Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy
Information source: Seoul National University Bundang Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Sitagliptin (Drug); Dapagliflozin (Drug); Lobeglitazone (Drug); Glimepirde (Drug); Metformin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Seoul National University Bundang Hospital Official(s) and/or principal investigator(s): Soo Lim, MD, PHD, Principal Investigator, Affiliation: SNUBH
Overall contact: Soo Lim, MD, PHD, Phone: 82-31-787-7035, Email: limsoo@snu.ac.kr
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.
Clinical Details
Official title: Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change of HbA1c
Secondary outcome: Beta-cell functioninsulin resistance Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2) Lipid profile Body fat urine microalbumin to creatinine ratio
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Soo Lim, MD, PHD, Phone: 82-31-787-7035, Email: limsoo@snu.ac.kr
Seoul National University Bundang Hospital, Seongnam, Gyeonggi 463-707, Korea, Republic of
Additional Information
Starting date: January 2015
Last updated: January 13, 2015
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