Type 2 DiabetesPhase 3NCT05629806
Effect of Acarbose and Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes
A Phase 3 study testing Metformin plus pioglitazone and Acarbose in people with Type 2 Diabetes and Blood Glucose Fluctuation, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Blood Glucose Fluctuation
- What is being tested?
- Metformin plus pioglitazone and Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 31 May 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing to participate in this present study;
- Patients with type 2 diabetes receiving stable monotherapy of DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues for more than 3 months;
- Screening glycated hemoglobin (HbA1c) between 7.0% and 10.0%;
- Regular diet and exercise;
- Body mass index (BMI) ≥ 18.5 kg/m2
Who cannot join
- Intolerance of metformin, pioglitazone and acarbose;
- Severe liver disease or elevated transaminases (2.5-fold the upper limit);
- Renal dysfunction or elevated creatinine (1.3-fold the upper limit);
- Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
- Infection or stress state in the past 4 weeks;
- Pregnancy or lactation;
- Patients otherwise adjudged by the investigator to be inappropriate for inclusion into the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical Univesity
Nanjing
Jianhua Ma, Professor
About this study
Official title: Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.
- Conditions
- Type 2 Diabetes, Blood Glucose Fluctuation
- Being tested
- Metformin plus pioglitazone, 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.
Metformin plus pioglitazoneDrug
After the screening period, eligible subjects were admitted to two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. Then the subjects were titrated onto the alternative treatment of 50mg acarbose three times daily for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement.
AcarboseDrug
After the screening period, eligible subjects were admitted to 50mg acarbose three times daily for 12 weeks. Then the subjects were titrated onto the alternative treatment of two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement.
| Study group | Role | What they receive |
|---|---|---|
| Metformin plus pioglitazone | Active comparator | Not described Receives: Drug: Metformin plus pioglitazone; Drug: Acarbose |
| Acarbose | Active comparator | Not described Receives: Drug: Metformin plus pioglitazone; Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose fluctuation
change from baseline blood glucsoe fluctuation at end of study
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start10 Apr 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629806
- Sponsor's protocol ID
- KY20220314-02
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
- ClinicalTrials.gov ID
- NCT05629806
- Acronym / sponsor ID
- KY20220314-02
- Conditions
- Type 2 Diabetes, Blood Glucose Fluctuation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 29 Nov 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.
Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin plus pioglitazone | Active comparator | Drug: Metformin plus pioglitazone, Drug: Acarbose |
| Acarbose | Active comparator | Drug: Metformin plus pioglitazone, Drug: Acarbose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing to participate in this present study;
- Patients with type 2 diabetes receiving stable monotherapy of DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues for more than 3 months;
- Screening glycated hemoglobin (HbA1c) between 7.0% and 10.0%;
- Regular diet and exercise;
- Body mass index (BMI) ≥ 18.5 kg/m2
Key exclusion criteria (7 listed)
- Intolerance of metformin, pioglitazone and acarbose;
- Severe liver disease or elevated transaminases (2.5-fold the upper limit);
- Renal dysfunction or elevated creatinine (1.3-fold the upper limit);
- Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
- Infection or stress state in the past 4 weeks;
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 |
|---|---|---|
| Metformin plus pioglitazoneAfter the screening period, eligible subjects were admitted to two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. Then the subjects were titrated onto the alternative treatment of 50mg acarbose three times daily for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement. | Drug | Acarbose, Metformin plus pioglitazone |
| AcarboseAfter the screening period, eligible subjects were admitted to 50mg acarbose three times daily for 12 weeks. Then the subjects were titrated onto the alternative treatment of two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement. | Drug | Acarbose, Metformin plus pioglitazone |
Primary outcome
Blood glucose fluctuation
Time frame: week 24
change from baseline blood glucsoe fluctuation at end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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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.
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 Metformin plus pioglitazone and Acarbose in people with Type 2 Diabetes and Blood Glucose Fluctuation, 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 5 inclusion and 7 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 29 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Ma, professor (18951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose fluctuation (time frame: week 24). 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 29 Nov 2022.