Soo Lim
Seongnam-si, Gyeonggi-do, 463-707, South Korea
NCT Number: NCT02338921
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.
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Notify Me20 year–80 year
All sexes
Interventional
Phase 4
Seongnam-si, Gyeonggi-do, 463-707, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100mg qd per oral during 24months
compared with other treatment groups
Other names: Januvia
10mg qd per oral during 24months
compared with other treatment groups
Other names: Forxiga
0.5mg qd per oral during 24months
compared with other treatment groups
Other names: Duvie
Other names: Amaryl
Time frame: 24 months
HbA1c< 7.0% without hypoglycemia
Time frame: 6 and 24 months
Beta-cell function
Time frame: 6 and 24 months
insulin resistance
Time frame: 3,6,9,12,16,20 and 24months
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: 6,12 and 24 months
Body fat
Time frame: 6,12 and 24 months
urine microalbumin to creatinine ratio
Time frame: 3,6,9,12,16,20 and 24months
Change of HbA1c
Time frame: 12 months
HbA1c< 7.0% without hypoglycemia
Time frame: 3,6,9,12,16,20 and 24months
hypoglycemia
Time frame: 6 and 24 months
body weight change
Seoul National University Bundang Hospital
Other
Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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