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Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)

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ClinicalTrials.gov Identifier: NCT03202563
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
LG Chem

Brief Summary:
The objective of this study is to evaluate the efficacy on glycemic variability and safety of gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin 10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone or diabetes medication naïve patient

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Gemigliptin 50mg Drug: Dapagliflozin 10mg Procedure: Diet/exercise questionnaire Device: Continuous Glucose Monitoring System(CGMS) Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Phase 4 Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin 50mg q.d., Versus Dapagliflozin 10mg q.d. Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Diabetes Medication Naïve Patient
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : July 13, 2018
Actual Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gemigliptin 50mg

the subjects should visit a study site 4 times during the treatment period for about 12 weeks in total.

Drug: Gemigliptin Drug: Metformin Procedure: Diet/exercise questionnaire Procedure: Continuous Glucose Monitoring System(CGMS)

Drug: Gemigliptin 50mg
For patients who have been randomized to Gemigliptin(Experimental arm), the patients continue to take a gemigliptin 50mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91))

Procedure: Diet/exercise questionnaire

doing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period.

the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91


Device: Continuous Glucose Monitoring System(CGMS)
For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91)

Drug: Metformin
For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study

Active Comparator: Dapagliflozin 10mg

the subjects should visit a study site 4 times during the treatment period for about 12 weeks in total.

Drug: Dapagliflozin Drug: Metformin Procedure: Diet/exercise questionnaire Procedure: Continuous Glucose Monitoring System(CGMS)

Drug: Dapagliflozin 10mg
For patients who have been randomized to Dapagliflozin(Active Comparator arm), the patients continue to take a dapagliflozin 10mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91))

Procedure: Diet/exercise questionnaire

doing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period.

the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91


Device: Continuous Glucose Monitoring System(CGMS)
For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91)

Drug: Metformin
For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study




Primary Outcome Measures :
  1. Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12 [ Time Frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6) ]
    MAGE will be calculated from MBG which has been measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)


Secondary Outcome Measures :
  1. Changes from baseline MBG(Mean Blood Glucose) at week 12 [ Time Frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6) ]
    MBG is a mean blood glucose measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)

  2. Changes from baseline SD(Standard Deviation) at week 12 [ Time Frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6) ]
    SD is a standard deviation of MBG measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)

  3. Changes from baseline CV(Coefficient of variance) at week 12 [ Time Frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6) ]
    CV is a coefficient of variance which is MBG divided by SD measured by MBG during CGM period(visit 2~visit 3, visit 5~visit 6)

  4. Changes from baseline hsCRP at week 12 [ Time Frame: baseline (visit 2) and week 12 (visit 5) ]
  5. Changes from baseline Nitrotyrosine at week 12 [ Time Frame: baseline (visit 2) and week 12 (visit 5) ]

Other Outcome Measures:
  1. Changes of HbA1c at each visit [ Time Frame: baseline(visit 2), week 5(visit 4), week 13(visit 5) ]
    values of parameters at the corresponding visit - values of parameters at visit 2(baseline)

  2. Changes of Fasting plasma glucose at each visit [ Time Frame: baseline(visit 2), week 5(visit 4), week 13(visit 5) ]
    values of parameters at the corresponding visit - values of parameters at visit 2(baseline)

  3. Changes of Fasting serum insulin at each visit [ Time Frame: baseline(visit 2), week 5(visit 4), week 13(visit 5) ]
    values of parameters at the corresponding visit - values of parameters at visit 2(baseline)

  4. Changes of Glycated albumine at each visit [ Time Frame: baseline(visit 2), week 5(visit 4), week 13(visit 5) ]
    values of parameters at the corresponding visit - values of parameters at visit 2(baseline)

  5. Changes of baseline HOMA-β at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  6. Changes of baseline HOMA-IR at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  7. Changes of baseline LDL-C at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  8. Changes of baseline HDL-C at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  9. Changes of baseline Total Cholesterol at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  10. Changes of baselineTriglyceride at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  11. Changes of baseline BMI at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]
  12. Changes of baseline Body weight at week 13 [ Time Frame: baseline(visit 2), week 13(visit 5) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with type 2 diabetes mellitus of 20~70years of age at the time of Visit 1 (Screening)
  2. Patients with HbA1c measured in the local lab ranged from 7 to 11%satisfying the following conditions at the time of Visit 1(Screening)

    • Type 2 diabetes mellitus medication naïve patients or patients who had not taken diabetes medication other than metformin within 8 weeks prior to Visit 1(Screening)
    • For patients who have been taking metformin alone within 12 weeks prior to visit 1(Screening) and had taken at least 1000 mg of metformin daily without dose adjustment for 4 weeks prior to Visit 1(Screening)
  3. Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study
  4. Patients who are applicable to one of the three in the following. 1) Surgically infertile patients 2) Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation 3) Premenopausal fertile female patients or surgically non-infertile male patients who have agreed to use at least 2 kinds of contraceptive measures (certainly including one of the barrier methods) to avoid pregnancy until 14 days after the last dose of the investigational product

    • Barrier methods: Condom, Diaphragm, Cervical cap(Pessary), Spermicide
    • Hormonal methods: Pills, Injection(Depot), Skin patch, Hormonal implant(Implanon), Vaginal ring
    • Intrauterine Devices(IUDs): Cooper IUD(Loop), Hormonal IUD(Mirena)
    • Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinence

Exclusion Criteria:

  1. Patients with type 1 diabetes mellitus*, Diabetic ketoacidosis, Diabetic coma, Diabetic pre-coma
  2. Patients with Gestational diabetes, or secondary diabetes
  3. Patients with Body Mass Index(BMI) >40 kg/m2 at the time of Visit 1(Screening)
  4. Patients with a history of the following

    • Patients with NYHA Class III, IV congestive heart failure or arrhythmia requiring treatment at the time of Visit 1(Screening)
    • Patients whose TSH level is out of the normal range and who have thyroidal dysfunction requiring drug therapy at the time of Visit 1(Screening) (However, those who have been taking thyroid hormone at a fixed dose since previous 6 weeks prior to Visit 1[Screening] and whose TSH level is within the normal range can participate in the study.)
    • Patients with a glomerular filtration rate (eGFR) less than 60 mL/min /1.73 m2, dnd stage renal disease, dialysis or with renal disease that may result from conditions such as cardiovascular shock, acute myocardial infarction and sepsis, or patients with renal insufficiency at the time of Visit 1(Screening)
    • Patients who are receiving intravenous iodine contrast agents at the time of visit 1(Screening) or planned during the clinical trial period (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.) ). For patients who have received this test, they can re-evaluate the renal function 48 hours after the test and only participate in clinical trials after they have been found to be normal.
    • Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at the time of Visit 1(Screening)
    • Patients on drug therapy due to gastrointestinal disturbance including dehydration, diarrhea, and vomiting at the time of Visit 1(Screening) Patients with severe infection or severe trauma at the time of Visit 1(Screening)
    • Patients with malnutrition status, starvation status, weakness status, pituitary insufficiency or adrenal insufficiency at the time of Visit 1(Screening)
    • Patients with a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma within 12 weeks prior to Visit 1(Screening)
    • Patients with a history of myocardial infarction, unstable angina, and coronary artery bypass graft(CABG) within 12 weeks prior to Visit 1(Screening)
    • Patients who had had a surgical operation within 4 weeks prior to Visit 1(Screening) (excluding minor surgeries without restriction on food and fluid intake) or who are scheduled to have a significant surgery during the study period
    • Patients with a history of alcoholism or drug addiction within 12weaks prior to Visit 1(Screening)
    • Patients with a history of malignant tumors within 5 years prior to Visit 1(Screening). However, patients with basal cell or squamous cell skin cancer, or in situ cervical cancer treated properly can participate in the study.
  5. Patients with the outcomes of the laboratory tests performed at Visit 1(Screening) applicable to the criteria below

    • Bilirubin >2 × upper limit of normal(ULN)
    • AST/ALT >3 × ULN
  6. Patients with a history of hypersensitivity reactions to the drugs below

    • Gemigliptin or drugs belonging to dipeptidyl-peptidase4(DPP4) inhibitors
    • Dapagliflozin or drugs belonging to Sodium/glucose co transport-2(SGLT-2) inhibitor
    • Metformin or drugs belonging to biguanides
  7. Patients who were administered the drugs below

    • Patients who had been administered anti-obesity drugs within 4 weeks prior to Visit 1(Screening)
    • Patients who had been administered insulin or GLP-1 analogues within 8 weeks prior to Visit 1(Screening)
    • Patients who had been administered warfarin, dicoumarin, and digoxin within 4 weeks prior to Visit 1(Screening)
    • Patients who are being administered any of the strong CYP3A4 inducers (rifampicin[rifampin], dexamethasone, phenytoin, carbamazepine, rifabutin, phenobarbital) at the time of Visit 1(Screening)
    • Patients who had been being administered glucocorticoids continuously within 2 weeks prior to Visit 1(Screening) or who are required to take glucocorticoids continuously in the future
  8. Patients with a genetic problems such as Galactose intolerance, Lapp lactose deficiency, Glucose-galactose malabsorption)
  9. Female patients who are pregnant or lactating
  10. Patients who have an experience of participation in another clinical study within 12 weeks prior to Visit1(screening)
  11. Patients who are otherwise considered to be ineligible for this study on investigators' judgment

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): NCT03202563


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
LG Chem
Investigators
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Principal Investigator: Jaehyen Kim Samsung Medical Center

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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03202563     History of Changes
Other Study ID Numbers: LG-DPCL017
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action