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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Amplitude Glycemic Excursion	Change of MAGE at Week 12 from baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Glucagon	Change of Glucagon at Week 12 from baseline
Active GLP-1	Change of Active GLP-1 at Week 12 from baseline
CRP	Change of CRP at Week 12 from baseline
Nitrotyrosine	Change of nitrotyrosine at Week 12 from baseline
Glycated albumin	Change of glycated albumin at Week 4 from baseline
Fructosamine	Change of fructosamine at Week 4 from baseline
Glucose Standard Deviation in CGMS data	Change of Glucose SD at Week 12 from baseline

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Investigators: 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 Jung, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (ESTIMATE): July 2, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2015
• Last Update Submitted That Met QC Criteria: March 12, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate; Glimepiride
• Other Study ID Numbers: LG-DPCL012