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

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Gemigliptin 50mg
Drug: Placebo(Metformin)
Drug: Metformin
Drug: Placebo(Gemigliptin)
PhasePhase 3
SponsorLG Life Sciences
Responsible PartyLG Life Sciences
ClinicalTrials.gov IdentifierNCT01787396
First ReceivedFebruary 6, 2013
Last UpdatedSeptember 27, 2013
Last verifiedSeptember 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 6, 2013
Last Updated DateSeptember 27, 2013
Start DateJune 2013
Estimated Primary Completion DateMay 2015
Current Primary Outcome MeasuresHbA1c [Time Frame: 24weeks] [Designated as safety issue: No]Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitlePhase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d
Official TitleA 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
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Gemigliptin 50mg
Drug: Placebo(Metformin)
Drug: Metformin
Drug: Placebo(Gemigliptin)
Study Arm (s)
  • Experimental: Arm1
    Gemigliptin 50mg + Metformin Once daily with dinner
  • Experimental: Arm 2
    Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner
  • Experimental: Arm3
    Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment429
Estimated Completion DateMay 2015
Estimated Primary Completion DateNovember 2014
Eligibility 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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsContact: Ji Yung Ahn, BS
82-2-6924-3164
jiyungbori@lgls.com
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01787396
Other Study ID NumbersLG-DPCL011
Has Data Monitoring CommitteeNot Provided
Information Provided ByLG Life Sciences
Study SponsorLG Life Sciences
CollaboratorsNot Provided
Investigators Not Provided
Verification DateSeptember 2013

Locations[ + expand ][ + ]

LG Life Sciences
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
Recruiting