Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study)

NCT02831361 | Completed Phase 3

• 1 other identifier: LG-DPCL016
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or on insulin in combination with metformin stably for 8 weeks.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• changes from baseline HbA1c at week 25

  baseline (Visit 2) and week 25 (visit 6)

Secondary Outcomes (6)

• Responder Rate at week 25

  week 25 (visit 6)

• Changes of HbA1c at each visit

  baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)

• Changes of FPG at each visit

  baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)

• Changes of Fasting serum C-peptide at week 25

  baseline (Visit 2) and week 25 (visit 6)

• Changes of HOMA-IR at week 25

  baseline (Visit 2) and week 25 (visit 6)

Other Outcomes (8)

• Changes of Total Cholesterol at week 25

  baseline (Visit 2) and week 25 (visit 6)

• Changes of cardiovascular disease parameter at week 25

  baseline (Visit 2) and week 25 (visit 6)

• Changes of body weight at each visit

  baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)

Study Arms (2)

Gemigliptin 50mg

EXPERIMENTAL

the subjects should visit a study site at an interval of 6 weeks during the treatment period for 24 weeks in total

Drug: Gemigliptin; Drug: Metformin; Procedure: Diet/exercise questionnaire

Gemigliptin 50mg placebo

PLACEBO COMPARATOR

the subjects should visit a study site at an interval of 6 weeks during the treatment period for 24 weeks in total

Drug: Gemigliptin placebo; Drug: Metformin; Procedure: Diet/exercise questionnaire

Interventions

Gemigliptin DRUG

Gemigliptin 50mg

Gemigliptin placebo DRUG

Gemigliptin 50mg placebo

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

Gemigliptin 50mg; Gemigliptin 50mg placebo

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 regualr 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 -week2, week 1 week 7, week 13, week 19, week 25

Gemigliptin 50mg; Gemigliptin 50mg placebo

Eligibility Criteria

• Age: 19 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 ≥19 years of age at the time of Visit 1 (Screening)
• Patients with HbA1c and FPG values measured at central laboratory satisfying the following conditions at the time of Visit 1(Screening)
• Patients who had not taken OADs other than metformin within 8 weeks prior to Visit 1(Screening) : 7.0% ≤ HbA1c ≤ 11%, FPG \< 270mg/dl
• Patients who had taken OADs other than metformin within 8 weeks prior to Visit 1(Screening) : 6.5% ≤ HbA1c ≤ 10.5%, FPG \< 270mg/dl However, re-test can be carried out only once during the visit window, if the central laboratory values don't meet the criteria mentioned above.
• Patients who had stably received minimum ≥15 U/day and maximum ≤1 U/kg/day of insulin(long-acting, intermediate-acting or pre-mixed) for 8 weeks prior to Visit 1(Screening) ( 'Stably' is defined as the cases in which mean total daily dose of insulin is adjusted to range between ±10% of the dose used on the day of Visit 1(Screening) for 8 weeks prior to Visit 1(Screening).
• For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily without dose adjustment for 8 weeks prior to Visit 1(Screening)
• Patients who are applicable to one of the three in the following.
• Surgically infertile patients
• Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation
• 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
• Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study

You may not qualify if:

• Patients with type 1 diabetes mellitus\*, 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 who had experienced severe hypoglycaemia within 24 weeks prior to Visit 1(Screening) or who had experienced hypoglycaemia at least 3 times a week within 8 weeks prior to Visit 1(Screening)†
• Patients with a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma within 24 weeks prior to Visit 1(Screening) #
• Patients with a history of myocardial infarction, unstable angina, and coronary artery bypass graft(CABG) within 24 weeks prior to Visit 1(Screening)
• 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 4 weeks prior to Visit 1\[Screening\] and whose TSH level is within the normal range can participate in the study.)
• Patients with severe infection or severe trauma at the time of 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 pituitary insufficiency or adrenal insufficiency at the time of Visit 1(Screening)
• 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 who are positive carriers for hepatitis B virus(HBV), hepatitis C virus(HCV), or human immunodeficiency virus(HIV) at the time of Visit 1(Screening) visit
• Patients with a history of alcoholism or drug addiction within 1 year prior to Visit 1(Screening)

Sponsors & Collaborators

• LG Life Sciences: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 13, 2016
• Study Start: October 17, 2016
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share