Clinical trial NCT01890629: Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean Amplitude Glycemic Excursion
timeFrame: Change of MAGE at Week 12 from baseline
Secondary outcomes:
measure: Glucagon
timeFrame: Change of Glucagon at Week 12 from baseline
measure: Active GLP-1
timeFrame: Change of Active GLP-1 at Week 12 from baseline
measure: CRP
timeFrame: Change of CRP at Week 12 from baseline
measure: Nitrotyrosine
timeFrame: Change of nitrotyrosine at Week 12 from baseline
measure: Glycated albumin
timeFrame: Change of glycated albumin at Week 4 from baseline
measure: Fructosamine
timeFrame: Change of fructosamine at Week 4 from baseline
measure: Glucose Standard Deviation in CGMS data
timeFrame: Change of Glucose SD at Week 12 from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: SE Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: BW Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital
name: JH Jo
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: JH Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: JH Jung
role: PRINCIPAL_INVESTIGATOR
References: