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. (see Contacts and Locations)
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

February 6, 2013
September 27, 2013
June 2013
November 2014   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)
Same as current
Complete list of historical versions of study NCT01787396 on ClinicalTrials.gov Archive Site
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Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Gemigliptin 50mg
  • Drug: Placebo(Metformin)
  • Drug: Metformin
  • Drug: Placebo(Gemigliptin)
  • Experimental: Arm1
    Gemigliptin 50mg + Metformin Once daily with dinner
    Interventions:
    • Drug: Gemigliptin 50mg
    • Drug: Metformin
  • Experimental: Arm 2
    Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner
    Interventions:
    • Drug: Gemigliptin 50mg
    • Drug: Placebo(Metformin)
  • Experimental: Arm3
    Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner
    Interventions:
    • Drug: Metformin
    • Drug: Placebo(Gemigliptin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
429
May 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Ji Yung Ahn, BS 82-2-6924-3164 jiyungbori@lgls.com
Korea, Republic of
 
NCT01787396
LG-DPCL011
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LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP