Clinical trial NCT02338921: Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: triple combination therapy
sitagliptin
dapagliflozin
lobeglitazone
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Glycemic target goal achievement rate
timeFrame: 24 months
Secondary outcomes:
measure: Beta-cell function
timeFrame: 6 and 24 months
measure: insulin resistance
timeFrame: 6 and 24 months
measure: Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)
timeFrame: 3,6,9,12,16,20 and 24months
measure: Lipid profile
timeFrame: 3,6,9,12,16,20 and 24months
measure: Body fat
timeFrame: 6,12 and 24 months
measure: urine microalbumin to creatinine ratio
timeFrame: 6,12 and 24 months
measure: Change of HbA1c
timeFrame: 3,6,9,12,16,20 and 24months
measure: Glycemic target goal achievement rate
timeFrame: 12 months
Other outcomes:
measure: hypoglycemia
timeFrame: 3,6,9,12,16,20 and 24months
measure: body weight change
timeFrame: 6 and 24 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Soo Lim
state: Gyeonggi
Study officials:
affiliation: SNUBH
name: Soo Lim, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: