Type 2 DiabetesPhase 4NCT02315287
Comparison of Lobeglitazone With Pioglitazone as Initial Triple Therapy for Diabetes Management
A Phase 4 study testing Pioglitazone and Lobeglitazone in people with Type 2 Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pioglitazone and Lobeglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to 31 Dec 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c > 13.0 %
- No treatment with insulin or oral agents for 6 months
- 20 ≤ Age < 80 years
Who cannot join
- Contraindication to sitagliptin or metformin or thiazolidinedione
- Pregnant or breast feeding women
- Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
- Not appropriate for oral antidiabetic agent
- Medication which affect glycemic control
- Disease which affect efficacy and safety of drugs
- Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Soo Lim, MD, PHD, 82-31-787-7035, limsoo@snu.ac.kr
Eu Jeong Ku, MD, 82-31-787-6232, eujeong.ku@gmail.com
About this study
Official title: Comparison of Therapeutic Efficacy Between Lobeglitazone and Pioglitazone as Initial Triple Therapy With Metformin and Sitagliptin in Drug-naïve Type 2 Diabetic Patients
Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.
Read the detailed description
Thiazolidionedione, a PPARgamma agonist, is an strong insulin sensitizer. It has shown that durable glucose lowering effect and beta cell preservation. It is an important treatment option in patients with type 2 diabetes.
It has been well established that inhibition of dipeptidyl peptidase-4 (DPP-4) reduces blood glucose levels in both fasting and postprandial states, and preserves pancreatic β-cell function in patients with type 2 diabetes. The mechanism of action of DPP-4 inhibitors is to increase levels of active incretin, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion as well as insulin biosynthesis while inhibiting glucagon release from pancreatic islets.
DPP4 inhibitors also have better safety and tolerability profiles (e.g., weight neutrality and less hypoglycemia) compared to other hypoglycemic agents. When considering combination therapy with DPP-4 inhibitors, metformin is the most commonly used agent which has been shown to be effective and well tolerated from previous studies. Besides the glucose lowering effect by reducing hepatic glucose output and improving insulin resistance, metformin without inhibiting DPP-4 activity,also increases active GLP-1 concentrations by 1.5- to 2-fold following an oral glucose load in obese, nondiabetic subjects. Accordingly, this effect of metformin may provide a unique benefit when combined with DPP-4 inhibitors through a substantial enhancement of the incretin axis, which provides effective and potentially additive glycemic improvement.
Because of its favorable pharmacological properties, combination of a DPP-4 inhibitor, metformin, and thiazolidinedione has been increasingly used to achieve rapid glycemic goal with low risk of hypoglycemia and no weight gain, and to delay the need for subsequent regimen changes. DPP-4 inhibitors block DPP-4 enzyme and preserve endogenous incretins whereas metformin increases the active form of GLP-1, both of which may enhance the secretory function of pancreas. However, the response to DPP-4 inhibitors and metformin combination therapy may be different in individuals according to their pancreatic function and insulin resistance status. In fact, previous studies with DPP-4 inhibitors showed different potency in glycemic controls depending on various patient characteristics including severity of diabetes and the use of other antidiabetic drug.Consequently, it would be clinically important to investigate effect of this triple combination therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- Pioglitazone, Lobeglitazone
- Keywords
- Triple combination, Metformin, Sitagliptin, Pioglitazone, Lobeglitazone
- 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
Comparison of two different thiazolidinediones
LobeglitazoneDrug
Also called Duvie
Comparison of two different thiazolidinediones
| Study group | Role | What they receive |
|---|---|---|
| Metformin, Sitagliptin, Pioglitazone | Active comparator | Thiazolidinedione Receives: Drug: Pioglitazone |
| Metformin, Sitagliptin, Lobeglitazone | Active comparator | Thiazolidinedione Receives: Drug: Lobeglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c
Comparison of therapeutic efficacy of two thiazolidinediones (Piogitazone vs. Lobeglitazone) in drug-naïve Korean type 2 diabetic patients
Measured: 5 and 12 months
Secondary outcomes (6)
Beta-cell function
Changes of beta-cell function after 12 months treatment of triple combination
Measured: 12 months
Insulin resistance
Changes of insulin resistance after 12 months treatment of triple combination
Measured: 12 months
HbA1c < 7.0%
Comparision of glycemic control
Measured: 5 and 12 months
HbA1c =< 6.5%
Comparision of glycemic control
Measured: 5 and 12 months
FBS and PP2
Comparision of glycemic control
Measured: 5 and 12 months
microalbumin to creatinine ratio
Comparision of albumiuria
Measured: 5 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 Seoul National University Bundang 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, PhD, Principal investigator, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315287
- Sponsor's protocol ID
- Lobe vs. Pio
- Status last verified
- Mar 2021
- First submitted
- 11 Sep 2014
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Efficacy Between Lobeglitazone and Pioglitazone as Initial Triple Therapy With Metformin and Sitagliptin in Drug-naïve Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02315287
- Acronym / sponsor ID
- Lobe vs. Pio
- Conditions
- Type 2 Diabetes
- Keywords
- Triple combination, Metformin, Sitagliptin, Pioglitazone, Lobeglitazone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Dec 2014 (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.
Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.
Detailed description
Thiazolidionedione, a PPARgamma agonist, is an strong insulin sensitizer. It has shown that durable glucose lowering effect and beta cell preservation. It is an important treatment option in patients with type 2 diabetes.
It has been well established that inhibition of dipeptidyl peptidase-4 (DPP-4) reduces blood glucose levels in both fasting and postprandial states, and preserves pancreatic β-cell function in patients with type 2 diabetes. The mechanism of action of DPP-4 inhibitors is to increase levels of active incretin, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion as well as insulin biosynthesis while inhibiting glucagon release from pancreatic islets.
DPP4 inhibitors also have better safety and tolerability profiles (e.g., weight neutrality and less hypoglycemia) compared to other hypoglycemic agents. When considering combination therapy with DPP-4 inhibitors, metformin is the most commonly used agent which has been shown to be effective and well tolerated from previous studies. Besides the glucose lowering effect by reducing hepatic glucose output and improving insulin resistance, metformin without inhibiting DPP-4 activity,also increases active GLP-1 concentrations by 1.5- to 2-fold following an oral glucose load in obese, nondiabetic subjects. Accordingly, this effect of metformin may provide a unique benefit when combined with DPP-4 inhibitors through a substantial enhancement of the incretin axis, which provides effective and potentially additive glycemic improvement.
Because of its favorable pharmacological properties, combination of a DPP-4 inhibitor, metformin, and thiazolidinedione has been increasingly used to achieve rapid glycemic goal with low risk of hypoglycemia and no weight gain, and to delay the need for subsequent regimen changes. DPP-4 inhibitors block DPP-4 enzyme and preserve endogenous incretins whereas metformin increases the active form of GLP-1, both of which may enhance the secretory function of pancreas. However, the response to DPP-4 inhibitors and metformin combination therapy may be different in individuals according to their pancreatic function and insulin resistance status. In fact, previous studies with DPP-4 inhibitors showed different potency in glycemic controls depending on various patient characteristics including severity of diabetes and the use of other antidiabetic drug.Consequently, it would be clinically important to investigate effect of this triple combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin, Sitagliptin, Pioglitazone | Active comparator | Drug: PioglitazoneThiazolidinedione |
| Metformin, Sitagliptin, Lobeglitazone | Active comparator | Drug: LobeglitazoneThiazolidinedione |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c > 13.0 %
- No treatment with insulin or oral agents for 6 months
- 20 ≤ Age < 80 years
Key exclusion criteria (7 listed)
- Contraindication to sitagliptin or metformin or thiazolidinedione
- Pregnant or breast feeding women
- Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
- Not appropriate for oral antidiabetic agent
- Medication which affect glycemic control
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: ActosComparison of two different thiazolidinediones | Drug | Metformin, Sitagliptin, Pioglitazone |
| LobeglitazoneAlso: DuvieComparison of two different thiazolidinediones | Drug | Metformin, Sitagliptin, Lobeglitazone |
Primary outcome
Change of HbA1c
Time frame: 5 and 12 months
Comparison of therapeutic efficacy of two thiazolidinediones (Piogitazone vs. Lobeglitazone) in drug-naïve Korean type 2 diabetic patients
6 secondary outcomes
Beta-cell function
Time frame: 12 months
Insulin resistance
Time frame: 12 months
HbA1c < 7.0%
Time frame: 5 and 12 months
HbA1c =< 6.5%
Time frame: 5 and 12 months
FBS and PP2
Time frame: 5 and 12 months
microalbumin to creatinine ratio
Time frame: 5 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
Soo Lim, MD, PhD principal investigator
SNUBH
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 Lobeglitazone in people with Type 2 Diabetes, run by Seoul National University Bundang 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 3 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 30 Mar 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 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 Soo Lim, MD, PHD (82-31-787-7035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c (time frame: 5 and 12 months). 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 30 Mar 2021.