Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on MAGE in Patients With Type 2 DM

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01890629
First received: May 24, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on MAGE (mean amplitude of glyclemic excursion) in Patients With Type 2 Diabetes Mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on MAGE (Mean Amplitude of Glycemic Excursions) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Mean Amplitude Glycemic Excursion [ Time Frame: Change of MAGE at Week 12 from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucagon [ Time Frame: Change of Glucagon at Week 12 from baseline ] [ Designated as safety issue: No ]
  • Active GLP-1 [ Time Frame: Change of Active GLP-1 at Week 12 from baseline ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: Change of CRP at Week 12 from baseline ] [ Designated as safety issue: No ]
  • Nitrotyrosine [ Time Frame: Change of nitrotyrosine at Week 12 from baseline ] [ Designated as safety issue: No ]
  • Glycated albumin [ Time Frame: Change of glycated albumin at Week 4 from baseline ] [ Designated as safety issue: No ]
  • Fructosamine [ Time Frame: Change of fructosamine at Week 4 from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemigliptin + Metformin
Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks
Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Active Comparator: Sitagliptin + Metformin
Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks
Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Active Comparator: Glimepiride + Metformin
Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks
Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus
  • adults aged ≥ 20 and aged ≤ 70 years old
  • Patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with HbA1c ≥ 7.5%
  • All patients give written informed consent
  • Patients applicable to any one of following 3 categories

    1. Patients with surgically induced infertility
    2. Post-menopause woman ≥45 years of age with over 2 years from the last menstruation
    3. Fertile pre-menopause woman or male patients who has consented for use of two or more contraceptive methods at least up to 14 days after final administration of the investigational product to avoid getting pregnant

Exclusion Criteria:

  • Patients with Type 1 Diabetes, Patients with Diabetic Ketoacidosis or Diabetic Coma as well as Pre-coma
  • Patients with Gestational Diabetes Mellitus or with Secondary Diabetes
  • Patients with NYHA Class III, IV Congestive Heart Failure or with Treatment-requiring Arrhythmia
  • Patients with Thyroid Dysfunction whose TSH is out of normal range, requiring medication therapy
  • Patients with pituitary insufficiency or hypoadrenalism
  • Patients whose BMI is less than 20 Kg/m2 or exceeds 40 Kg/m2
  • Patients whose Total Bilirubin level is 1.5 times higher than the upper limit of normal range and ALT/AST are > 2.5 times higher than the upper limit of normal range
  • Patients currently taking strong CYP3A4 inducers
  • Patients currently taking Warfarin, Dicoumar or Digoxin
  • Patients currently taking any medication from within 4 weeks before Visit 1 (screening) likely to have significant effects on glycemic control or who require to take such medication
  • Patients who had taken anti-obesity drugs within 12 weeks in prior to Visit 1 (screening)
  • Subject who had been treated with Insulin or GLP-1 analogue within 6 months before Visit 1 (screening)
  • Patients who had participated in other clinical study in the past 3 months before Visit 1 (screening)
  • Any other patients whom the investigator considers as inadequate for this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890629

Contacts
Contact: YoungHwan Jang 82-2-6924-3158 younghj@lgls.com

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: BW Lee         
Principal Investigator: BW Lee         
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: SE Park Kangbuk Samsung Medical center
Principal Investigator: BW Lee Severance Hospital
Principal Investigator: JH Jo Seoul St. Mary's Hospital
Principal Investigator: JH Kim Samsung Medical Center
Principal Investigator: JH Jung Asan Medical Center
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01890629     History of Changes
Other Study ID Numbers: LG-DPCL012
Study First Received: May 24, 2013
Last Updated: June 27, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:
diabetes mellitus

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

ClinicalTrials.gov processed this record on October 01, 2014