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Trial record 1 of 1 for:    NCT01787396
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01787396
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: 24weeks ]
    Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01787396


Locations
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Korea, Republic of
LG Life Sciences
Seoul, Korea, Republic of, 110-062
Sponsors and Collaborators
LG Life Sciences
More Information
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01787396    
Other Study ID Numbers: LG-DPCL011
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs