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

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ClinicalTrials.gov Identifier: NCT02315287
Recruitment Status : Recruiting
First Posted : December 11, 2014
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Pioglitazone Drug: Lobeglitazone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Efficacy Between Lobeglitazone and Pioglitazone as Initial Triple Therapy With Metformin and Sitagliptin in Drug-naïve Type 2 Diabetic Patients
Actual Study Start Date : September 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metformin, Sitagliptin, Pioglitazone
Thiazolidinedione
Drug: Pioglitazone
Comparison of two different thiazolidinediones
Other Name: Actos

Active Comparator: Metformin, Sitagliptin, Lobeglitazone
Thiazolidinedione
Drug: Lobeglitazone
Comparison of two different thiazolidinediones
Other Name: Duvie




Primary Outcome Measures :
  1. Change of HbA1c [ Time Frame: 5 and 12 months ]
    Comparison of therapeutic efficacy of two thiazolidinediones (Piogitazone vs. Lobeglitazone) in drug-naïve Korean type 2 diabetic patients


Secondary Outcome Measures :
  1. Beta-cell function [ Time Frame: 12 months ]
    Changes of beta-cell function after 12 months treatment of triple combination

  2. Insulin resistance [ Time Frame: 12 months ]
    Changes of insulin resistance after 12 months treatment of triple combination

  3. HbA1c < 7.0% [ Time Frame: 5 and 12 months ]
    Comparision of glycemic control

  4. HbA1c =< 6.5% [ Time Frame: 5 and 12 months ]
    Comparision of glycemic control

  5. FBS and PP2 [ Time Frame: 5 and 12 months ]
    Comparision of glycemic control

  6. microalbumin to creatinine ratio [ Time Frame: 5 and 12 months ]
    Comparision of albumiuria


Other Outcome Measures:
  1. Hypoglycemia [ Time Frame: 12 months ]
    Incidence of hypoglycemia in triple combination treatment

  2. Body weight [ Time Frame: 12 months ]
    Changes of weight after 12months treatment of triple combination



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315287


Contacts
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Contact: Soo Lim, MD, PHD 82-31-787-7035 limsoo@snu.ac.kr
Contact: Eu Jeong Ku, MD 82-31-787-6232 eujeong.ku@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Soo Lim, MD, PHD    82-31-787-7035    limsoo@snu.ac.kr   
Contact: Eu Jeong Ku, MD    82-31-787-6232    eujeong.ku@gmail.com   
Principal Investigator: Soo Lim, MD, PHD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Soo Lim, MD, PhD SNUBH

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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02315287     History of Changes
Other Study ID Numbers: Lobe vs. Pio
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
Triple combination
Metformin
Sitagliptin
Pioglitazone
Lobeglitazone

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Pioglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action