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Comparison of Pioglitazone Versus Glimepiride in Type 2 Diabetes Inadequately Controlled With Metformin Plus Alogliptin

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ClinicalTrials.gov Identifier: NCT02426294
Recruitment Status : Unknown
Verified April 2015 by In Ju Kim, Pusan National University Hospital.
Recruitment status was:  Recruiting
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
In Ju Kim, Pusan National University Hospital

Brief Summary:
The purpose of this study is to compare the treatment effect at week 26 between the two groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD, Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin and Alogliptin.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Multicenter, Randomized, Active Comparator Controlled Study of the Addition of Pioglitazone Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Alogliptin
Study Start Date : February 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pioglitazone
Pioglitazone is a Pioglitazone hydrochloride, and white circle-shaped tablet. It is administered once-daily with 15mg, with or without meals. The once-daily administration begins with 15mg, and if need increase, researchers can increase up to 30mg at week 12.
Drug: Pioglitazone
Other Name: Actos

Active Comparator: Glimepiride
The generic name of Glimepiride is Glimepiride, and it is a green snowman-shaped tablet. The once-daily administration begins with 2mg, and if need increase, researchers can increase up to 4mg at week 12.
Drug: Glimepiride
Other Name: Amaryl




Primary Outcome Measures :
  1. Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 26 from baseline [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Evidence of changes of insulin resistance and secretion at week 26 from baseline [ Time Frame: 26 weeks ]
    Homeostatic model assessment model

  2. Evidence of changes of Lipid profile at week 26 from baseline [ Time Frame: 26 weeks ]
    LDL (Low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol and triglyceride

  3. Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 12 from baseline [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects included in the study are regular type 2 diabetes outpatients of male and female with a level of 7.5%≤HbA1c<10%, despite metformin and alogliptin treatments more than 3months, between 19 and 80 years old.
  • Patients had to have a body weight of at least 55 kg and or a body mass index of 22-35 kg/m2

Exclusion Criteria:

  • the use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
  • previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
  • the use of insulin within the 3 months prior to screening
  • allergy or hypersensitivity to target medication or any of its components
  • history of type 1 diabetes; acute metabolic complications of diabetes (e.g. ketoacidosis or hyperosmolar state (coma or precoma)) within the preceding 6 months
  • haematological disorders
  • history of angioedema with angiotensin converting enzyme inhibitors or angiotensin receptor blockers, or treated diabetic gastric paresis
  • renal failure, moderate or severe renal impairment (creatinine clearance<50 ㎖/min; or estimated glomerular filtration rate<50 ㎖/min/1.73㎡) before screening
  • Serious heart failure or prior history of heart failure(NYHA Class Ⅲ or Ⅳ heart failure.
  • impaired hepatic function (defined as elevated serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase 2.5-fold the upper limit of the normal range [ULN] or elevated serum total bilirubin levels 2.5-fold ULN)
  • hereditary complications (limited to lactose containing medicines) such as galactose intolerance, deficiency of Lapp lactase, glucose-galactose malabsorption syndrome, etc
  • cardiovascular disease, myocardial infarction, or in the previous 6 months; coronary angioplasty, coronary stent placement
  • serious cerebrovascular, stroke, transient ischemic attack in the previous 6 months
  • laser treatment for proliferative diabetic retinopathy
  • history of alcohol or drug abuse in the previous 3 months
  • history of all of cancers not in remission for 5 years
  • Active bladder cancer
  • experience of a major operation
  • premenopausal women who were nursing or pregnant were also ineligible for trial participation
  • external injury, acute infections, a history/presence of any other severe disease, or severe trauma
  • fasting plasma glucose (FPG) level of >239.6mg/dL
  • systolic or diastolic blood pressure >160 mmHg or >100 mmHg, respectively
  • serum creatinine level of >1.5mg/dL for men or 1.3mg/dL for women
  • fasting cholesterol >250mg/dL
  • thyroid-stimulating hormone higher than the upper limit of normal
  • hemoglobin level is below 12 g/dL for men and below 10 g/dL for women
  • fasting triglyceride levels> 5.1 mmol/l (452 mg/dL)

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): NCT02426294


Contacts
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Contact: Sang Soo Kim, MD., PhD. +82-51-240-7228 drsskim7@gmail.com
Contact: Jo Ho Kim, MD. +82-51-240-7983 bedaya@hanmail.net

Locations
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Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 602-739
Contact: Sang Soo Kim, MD., PhD.    +82-51-240-7228    drsskim7@gmail.com   
Contact: Jong Ho Kim, MD.    +82-51-240-7983    bedaya@hanmail.net   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
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Principal Investigator: In Joo Kim, MD., PhD. Pusan National University Hospital

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Responsible Party: In Ju Kim, Department of Internal Medicine, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02426294     History of Changes
Other Study ID Numbers: ALO-IIT-013
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Pioglitazone
Glimepiride
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action