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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02338921
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 3
• Actual Duration (Months): 84
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Sitagliptin; Drug: Dapagliflozin; Drug: Lobeglitazone; Drug: Glimepirde; Drug: Metformin	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Nov 30, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glimepirde, Metformin, Sitagliptin Dipeptidyl peptidase-4 (DPP4) inhibitor Sitagliptin	Drug: Sitagliptin; 100mg qd per oral during 24months compared with other treatment groups; Other Names: Januvia ; Drug: Glimepirde; Other Names: Amaryl ; Drug: Metformin
Active Comparator: Glimepirde, Metformin, Dapagliflozin Sodium-glucose cotransporter 2 (SGLT2) inhibitors Dapagliflozin	Drug: Dapagliflozin; 10mg qd per oral during 24months compared with other treatment groups; Other Names: Forxiga ; Drug: Glimepirde; Other Names: Amaryl ; Drug: Metformin
Active Comparator: Glimepirde, Metformin, Lobeglitazone Peroxisome proliferator-activated receptor gamma agonist Lobeglitazone	Drug: Lobeglitazone; 0.5mg qd per oral during 24months compared with other treatment groups; Other Names: Duvie ; Drug: Glimepirde; Other Names: Amaryl ; Drug: Metformin

Outcome Measures

Primary Outcome Measures

1. Glycemic target goal achievement rate [24 months]

   HbA1c< 7.0% without hypoglycemia

Secondary Outcome Measures

1. Beta-cell function [6 and 24 months]

   Beta-cell function

2. insulin resistance [6 and 24 months]

   insulin resistance

3. Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2) [3,6,9,12,16,20 and 24months]

   Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)

4. Lipid profile [3,6,9,12,16,20 and 24months]

   Lipid profile

5. Body fat [6,12 and 24 months]

   Body fat

6. urine microalbumin to creatinine ratio [6,12 and 24 months]

   urine microalbumin to creatinine ratio

7. Change of HbA1c [3,6,9,12,16,20 and 24months]

   Change of HbA1c

8. Glycemic target goal achievement rate [12 months]

   HbA1c< 7.0% without hypoglycemia

Other Outcome Measures

1. hypoglycemia [3,6,9,12,16,20 and 24months]

   hypoglycemia

2. body weight change [6 and 24 months]

   body weight change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soo Lim	Seongnam	Gyeonggi	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

• Principal Investigator: Soo Lim, MD, PHD, SNUBH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT02338921
• Other Study ID Numbers: Triple_3
• First Posted: Jan 14, 2015
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Soo Lim, Professor, Seoul National University Bundang Hospital: triple combination therapy; sitagliptin; dapagliflozin; lobeglitazone
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Metformin; Sitagliptin Phosphate; Dapagliflozin

Study Results

No Results Posted as of Jan 4, 2022