Type 2 DiabetesPhase 4NCT02338921
Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy
A Phase 4 study testing Sitagliptin, Dapagliflozin and Lobeglitazone in people with Type 2 Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin. 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?
- Sitagliptin, Dapagliflozin and Lobeglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to 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
- 20 ≤ Age < 80 years
- HbA1c ≥ 7 %
- combination therapy with glimepiride and metformin over 2 months.
- dosage of glimepiride : 1-8mg/day
- dosage of metformin : 500-2550mg/day
Who cannot join
- Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
- Contraindication to sitagliptin or dapagliflozin or lobeglitazone
- Pregnant or breast feeding women
- Medication which affect glycemic control (ex. steroid)
- Disease which affect efficacy and safety of drugs
- Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc)
- Not appropriate for oral antidiabetic agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.
To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.
Read the detailed description
Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes.
Recently, various oral hypoglycemic agents were developed including dipeptidyl peptidase (DPP)-IV inhibitor, sodium-glucose cotransporter 2 (SGLT2) inhibitor and new peroxisome proliferator-activated receptors (PPARs) agonists.
But, there have been few studies about the glucose lowering effect of these drugs in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.
Hence, the researchers plan to investigate the efficacy and safety of these drugs in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin, Dapagliflozin, Lobeglitazone, Glimepirde, Metformin
- Keywords
- triple combination therapy, sitagliptin, dapagliflozin, 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.
SitagliptinDrug
Also called Januvia
100mg qd per oral during 24months
compared with other treatment groups
DapagliflozinDrug
Also called Forxiga
10mg qd per oral during 24months
compared with other treatment groups
LobeglitazoneDrug
Also called Duvie
0.5mg qd per oral during 24months
compared with other treatment groups
GlimepirdeDrug
Also called Amaryl
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Glimepirde, Metformin, Sitagliptin | Active comparator | Dipeptidyl peptidase-4 (DPP4) inhibitor
Sitagliptin Receives: Drug: Sitagliptin; Drug: Glimepirde; Drug: Metformin |
| Glimepirde, Metformin, Dapagliflozin | Active comparator | Sodium-glucose cotransporter 2 (SGLT2) inhibitors
Dapagliflozin Receives: Drug: Dapagliflozin; Drug: Glimepirde; Drug: Metformin |
| Glimepirde, Metformin, Lobeglitazone | Active comparator | Peroxisome proliferator-activated receptor gamma agonist
Lobeglitazone Receives: Drug: Lobeglitazone; Drug: Glimepirde; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic target goal achievement rate
HbA1c< 7.0% without hypoglycemia
Measured: 24 months
Secondary outcomes (8)
Beta-cell function
Beta-cell function
Measured: 6 and 24 months
insulin resistance
insulin resistance
Measured: 6 and 24 months
Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)
Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)
Measured: 3,6,9,12,16,20 and 24months
Lipid profile
Lipid profile
Measured: 3,6,9,12,16,20 and 24months
Body fat
Body fat
Measured: 6,12 and 24 months
urine microalbumin to creatinine ratio
urine microalbumin to creatinine ratio
Measured: 6,12 and 24 months
Change of HbA1c
Change of HbA1c
Measured: 3,6,9,12,16,20 and 24months
Glycemic target goal achievement rate
HbA1c< 7.0% without hypoglycemia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion30 Nov 2021
- Study completion31 Dec 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 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
- 78 participants (actual)
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
- NCT02338921
- Sponsor's protocol ID
- Triple_3
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2015
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.
- ClinicalTrials.gov ID
- NCT02338921
- Acronym / sponsor ID
- Triple_3
- Conditions
- Type 2 Diabetes
- Keywords
- triple combination therapy, sitagliptin, dapagliflozin, lobeglitazone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jan 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.
To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.
Detailed description
Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes.
Recently, various oral hypoglycemic agents were developed including dipeptidyl peptidase (DPP)-IV inhibitor, sodium-glucose cotransporter 2 (SGLT2) inhibitor and new peroxisome proliferator-activated receptors (PPARs) agonists.
But, there have been few studies about the glucose lowering effect of these drugs in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.
Hence, the researchers plan to investigate the efficacy and safety of these drugs in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glimepirde, Metformin, Sitagliptin | Active comparator | Drug: Sitagliptin, Drug: Glimepirde, Drug: MetforminDipeptidyl peptidase-4 (DPP4) inhibitor Sitagliptin |
| Glimepirde, Metformin, Dapagliflozin | Active comparator | Drug: Dapagliflozin, Drug: Glimepirde, Drug: MetforminSodium-glucose cotransporter 2 (SGLT2) inhibitors Dapagliflozin |
| Glimepirde, Metformin, Lobeglitazone | Active comparator | Drug: Lobeglitazone, Drug: Glimepirde, Drug: MetforminPeroxisome proliferator-activated receptor gamma agonist Lobeglitazone |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20 ≤ Age < 80 years
- HbA1c ≥ 7 %
- combination therapy with glimepiride and metformin over 2 months.
- dosage of glimepiride : 1-8mg/day
- dosage of metformin : 500-2550mg/day
Key exclusion criteria (7 listed)
- Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
- Contraindication to sitagliptin or dapagliflozin or lobeglitazone
- Pregnant or breast feeding women
- Medication which affect glycemic control (ex. steroid)
- Disease which affect efficacy and safety of drugs
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 |
|---|---|---|
| SitagliptinAlso: Januvia100mg qd per oral during 24months compared with other treatment groups | Drug | Glimepirde, Metformin, Sitagliptin |
| DapagliflozinAlso: Forxiga10mg qd per oral during 24months compared with other treatment groups | Drug | Glimepirde, Metformin, Dapagliflozin |
| LobeglitazoneAlso: Duvie0.5mg qd per oral during 24months compared with other treatment groups | Drug | Glimepirde, Metformin, Lobeglitazone |
| GlimepirdeAlso: Amaryl | Drug | Glimepirde, Metformin, Dapagliflozin, Glimepirde, Metformin, Lobeglitazone, Glimepirde, Metformin, Sitagliptin |
| Metformin | Drug | Glimepirde, Metformin, Dapagliflozin, Glimepirde, Metformin, Lobeglitazone, Glimepirde, Metformin, Sitagliptin |
Primary outcome
Glycemic target goal achievement rate
Time frame: 24 months
HbA1c< 7.0% without hypoglycemia
8 secondary outcomes
Beta-cell function
Time frame: 6 and 24 months
insulin resistance
Time frame: 6 and 24 months
Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)
Time frame: 3,6,9,12,16,20 and 24months
Lipid profile
Time frame: 3,6,9,12,16,20 and 24months
Body fat
Time frame: 6,12 and 24 months
urine microalbumin to creatinine ratio
Time frame: 6,12 and 24 months
Change of HbA1c
Time frame: 3,6,9,12,16,20 and 24months
Glycemic target goal achievement rate
Time frame: 12 months
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 4 Jan 2022.
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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 Sitagliptin, Dapagliflozin 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 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: finished, as of the sponsor's last update on 4 Jan 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 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?
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 target goal achievement rate (time frame: 24 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 4 Jan 2022.