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

Type 2 Diabetes Mellitus Clinical Trial

— STABLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890629
• Other study ID #: LG-DPCL012
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2013
• Last updated: March 12, 2015
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Amplitude Glycemic Excursion		Change of MAGE at Week 12 from baseline	No
Secondary	Glucagon		Change of Glucagon at Week 12 from baseline	No
Secondary	Active GLP-1		Change of Active GLP-1 at Week 12 from baseline	No
Secondary	CRP		Change of CRP at Week 12 from baseline	No
Secondary	Nitrotyrosine		Change of nitrotyrosine at Week 12 from baseline	No
Secondary	Glycated albumin		Change of glycated albumin at Week 4 from baseline	No
Secondary	Fructosamine		Change of fructosamine at Week 4 from baseline	No
Secondary	Glucose Standard Deviation in CGMS data		Change of Glucose SD at Week 12 from baseline	No