Overview
Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d
Status:
Completed
Completed
Trial end date:
2015-03-01
2015-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
LG Life SciencesTreatments:
Metformin
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