Type 2 Diabetes MellitusPhase 4NCT03196362
Impacts of PIO/MET Following Short-term Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes
A Phase 4 study testing Pioglitazone + Metformin in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.
Trial summary
Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to investigate whether sequential treatments using fixed dose combination of pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pioglitazone + Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 31 Dec 2018
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed type 2 diabetes who have never received any hypoglycemic treatment;
- Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl); glycosylated hemoglobin A1C>8.5%;
- Aged between 25 and 65 years,
- Body mass index (BMI) 22-35 kg/m2.
Who cannot join
- Type 1 diabetes or special type of diabetes;
- Acute diabetic complications of diabetes (DKA, HHS and lactic acidosis etc.)
- Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
- Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment;
- Persistently increased blood pressure >180/110 mmHg;
- Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal;
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- Hemoglobin <100 g/L or need regular blood transfusion;
- Use of drugs that may influence blood glucose within 12 weeks;
- Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
- Uncontrolled endocrine gland dysfunction;
- Patients with mental or communication disorders;
- Chronic cardiac insufficiency, heart function class III and above;
- Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
- Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Yanbing Li, MD,PhD, 8602087334331, easd04lyb@126.com
Yanbing Li, MD,PhD
About this study
Official title: Impacts of Sequential Treatment Using Fixed Dose Pioglitazone/Metformin Combination Following Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and β-Cell Function in Patients With Newly Diagnosed Type 2 Diabetes
Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to investigate whether sequential treatments using fixed dose combination of pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with newly diagnosed type 2 diabetes.
We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Patients were randomly assigned into either of the following two groups: PIO/MET group: pioglitazone/metformin (15mg/500mg) will be orally administrated twice daily to the subjects for 12 weeks; placebo group: placebo is given twice daily to all subjects for 12 weeks. Afterwards, patients will be followed up for 48 weeks. Primary endpoint is difference in remission rate at the end of study. Secondary endpoints include proportion of patients who achieve glycosylated hemoglobin A1C <7% at the end of study; differences in β-cell function , insulin sensitivity and incidence of adverse events among treatment groups.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone + Metformin, Placebo Oral Tablet
- Keywords
- short-term intensive insulin therapy, pioglitazone, metformin, remission, sequential therapy
- 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.
Pioglitazone + MetforminDrug
One tablet of fixed dose of Pioglitazone/ Metformin (15mg/30mg) will be given twice daily
Placebo Oral TabletDrug
One tablet of placebo will be given twice daily
| Study group | Role | What they receive |
|---|---|---|
| PIO/MET | Active comparator | one fixed dose pioglitazone/metformin (15mg/500mg) tablet will be orally administrated twice daily Receives: Drug: Pioglitazone + Metformin |
| placebo | Placebo comparator | one tablet of placebo will be given twice daily Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate
Remission rate at the end of the study in each group
Measured: 48 weeks
Secondary outcomes (4)
β-cell function
Difference in β-cell secretion capacity at the end of follow up between treatment groups
Measured: 48 weeks
Insulin sensitivity
Difference in insulin sensitivity at the end of follow up between treatment groups
Measured: 48 weeks
glycemic control
proportion of patients who achieve A1C<7% at the end of follow-up
Measured: 48 weeks
Adverse events
difference in AEs at the end of follow-up between treatment groups
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Dec 2016
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 Sun Yat-sen 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196362
- Sponsor's protocol ID
- 20160145
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Sequential Treatment Using Fixed Dose Pioglitazone/Metformin Combination Following Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and β-Cell Function in Patients With Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03196362
- Acronym / sponsor ID
- 20160145
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- short-term intensive insulin therapy, pioglitazone, metformin, remission, sequential therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 22 Jun 2017 (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.
Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to investigate whether sequential treatments using fixed dose combination of pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with newly diagnosed type 2 diabetes.
We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Patients were randomly assigned into either of the following two groups: PIO/MET group: pioglitazone/metformin (15mg/500mg) will be orally administrated twice daily to the subjects for 12 weeks; placebo group: placebo is given twice daily to all subjects for 12 weeks. Afterwards, patients will be followed up for 48 weeks. Primary endpoint is difference in remission rate at the end of study. Secondary endpoints include proportion of patients who achieve glycosylated hemoglobin A1C <7% at the end of study; differences in β-cell function , insulin sensitivity and incidence of adverse events among treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIO/MET | Active comparator | Drug: Pioglitazone + Metforminone fixed dose pioglitazone/metformin (15mg/500mg) tablet will be orally administrated twice daily |
| placebo | Placebo comparator | Drug: Placebo Oral Tabletone tablet of placebo will be given twice daily |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed type 2 diabetes who have never received any hypoglycemic treatment;
- Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl); glycosylated hemoglobin A1C>8.5%;
- Aged between 25 and 65 years,
- Body mass index (BMI) 22-35 kg/m2.
Key exclusion criteria (14 listed)
- Type 1 diabetes or special type of diabetes;
- Acute diabetic complications of diabetes (DKA, HHS and lactic acidosis etc.)
- Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
- Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment;
- Persistently increased blood pressure >180/110 mmHg;
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 |
|---|---|---|
| Pioglitazone + MetforminOne tablet of fixed dose of Pioglitazone/ Metformin (15mg/30mg) will be given twice daily | Drug | PIO/MET |
| Placebo Oral TabletOne tablet of placebo will be given twice daily | Drug | placebo |
Primary outcome
Remission rate
Time frame: 48 weeks
Remission rate at the end of the study in each group
4 secondary outcomes
β-cell function
Time frame: 48 weeks
Insulin sensitivity
Time frame: 48 weeks
glycemic control
Time frame: 48 weeks
Adverse events
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- 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 4 study testing Pioglitazone + Metformin in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen 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 14 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 22 Jun 2017. 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 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 Liehua Liu, PHD (+8613751748843, turkey310@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate (time frame: 48 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 22 Jun 2017.