Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01890629
First received: May 24, 2013
Last updated: March 12, 2015
Last verified: March 2015

May 24, 2013
March 12, 2015
May 2013
August 2014   (final data collection date for primary outcome measure)
Mean Amplitude Glycemic Excursion [ Time Frame: Change of MAGE at Week 12 from baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01890629 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Glucose Standard Deviation in CGMS data [ Time Frame: Change of Glucose SD at Week 12 from baseline ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)
A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) 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

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
  • Experimental: Gemigliptin + Metformin
    Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks
    Intervention: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
  • Active Comparator: Sitagliptin + Metformin
    Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks
    Intervention: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
  • Active Comparator: Glimepiride + Metformin
    Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks
    Intervention: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01890629
LG-DPCL012
No
LG Life Sciences
LG Life Sciences
Not Provided
Principal Investigator: SE Park Kangbuk Samsung Hospital
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
LG Life Sciences
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP