Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy
NCT ID: NCT02338921
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2015-01-31
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Glimepirde, Metformin, Sitagliptin
Dipeptidyl peptidase-4 (DPP4) inhibitor
Sitagliptin
Sitagliptin
100mg qd per oral during 24months
compared with other treatment groups
Glimepirde
Metformin
Glimepirde, Metformin, Dapagliflozin
Sodium-glucose cotransporter 2 (SGLT2) inhibitors
Dapagliflozin
Dapagliflozin
10mg qd per oral during 24months
compared with other treatment groups
Glimepirde
Metformin
Glimepirde, Metformin, Lobeglitazone
Peroxisome proliferator-activated receptor gamma agonist
Lobeglitazone
Lobeglitazone
0.5mg qd per oral during 24months
compared with other treatment groups
Glimepirde
Metformin
Interventions
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Sitagliptin
100mg qd per oral during 24months
compared with other treatment groups
Dapagliflozin
10mg qd per oral during 24months
compared with other treatment groups
Lobeglitazone
0.5mg qd per oral during 24months
compared with other treatment groups
Glimepirde
Metformin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c ≥ 7 %
* combination therapy with glimepiride and metformin over 2 months.
* dosage of glimepiride : 1-8mg/day
* dosage of metformin : 500-2550mg/day
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Soo Lim
Professor
Principal Investigators
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Soo Lim, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
SNUBH
Locations
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Soo Lim
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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Triple_3
Identifier Type: -
Identifier Source: org_study_id
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