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

NCT01890629 | Completed Phase 4

• 1 other identifier: LG-DPCL012
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Mean Amplitude Glycemic Excursion

  Change of MAGE at Week 12 from baseline

Secondary Outcomes (7)

• 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

Study Arms (3)

Gemigliptin + Metformin

EXPERIMENTAL

Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks

Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

Sitagliptin + Metformin

ACTIVE COMPARATOR

Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks

Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

Glimepiride + Metformin

ACTIVE COMPARATOR

Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks

Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

Interventions

Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin DRUG

Gemigliptin + Metformin; Glimepiride + Metformin; Sitagliptin + Metformin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with surgically induced infertility
• Post-menopause woman ≥45 years of age with over 2 years from the last menstruation
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

LC15-0444; Metformin; Sitagliptin Phosphate; glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 2, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 13, 2015

Record last verified: 2015-03

Locations

KR (1)