AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3NCT02831361

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)

A Phase 3 study testing Gemigliptin, Metformin and Diet/exercise questionnaire in people with Type 2 Diabetes Mellitus, run by LG Life Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Gemigliptin, Metformin and Diet/exercise questionnaire
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
No sites listed yet
Study dates
17 Oct 2016to 8 Feb 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 18Show fewer
  • 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
  • For patients who have gone through the washout period, the inclusion criteria below should be checked at Visit 1-1(Screening).
  • Patients whose HbA1c and FPG measured at Visit 1-1(Screening) are 7.0%~11% and <270 mg/dl, respectively
  • Patients whose mean daily dose of insulin checked at Visit 1-1(Screening) ranges between ±10% of the dose checked at Visit 1(Screening)

Who cannot join

  • 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)
Show all 38Show fewer
  • 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)
  • 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.
  • Patients with end-stage renal disease(ESRD) at the time of Visit 1(Screening)
  • Patients with the outcomes of the laboratory tests performed at Visit 1(Screening) applicable to the criteria below
  • Bilirubin >1.5 × upper limit of normal(ULN)
  • AST/ALT >2.5 × ULN
  • Male and female patients on metformin and with serum creatinine level of ≥1.5 mg/dl and ≥1.4 mg/dl, respectively at the time of Visit 1(Screening)
  • Patients with a history of hypersensitivity reactions to the drugs below
  • Gemigliptin or drugs belonging to dipeptidyl-peptidase4(DPP4) inhibitors
  • Metformin or drugs belonging to biguanides
  • Insulin
  • Patients who were administered the drugs below
  • Patients who had been administered anti-obesity drugs within 12 weeks prior to Visit 1(Screening)
  • Patients who had been administered short-acting or rapid-acting insulin before meals within 8 weeks prior to Visit 1(Screening)
  • Patients who had been administered 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 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
  • 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 are being administered cimetidine at the time of Visit 1(Screening)
  • Female patients who are pregnant or lactating
  • Patients who have an experience of participation in another clinical study within 12 weeks prior to Visit1(screening)
  • Patients who are otherwise considered to be ineligible for this study on investigators' judgment For patients who have gone through the washout period, the exclusion criteria below should be checked at Visit 1-1(Screening).
  • Patients whose mean daily dose of insulin during the 8-week washout period which has been beyond ±10% of the dose checked at Visit 1(Screening) for ≥ 12 days or for 5 consecutive days
  • At Visit 1(Screening) or Visit 1-1(Screening), subjects who meet the inclusion/exclusion criteria can enter the 2-week run-in period along with exercise/diet.

About this study

Official title: A Multinational, Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Gemigliptin 50 mg q.d Compared With Placebo Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

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.

Being tested
Gemigliptin, Gemigliptin placebo, Metformin, Diet/exercise questionnaire
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemigliptinDrug

  • Gemigliptin placeboDrug

  • MetforminDrug

    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

  • Diet/exercise questionnaireProcedure or surgery

    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

Study groups in NCT02831361
Study groupRoleWhat they receive
Gemigliptin 50mgExperimentalthe subjects should visit a study site at an interval of 6 weeks during the treatment period for 24 weeks in total
Receives: Drug: Gemigliptin; Drug: Metformin; Procedure: Diet/exercise questionnaire
Gemigliptin 50mg placeboPlacebo comparatorthe subjects should visit a study site at an interval of 6 weeks during the treatment period for 24 weeks in total
Receives: Drug: Gemigliptin placebo; Drug: Metformin; Procedure: Diet/exercise questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes from baseline HbA1c at week 25

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

Secondary outcomes (6)

  1. Responder Rate at week 25

    HbA1c <7% , HbA1c <6.5%

    Measured: week 25 (visit 6)

  2. Changes of HbA1c at each visit

    values of parameters at the corresponding visit - values of parameters at visit 2(baseline)

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

  3. Changes of FPG at each visit

    values of parameters at the corresponding visit - values of parameters at visit 2(baseline)

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

  4. Changes of Fasting serum C-peptide at week 25

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

  5. Changes of HOMA-IR at week 25

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

  6. Changes of HOMA-β at week 25

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study start17 Oct 2016
  3. Primary completion8 Feb 2018
  4. Study completion8 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831361
Sponsor's protocol ID
LG-DPCL016
Status last verified
Feb 2018
First submitted
23 Jun 2016
Last updated
22 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemigliptin, Metformin and Diet/exercise questionnaire in people with Type 2 Diabetes Mellitus, run by LG Life Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes from baseline HbA1c at week 25 (time frame: baseline (Visit 2) and week 25 (visit 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in