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Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02089126
Recruitment Status : Unknown
Verified March 2014 by LG Life Sciences.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Study Description
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Brief Summary:
The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Gemigliptin/Glimepiride combination Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride Alone
Study Start Date : June 2014
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gemigliptin/Glimepiride combination
Gemigliptin 50mg qd added to ongoing Glimepiride as fix-dose combination. The subjects will take a total of 2 tablets, Gemigliptin/Glimepiride combination & Placebo for Glimepiride.
 Drug: Gemigliptin/Glimepiride combination
Placebo Comparator: Placebo
The subjects will take a total of 2 tablets, Placebo for Gemigliptin/Glimepiride combination & Glimepiride.


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c Changes [ Time Frame: Week 0, Week 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with type 2 diabetes
  2. Adults who are at least 19 years old
  3. Patients who have taken Glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before Visit 1 (screening) as monotherapy or Patients who have taken Glimepiride at a stable dose (≥4mg/day) and Metformin for 8 weeks or more before Visit 1 (screening) as combination therapy
  4. Patients who satisfy the following HbA1c (%) criteria: 7 ≤ HbA1c ≤ 11
  5. Patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative

  6. Patients who fall under one of the following 3 cases

    1. Patients who are surgically sterile
    2. Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
    3. Fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.

Exclusion Criteria:

  1. Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
  2. Patients with gestational diabetes or secondary diabetes
  3. Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
  4. Patients with thyroid gland dysfunction and TSH that is out of normal range
  5. Patients with pituitary insufficiency or adrenal insufficiency
  6. Patients with hereditary problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  7. Female patients who are pregnant or breastfeeding
  8. Patients whose BMI exceeds 40 kg/m2
  9. Patients whose creatinine clearance is below 30mL/min/1.73m2
  10. Patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose ALT/AST level exceeds 2.5 times the upper limit of the normal range

  11. Patients who are continuously taking the following drugs for 2 weeks or more at Visit 1 (screening), or need to take them continuously and repeatedly

    • cyclosporin, sirolimus, tacrolimus, nicotinic acid (≥1500mg/day), isotretinoin
    • Strong CYP3A4 inducers: rifampicin (rifampin), phenytoin, carbamazepine, rifabutin, phenobarbital
    • warfarin, dicoumarin, digoxin
    • systemic glucocorticoids
  12. Patients who have taken anti-obesity drugs or had a surgery related to obesity within 12 weeks before Visit 1 (screening)
  13. Patients who have received insulin and GLP-1 analogue treatment within 8 weeks prior to Visit 1 (screening)
  14. Patients who have received a treatment due to malignant tumor within 5years before Visit 1 (screening) However, patients whose basal cell or squamous cell skin cancer or in situ cervical cancer has been treated can be enrolled.
  15. Patients with a history of myocardial infarction, unstable angina and coronary artery bypass surgery within 6 months prior to Visit 1 (screening)
  16. Patients with a history of alcohol or drug addiction within 1 year prior to Visit 1 (screening)
  17. Patients who have a medical history of hypersensitivity to the same class as Gemigliptin or dipeptidyl peptidase 4 (DPP 4) inhibitor drugs
  18. Patients with a history of hypersensitivity to the drugs belonging to the same class as Glimepiride or sulfonylureas and sulfonamide
  19. Patients who have participated in another clinical trial within 3 months prior to Visit 1 (screening)
  20. Patients deemed unsuitable for this trial based on the judgment of the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089126


Contacts
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Contact: Jong Hee Jin 82-2-6924-3122 jonghee@lgls.com

Locations
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Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Contact: Cha       songppm@cmcnu.or.kr   
Sponsors and Collaborators
LG Life Sciences
More Information
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02089126    
Other Study ID Numbers: LG-GGCL001
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
 Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors