Type 2 Diabetes MellitusPhase 4NCT02426294
Comparison of Pioglitazone Versus Glimepiride in Type 2 Diabetes Inadequately Controlled With Metformin Plus Alogliptin
A Phase 4 study testing Pioglitazone and Glimepiride in people with Type 2 Diabetes Mellitus, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the treatment effect at week 26 between the two groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD, Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pioglitazone and Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to May 2016
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects included in the study are regular type 2 diabetes outpatients of male and female with a level of 7.5%≤HbA1c<10%, despite metformin and alogliptin treatments more than 3months, between 19 and 80 years old.
- Patients had to have a body weight of at least 55 kg and or a body mass index of 22-35 kg/m2
Who cannot join
- the use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
- previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
- the use of insulin within the 3 months prior to screening
- allergy or hypersensitivity to target medication or any of its components
- history of type 1 diabetes; acute metabolic complications of diabetes (e.g. ketoacidosis or hyperosmolar state (coma or precoma)) within the preceding 6 months
- haematological disorders
Show all 27Show fewer
- history of angioedema with angiotensin converting enzyme inhibitors or angiotensin receptor blockers, or treated diabetic gastric paresis
- renal failure, moderate or severe renal impairment (creatinine clearance<50 ㎖/min; or estimated glomerular filtration rate<50 ㎖/min/1.73㎡) before screening
- Serious heart failure or prior history of heart failure(NYHA Class Ⅲ or Ⅳ heart failure.
- impaired hepatic function (defined as elevated serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase 2.5-fold the upper limit of the normal range [ULN] or elevated serum total bilirubin levels 2.5-fold ULN)
- hereditary complications (limited to lactose containing medicines) such as galactose intolerance, deficiency of Lapp lactase, glucose-galactose malabsorption syndrome, etc
- cardiovascular disease, myocardial infarction, or in the previous 6 months; coronary angioplasty, coronary stent placement
- serious cerebrovascular, stroke, transient ischemic attack in the previous 6 months
- laser treatment for proliferative diabetic retinopathy
- history of alcohol or drug abuse in the previous 3 months
- history of all of cancers not in remission for 5 years
- Active bladder cancer
- experience of a major operation
- premenopausal women who were nursing or pregnant were also ineligible for trial participation
- external injury, acute infections, a history/presence of any other severe disease, or severe trauma
- fasting plasma glucose (FPG) level of >239.6mg/dL
- systolic or diastolic blood pressure >160 mmHg or >100 mmHg, respectively
- serum creatinine level of >1.5mg/dL for men or 1.3mg/dL for women
- fasting cholesterol >250mg/dL
- thyroid-stimulating hormone higher than the upper limit of normal
- hemoglobin level is below 12 g/dL for men and below 10 g/dL for women
- fasting triglyceride levels> 5.1 mmol/l (452 mg/dL)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Hospital
Busan, 602-739
Sang Soo Kim, MD., PhD., +82-51-240-7228, drsskim7@gmail.com
Jong Ho Kim, MD., +82-51-240-7983, bedaya@hanmail.net
About this study
Official title: A Phase IV, Multicenter, Randomized, Active Comparator Controlled Study of the Addition of Pioglitazone Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Alogliptin
The purpose of this study is to compare the treatment effect at week 26 between the two groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD, Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin and Alogliptin.
Read the detailed description
- Background Complications of diabetes could cause death from stroke and myocardial infarction, and it is the chronic disease that leads to foot amputation, blindness and renal failure. According to the data of Statistics Korea, the prevalence rate of diabetes for people over 30 years old (standardization) has gradually increased from 8.6% in 2001 to 9.7% in 2010. Although diabetes is not the direct cause of death or disability, it is becoming a significant health problem across the world as it is a major illness causing complications. Diabetic complications are very common; the patients of end-stage renal failure with diabetes were 56.7% and patients who begin renal replacement therapy with diabetes were 70.5% in 2003. The prevalence rate of eye problems including cataract, retinopathies and glaucoma in diabetic patients is 1.9 times higher than that in non-diabetic patients. In addition, it is estimated that the incidence rate of acute stroke, which is a complication of the great vessels of diabetic patients, is also 5.2 times higher than that of the general population. As diabetes could cause various complications and be dangerous, the regulation of blood glucose level is essential in order to prevent these complications. According to the Korea National Health \& Nutrition Examination Survey in 2008~2010, the rate of patients with well-controlled glycated hemoglobin of below 6.5% among diabetic patients over 30 years old is only 25%. Thus, many studies are being conducted to lower the glycated hemoglobin by administering various line drugs, alone or in combination, because the regulation of blood glucose is difficult for many diabetic patients. When the regulation of blood glucose ends in failure with a single dose of a drug, the combination treatment is recommended. Metformin is mainly used as the first-order treatment drug, and the second and third drugs, such as dipeptidyl peptidase-4 (DPP-4) inhibitor and sulphonylurea, are recommended to use if the first one is not sufficient. DPP-4 inhibitor is a new line of hypoglycemic agent based on incretin. It has statistically significant results for the regulation of glycated hemoglobin compared to existing oral hypoglycemic agents. Therefore, many clinicians use Metformin as the first-order drug, and DPP-4 inhibitor as the second-order drug. Alogliptin, which was recently proved to have no side effects of the cardiovascular system, is effective in the regulation of blood glucose as well as the weight control and the prevention of hypoglycemia. Moreover, it is effective when administered alone, and also effective when coadministered with Metformin, Glibenclamide and Pioglitazone. In particular, the reduction degree of glycated hemoglobin was significantly larger when it was administered with Pioglitazone. Sulphonylurea, the most well-known hypoglycemic agent, is helpful in the regulation of blood glucose and reduces the occurrence frequency of hypoglycemia when combined with Metformin.
- Rationale This study examines the related factors of the Pioglitazone group, which is a TZDs line, and the Glimepiride group, which is a sulphonylurea line, as the third-order drugs for patients who are coadministered Metformin and Alogliptin, a DPP-4 inhibitor.
- Hypothesis When the SU and TZDs drugs administered as third-order drugs in the patients who administered second-order drugs, the treatment effect is different between the two drugs
- Primary Aim/Objective: The primary objective is to compare the mean changes of HbA1c at week 26 between the two groups, SU (glimepiride) administration and TZDs (Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin and Alogliptin.
- Primary Endpoint(s):
The mean changes of HbA1c at week 26 from baseline
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone, Glimepiride
- 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.
PioglitazoneDrug
Also called Actos
GlimepirideDrug
Also called Amaryl
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Pioglitazone is a Pioglitazone hydrochloride, and white circle-shaped tablet. It is administered once-daily with 15mg, with or without meals. The once-daily administration begins with 15mg, and if need increase, researchers can increase up to 30mg at week 12. Receives: Drug: Pioglitazone |
| Glimepiride | Active comparator | The generic name of Glimepiride is Glimepiride, and it is a green snowman-shaped tablet. The once-daily administration begins with 2mg, and if need increase, researchers can increase up to 4mg at week 12. Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 26 from baseline
Measured: 26 weeks
Secondary outcomes (3)
Evidence of changes of insulin resistance and secretion at week 26 from baseline
Homeostatic model assessment model
Measured: 26 weeks
Evidence of changes of Lipid profile at week 26 from baseline
LDL (Low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol and triglyceride
Measured: 26 weeks
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 12 from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Ju Kim, Pusan National University Hospital
- Investigators
- In Joo Kim, MD., PhD., Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426294
- Sponsor's protocol ID
- ALO-IIT-013
- Status last verified
- Apr 2015
- First submitted
- 7 Mar 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JM, Kim SS, Kim JH, Kim MK, Kim TN, Lee SH, Lee CW, Park JY, Kim ES, Lee KJ, Choi YS, Kim DK, Kim IJ. Efficacy and Safety of Pioglitazone versus Glimepiride after Metformin and Alogliptin Combination Therapy: A Randomized, Open-Label, Multicenter, Parallel-Controlled Study. Diabetes Metab J. 2020 Feb;44(1):67-77. doi: 10.4093/dmj.2018.0274. Epub 2019 Jul 11.
PubMed 31339011
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Randomized, Active Comparator Controlled Study of the Addition of Pioglitazone Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Alogliptin
- ClinicalTrials.gov ID
- NCT02426294
- Acronym / sponsor ID
- ALO-IIT-013
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- 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 this study is to compare the treatment effect at week 26 between the two groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD, Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin and Alogliptin.
Detailed description
- Background Complications of diabetes could cause death from stroke and myocardial infarction, and it is the chronic disease that leads to foot amputation, blindness and renal failure. According to the data of Statistics Korea, the prevalence rate of diabetes for people over 30 years old (standardization) has gradually increased from 8.6% in 2001 to 9.7% in 2010. Although diabetes is not the direct cause of death or disability, it is becoming a significant health problem across the world as it is a major illness causing complications. Diabetic complications are very common; the patients of end-stage renal failure with diabetes were 56.7% and patients who begin renal replacement therapy with diabetes were 70.5% in 2003. The prevalence rate of eye problems including cataract, retinopathies and glaucoma in diabetic patients is 1.9 times higher than that in non-diabetic patients. In addition, it is estimated that the incidence rate of acute stroke, which is a complication of the great vessels of diabetic patients, is also 5.2 times higher than that of the general population. As diabetes could cause various complications and be dangerous, the regulation of blood glucose level is essential in order to prevent these complications. According to the Korea National Health \& Nutrition Examination Survey in 2008~2010, the rate of patients with well-controlled glycated hemoglobin of below 6.5% among diabetic patients over 30 years old is only 25%. Thus, many studies are being conducted to lower the glycated hemoglobin by administering various line drugs, alone or in combination, because the regulation of blood glucose is difficult for many diabetic patients. When the regulation of blood glucose ends in failure with a single dose of a drug, the combination treatment is recommended. Metformin is mainly used as the first-order treatment drug, and the second and third drugs, such as dipeptidyl peptidase-4 (DPP-4) inhibitor and sulphonylurea, are recommended to use if the first one is not sufficient. DPP-4 inhibitor is a new line of hypoglycemic agent based on incretin. It has statistically significant results for the regulation of glycated hemoglobin compared to existing oral hypoglycemic agents. Therefore, many clinicians use Metformin as the first-order drug, and DPP-4 inhibitor as the second-order drug. Alogliptin, which was recently proved to have no side effects of the cardiovascular system, is effective in the regulation of blood glucose as well as the weight control and the prevention of hypoglycemia. Moreover, it is effective when administered alone, and also effective when coadministered with Metformin, Glibenclamide and Pioglitazone. In particular, the reduction degree of glycated hemoglobin was significantly larger when it was administered with Pioglitazone. Sulphonylurea, the most well-known hypoglycemic agent, is helpful in the regulation of blood glucose and reduces the occurrence frequency of hypoglycemia when combined with Metformin.
- Rationale This study examines the related factors of the Pioglitazone group, which is a TZDs line, and the Glimepiride group, which is a sulphonylurea line, as the third-order drugs for patients who are coadministered Metformin and Alogliptin, a DPP-4 inhibitor.
- Hypothesis When the SU and TZDs drugs administered as third-order drugs in the patients who administered second-order drugs, the treatment effect is different between the two drugs
- Primary Aim/Objective: The primary objective is to compare the mean changes of HbA1c at week 26 between the two groups, SU (glimepiride) administration and TZDs (Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin and Alogliptin.
- Primary Endpoint(s):
The mean changes of HbA1c at week 26 from baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: PioglitazonePioglitazone is a Pioglitazone hydrochloride, and white circle-shaped tablet. It is administered once-daily with 15mg, with or without meals. The once-daily administration begins with 15mg, and if need increase, researchers can increase up to 30mg at week 12. |
| Glimepiride | Active comparator | Drug: GlimepirideThe generic name of Glimepiride is Glimepiride, and it is a green snowman-shaped tablet. The once-daily administration begins with 2mg, and if need increase, researchers can increase up to 4mg at week 12. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects included in the study are regular type 2 diabetes outpatients of male and female with a level of 7.5%≤HbA1c<10%, despite metformin and alogliptin treatments more than 3months, between 19 and 80 years old.
- Patients had to have a body weight of at least 55 kg and or a body mass index of 22-35 kg/m2
Key exclusion criteria (27 listed)
- the use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
- previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
- the use of insulin within the 3 months prior to screening
- allergy or hypersensitivity to target medication or any of its components
- history of type 1 diabetes; acute metabolic complications of diabetes (e.g. ketoacidosis or hyperosmolar state (coma or precoma)) within the preceding 6 months
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 |
|---|---|---|
| PioglitazoneAlso: Actos | Drug | Pioglitazone |
| GlimepirideAlso: Amaryl | Drug | Glimepiride |
Primary outcome
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 26 from baseline
Time frame: 26 weeks
3 secondary outcomes
Evidence of changes of insulin resistance and secretion at week 26 from baseline
Time frame: 26 weeks
Evidence of changes of Lipid profile at week 26 from baseline
Time frame: 26 weeks
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 12 from baseline
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Derived from this study: PubMed 31339011Kim JM, Kim SS, Kim JH, Kim MK, Kim TN, Lee SH, Lee CW, Park JY, Kim ES, Lee KJ, Choi YS, Kim DK, Kim IJ. Efficacy and Safety of Pioglitazone versus Glimepiride after Metformin and Alogliptin Combination Therapy: A Randomized, Open-Label, Multicenter, Parallel-Controlled Study. Diabetes Metab J. 2020 Feb;44(1):67-77. doi: 10.4093/dmj.2018.0274. Epub 2019 Jul 11.
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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.
In Joo Kim, MD., PhD. principal investigator
Pusan National University 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 Pioglitazone and Glimepiride in people with Type 2 Diabetes Mellitus, run by Pusan National University Hospital at 1 site in South Korea.
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 2 inclusion and 27 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 24 Apr 2015. 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 South Korea. 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 Sang Soo Kim, MD., PhD. (+82-51-240-7228, drsskim7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 26 from baseline (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02426294, which also lists 1 linked publication.
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 24 Apr 2015.