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)

NCT03202563 | Completed Phase 4 DMC

• 1 other identifier: LG-DPCL017
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12

  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)

  baseline (visit 2~visit3) and week 12 (visit 5~visit 6)

Secondary Outcomes (5)

• Changes from baseline MBG(Mean Blood Glucose) at week 12

  baseline (visit 2~visit3) and week 12 (visit 5~visit 6)

• Changes from baseline SD(Standard Deviation) at week 12

  baseline (visit 2~visit3) and week 12 (visit 5~visit 6)

• Changes from baseline CV(Coefficient of variance) at week 12

  baseline (visit 2~visit3) and week 12 (visit 5~visit 6)

• Changes from baseline hsCRP at week 12

  baseline (visit 2) and week 12 (visit 5)

• Changes from baseline Nitrotyrosine at week 12

  baseline (visit 2) and week 12 (visit 5)

Other Outcomes (12)

• Changes of HbA1c at each visit

  baseline(visit 2), week 5(visit 4), week 13(visit 5)

• Changes of Fasting plasma glucose at each visit

  baseline(visit 2), week 5(visit 4), week 13(visit 5)

• Changes of Fasting serum insulin at each visit

  baseline(visit 2), week 5(visit 4), week 13(visit 5)

Study Arms (2)

Gemigliptin 50mg

EXPERIMENTAL

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

Dapagliflozin 10mg

ACTIVE COMPARATOR

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

Interventions

Gemigliptin 50mg DRUG

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))

Gemigliptin 50mg

Dapagliflozin 10mg DRUG

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))

Dapagliflozin 10mg

Diet/exercise questionnaire PROCEDURE

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

Dapagliflozin 10mg; Gemigliptin 50mg

Continuous Glucose Monitoring System(CGMS) DEVICE

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)

Dapagliflozin 10mg; Gemigliptin 50mg

Metformin DRUG

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

Dapagliflozin 10mg; Gemigliptin 50mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes mellitus of 20\~70years of age at the time of Visit 1 (Screening)
• 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)
• Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study
• 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

You may not qualify if:

• Patients with type 1 diabetes mellitus\*, Diabetic ketoacidosis, Diabetic coma, Diabetic pre-coma
• Patients with Gestational diabetes, or secondary diabetes
• Patients with Body Mass Index(BMI) \>40 kg/m2 at the time of Visit 1(Screening)
• 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)

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444; dapagliflozin; Continuous Glucose Monitoring; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jaehyen Kim

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: August 9, 2017
• Primary Completion: July 13, 2018
• Study Completion: December 7, 2018
• Last Updated: February 15, 2019

Record last verified: 2018-05

Locations

KR (1)