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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 function

insulin 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

Page last updated: August 23, 2015

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