Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

Type 2 Diabetes Clinical Trial

Official title:

Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338921
• Other study ID #: Triple_3
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Soo Lim	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hypoglycemia	hypoglycemia	3,6,9,12,16,20 and 24months
Other	body weight change	body weight change	6 and 24 months
Primary	Glycemic target goal achievement rate	HbA1c< 7.0% without hypoglycemia	24 months
Secondary	Beta-cell function	Beta-cell function	6 and 24 months
Secondary	insulin resistance	insulin resistance	6 and 24 months
Secondary	Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)	Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)	3,6,9,12,16,20 and 24months
Secondary	Lipid profile	Lipid profile	3,6,9,12,16,20 and 24months
Secondary	Body fat	Body fat	6,12 and 24 months
Secondary	urine microalbumin to creatinine ratio	urine microalbumin to creatinine ratio	6,12 and 24 months
Secondary	Change of HbA1c	Change of HbA1c	3,6,9,12,16,20 and 24months
Secondary	Glycemic target goal achievement rate	HbA1c< 7.0% without hypoglycemia	12 months