In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B after stable glucose control. Flash Glucose Mornitoring(FGM) will be used in patients with two groups. Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. The opposite therapy was true for patients in group B.
- Conditions
- Type 2 Diabetes
- Being tested
- sitagliptin and acarbose
- 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.
sitagliptin and acarboseDrug
One group used first sitagliptin and metformin, then used acarbose and metformin. Another group used first acarbose and metformin, then used sitagliptin andmetformin.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. Receives: Drug: sitagliptin and acarbose |
| Group B | Active comparator | Patients in group B were given acarbose and metformin for the first two weeks, and then were treated with sitagliptin and metformin for the second two weeks.FGM was used to monitor glycemic variations during the whole four weeks. Receives: Drug: sitagliptin and acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variations
CV
Measured: Endpoint at the third month
Secondary outcomes (1)
Glycemic variations
TIR
Measured: Endpoint at the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start30 Jan 2020
- Primary completion30 Apr 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, MD, Study chair, Nanjing First Hospital, Nanjing, Jiangsu, China, 210012
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035849
- Sponsor's protocol ID
- KY20190926-02
- Status last verified
- Aug 2021
- First submitted
- 14 Apr 2021
- Last updated
- 5 Sep 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose
- ClinicalTrials.gov ID
- NCT05035849
- Acronym / sponsor ID
- KY20190926-02
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 5 Sep 2021 (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 aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.
Detailed description
In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B after stable glucose control. Flash Glucose Mornitoring(FGM) will be used in patients with two groups. Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. The opposite therapy was true for patients in group B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: sitagliptin and acarbosePatients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. |
| Group B | Active comparator | Drug: sitagliptin and acarbosePatients in group B were given acarbose and metformin for the first two weeks, and then were treated with sitagliptin and metformin for the second two weeks.FGM was used to monitor glycemic variations during the whole four weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participate voluntarily and sign the subject informed consent before the test.
- Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.
- No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
- Subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Key exclusion criteria (9 listed)
- Patients allergic to insulin.
- Impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- A history of drug abuse and alcohol dependence within the past 5 years.
- Systemic hormone therapy was used in recent 3 months.
- Patients with poor compliance and irregular diet and exercise.
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 |
|---|---|---|
| sitagliptin and acarboseOne group used first sitagliptin and metformin, then used acarbose and metformin. Another group used first acarbose and metformin, then used sitagliptin andmetformin. | Drug | Group A, Group B |
Primary outcome
Glycemic variations
Time frame: Endpoint at the third month
CV
1 secondary outcome
Glycemic variations
Time frame: Endpoint at the third month
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 5 Sep 2021.
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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.
Jianhua Ma, MD study chair
Nanjing First Hospital, Nanjing, Jiangsu, China, 210012
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sitagliptin and acarbose in people with Type 2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University 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 4 inclusion and 9 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 5 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Glycemic variations (time frame: Endpoint at the third month). 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 5 Sep 2021.