Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d

This study is currently recruiting participants.
Verified September 2013 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01787396
First received: February 6, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Gemigliptin 50mg
Drug: Placebo(Metformin)
Drug: Metformin
Drug: Placebo(Gemigliptin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d Compared With Either Monotherapy in Treatment naïve Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)


Estimated Enrollment: 429
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm1
Gemigliptin 50mg + Metformin Once daily with dinner
Drug: Gemigliptin 50mg Drug: Metformin
Experimental: Arm 2
Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner
Drug: Gemigliptin 50mg Drug: Placebo(Metformin)
Experimental: Arm3
Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner
Drug: Metformin Drug: Placebo(Gemigliptin)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with type 2 diabetes mellitus
  2. Adults over 20 of age
  3. Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).

    Patients with no previous antidiabetic drugs

  4. Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)

Exclusion Criteria:

  1. Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
  2. Patients with gestational diabetes, or secondary diabetes
  3. Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
  4. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
  5. Patients with active bladder cancer.
  6. Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
  7. Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
  8. Patients with pituitary insufficiency or adrenal dysfunction.
  9. Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
  10. Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
  11. Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
  12. Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
  13. Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
  14. Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), exceeding 2.5 times or bilirubin exceeding 1.5 times of the upper limit of the normal range
  15. Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
  16. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
  17. Patients taking CYP3A4 inducers.(ex, Rifampicin(Rifampin), Dexametha-sone, Phenytoin, Carbamazepine, Rifabutin, Phenobarbital)
  18. Patients taking Furocemide, Nifedipine, Cimetidine
  19. Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)
  20. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit 1.
  21. Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to Visit1(screening), or patients with arrhythmia requiring treatment
  22. Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).
  23. Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
  24. Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.
  25. Patients with history of hypersensitivity to metformin or biguanides.
  26. Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones
  27. Patients who participated in other clinical trial within 3 months prior to Visit1(screening).
  28. Patients with other reasons who the investigator decided not to be eligible for the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01787396

Contacts
Contact: Ji Yung Ahn, BS 82-2-6924-3164 jiyungbori@lgls.com

Locations
Korea, Republic of
LG Life Sciences Recruiting
Seoul, Korea, Republic of, 110-062
Contact: Ji Yung Ahn, BS    82-2-6924-3164    jiyungbori@lgls.com   
Principal Investigator: Jae Myung Yu, MD,PhD         
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01787396     History of Changes
Other Study ID Numbers: LG-DPCL011
Study First Received: February 6, 2013
Last Updated: September 27, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014