Skip to main content
OpenTrials
Completed

NCT Number: NCT01890629

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

Drug

Primary outcomes

  1. Mean Amplitude Glycemic Excursion

    Time frame: Change of MAGE at Week 12 from baseline

Secondary outcomes

  1. Glucagon

    Time frame: Change of Glucagon at Week 12 from baseline

  2. Active GLP-1

    Time frame: Change of Active GLP-1 at Week 12 from baseline

  3. CRP

    Time frame: Change of CRP at Week 12 from baseline

  4. Nitrotyrosine

    Time frame: Change of nitrotyrosine at Week 12 from baseline

  5. Glycated albumin

    Time frame: Change of glycated albumin at Week 4 from baseline

  6. Fructosamine

    Time frame: Change of fructosamine at Week 4 from baseline

  7. Glucose Standard Deviation in CGMS data

    Time frame: Change of Glucose SD at Week 12 from baseline

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Acronym: STABLE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2013
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.