Comparison of Lobeglitazone With Pioglitazone as Initial Triple Therapy for Diabetes Management

NCT ID: NCT02315287

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2021-12-31

Brief Summary

Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.

Detailed Description

Thiazolidionedione, a PPARgamma agonist, is an strong insulin sensitizer. It has shown that durable glucose lowering effect and beta cell preservation. It is an important treatment option in patients with type 2 diabetes.

It has been well established that inhibition of dipeptidyl peptidase-4 (DPP-4) reduces blood glucose levels in both fasting and postprandial states, and preserves pancreatic β-cell function in patients with type 2 diabetes. The mechanism of action of DPP-4 inhibitors is to increase levels of active incretin, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion as well as insulin biosynthesis while inhibiting glucagon release from pancreatic islets.

DPP4 inhibitors also have better safety and tolerability profiles (e.g., weight neutrality and less hypoglycemia) compared to other hypoglycemic agents. When considering combination therapy with DPP-4 inhibitors, metformin is the most commonly used agent which has been shown to be effective and well tolerated from previous studies. Besides the glucose lowering effect by reducing hepatic glucose output and improving insulin resistance, metformin without inhibiting DPP-4 activity,also increases active GLP-1 concentrations by 1.5- to 2-fold following an oral glucose load in obese, nondiabetic subjects. Accordingly, this effect of metformin may provide a unique benefit when combined with DPP-4 inhibitors through a substantial enhancement of the incretin axis, which provides effective and potentially additive glycemic improvement.

Because of its favorable pharmacological properties, combination of a DPP-4 inhibitor, metformin, and thiazolidinedione has been increasingly used to achieve rapid glycemic goal with low risk of hypoglycemia and no weight gain, and to delay the need for subsequent regimen changes. DPP-4 inhibitors block DPP-4 enzyme and preserve endogenous incretins whereas metformin increases the active form of GLP-1, both of which may enhance the secretory function of pancreas. However, the response to DPP-4 inhibitors and metformin combination therapy may be different in individuals according to their pancreatic function and insulin resistance status. In fact, previous studies with DPP-4 inhibitors showed different potency in glycemic controls depending on various patient characteristics including severity of diabetes and the use of other antidiabetic drug.Consequently, it would be clinically important to investigate effect of this triple combination therapy.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metformin, Sitagliptin, Pioglitazone

Thiazolidinedione

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

Comparison of two different thiazolidinediones

Metformin, Sitagliptin, Lobeglitazone

Thiazolidinedione

Group Type: ACTIVE_COMPARATOR

Lobeglitazone

Intervention Type: DRUG

Comparison of two different thiazolidinediones

Interventions

Pioglitazone

Comparison of two different thiazolidinediones

Intervention Type: DRUG

Lobeglitazone

Comparison of two different thiazolidinediones

Intervention Type: DRUG

Other Intervention Names

Actos; Duvie

Eligibility Criteria

Inclusion Criteria

• HbA1c > 13.0 %
• No treatment with insulin or oral agents for 6 months
• 20 ≤ Age < 80 years

Exclusion Criteria

• Contraindication to sitagliptin or metformin or thiazolidinedione
• Pregnant or breast feeding women
• Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
• Not appropriate for oral antidiabetic agent
• Medication which affect glycemic control
• Disease which affect efficacy and safety of drugs
• Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo Lim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SNUBH

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Soo Lim, MD, PHD

Role: CONTACT

limsoo@snu.ac.kr

82-31-787-7035

Eu Jeong Ku, MD

Role: CONTACT

eujeong.ku@gmail.com

82-31-787-6232

Facility Contacts

Soo Lim, MD, PHD

Role: primary

limsoo@snu.ac.kr

82-31-787-7035

Eu Jeong Ku, MD

Role: backup

eujeong.ku@gmail.com

82-31-787-6232

Other Identifiers

Lobe vs. Pio

Identifier Type: -

Identifier Source: org_study_id