- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02089126
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes
March 14, 2014 updated by: LG Life Sciences
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride Alone
The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
230
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jong Hee Jin
- Phone Number: 82-2-6924-3122
- Email: jonghee@lgls.com
Study Locations
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Seoul, Korea, Republic of
- The Catholic University of Korea Seoul St. Mary'S Hospital
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Contact:
- Cha
- Email: songppm@cmcnu.or.kr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with type 2 diabetes
- Adults who are at least 19 years old
- Patients who have taken Glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before Visit 1 (screening) as monotherapy or Patients who have taken Glimepiride at a stable dose (≥4mg/day) and Metformin for 8 weeks or more before Visit 1 (screening) as combination therapy
- Patients who satisfy the following HbA1c (%) criteria: 7 ≤ HbA1c ≤ 11
- Patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
Patients who fall under one of the following 3 cases
- Patients who are surgically sterile
- Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
- Fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.
Exclusion Criteria:
- Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
- Patients with gestational diabetes or secondary diabetes
- Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
- Patients with thyroid gland dysfunction and TSH that is out of normal range
- Patients with pituitary insufficiency or adrenal insufficiency
- Patients with hereditary problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Female patients who are pregnant or breastfeeding
- Patients whose BMI exceeds 40 kg/m2
- Patients whose creatinine clearance is below 30mL/min/1.73m2
- Patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose ALT/AST level exceeds 2.5 times the upper limit of the normal range
Patients who are continuously taking the following drugs for 2 weeks or more at Visit 1 (screening), or need to take them continuously and repeatedly
- cyclosporin, sirolimus, tacrolimus, nicotinic acid (≥1500mg/day), isotretinoin
- Strong CYP3A4 inducers: rifampicin (rifampin), phenytoin, carbamazepine, rifabutin, phenobarbital
- warfarin, dicoumarin, digoxin
- systemic glucocorticoids
- Patients who have taken anti-obesity drugs or had a surgery related to obesity within 12 weeks before Visit 1 (screening)
- Patients who have received insulin and GLP-1 analogue treatment within 8 weeks prior to Visit 1 (screening)
- Patients who have received a treatment due to malignant tumor within 5years before Visit 1 (screening) However, patients whose basal cell or squamous cell skin cancer or in situ cervical cancer has been treated can be enrolled.
- Patients with a history of myocardial infarction, unstable angina and coronary artery bypass surgery within 6 months prior to Visit 1 (screening)
- Patients with a history of alcohol or drug addiction within 1 year prior to Visit 1 (screening)
- Patients who have a medical history of hypersensitivity to the same class as Gemigliptin or dipeptidyl peptidase 4 (DPP 4) inhibitor drugs
- Patients with a history of hypersensitivity to the drugs belonging to the same class as Glimepiride or sulfonylureas and sulfonamide
- Patients who have participated in another clinical trial within 3 months prior to Visit 1 (screening)
- Patients deemed unsuitable for this trial based on the judgment of the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemigliptin/Glimepiride combination
Gemigliptin 50mg qd added to ongoing Glimepiride as fix-dose combination.
The subjects will take a total of 2 tablets, Gemigliptin/Glimepiride combination & Placebo for Glimepiride.
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Placebo Comparator: Placebo
The subjects will take a total of 2 tablets, Placebo for Gemigliptin/Glimepiride combination & Glimepiride.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c Changes
Time Frame: Week 0, Week 24
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Week 0, Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
September 1, 2016
Study Registration Dates
First Submitted
March 13, 2014
First Submitted That Met QC Criteria
March 14, 2014
First Posted (Estimate)
March 17, 2014
Study Record Updates
Last Update Posted (Estimate)
March 17, 2014
Last Update Submitted That Met QC Criteria
March 14, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-GGCL001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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