Type 2 Diabetes MellitusPhase 3NCT01787396
Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d
A Phase 3 study testing Gemigliptin 50mg and Metformin in people with Type 2 Diabetes Mellitus, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Gemigliptin 50mg and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 433 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Mar 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus
- Adults over 20 of age
- Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).
- Patients with no previous antidiabetic drugs
- Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)
Who cannot join
- Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- Patients with gestational diabetes, or secondary diabetes
- Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
- Patients with dysfunctional thyroid gland (with abnormal level of TSH)
- Patients with active bladder cancer.
- Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
Show all 28Show fewer
- Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
- Patients with pituitary insufficiency or adrenal dysfunction.
- Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
- Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
- Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
- Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
- Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
- Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), exceeding 2.5 times or bilirubin exceeding 1.5 times of the upper limit of the normal range
- Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
- Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
- Patients taking CYP3A4 inducers.(ex, Rifampicin(Rifampin), Dexametha-sone, Phenytoin, Carbamazepine, Rifabutin, Phenobarbital)
- Patients taking Furocemide, Nifedipine, Cimetidine
- Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)
- Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit 1.
- Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to Visit1(screening), or patients with arrhythmia requiring treatment
- Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).
- Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.
- Patients with history of hypersensitivity to metformin or biguanides.
- Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones
- Patients who participated in other clinical trial within 3 months prior to Visit1(screening).
- Patients with other reasons who the investigator decided not to be eligible for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d Compared With Either Monotherapy in Treatment naïve Patients With Type 2 Diabetes
The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Gemigliptin 50mg, Placebo(Metformin), Metformin, Placebo(Gemigliptin)
- 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.
Gemigliptin 50mgDrug
Placebo(Metformin)Drug
MetforminDrug
Placebo(Gemigliptin)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Gemigliptin 50mg + Metformin Once daily with dinner Receives: Drug: Gemigliptin 50mg; Drug: Metformin |
| Arm 2 | Experimental | Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner Receives: Drug: Gemigliptin 50mg; Drug: Placebo(Metformin) |
| Arm3 | Experimental | Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner Receives: Drug: Metformin; Drug: Placebo(Gemigliptin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787396
- Sponsor's protocol ID
- LG-DPCL011
- Status last verified
- Apr 2015
- First submitted
- 6 Feb 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d Compared With Either Monotherapy in Treatment naïve Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01787396
- Acronym / sponsor ID
- LG-DPCL011
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Gemigliptin 50mg, Drug: MetforminGemigliptin 50mg + Metformin Once daily with dinner |
| Arm 2 | Experimental | Drug: Gemigliptin 50mg, Drug: Placebo(Metformin)Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner |
| Arm3 | Experimental | Drug: Metformin, Drug: Placebo(Gemigliptin)Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type 2 diabetes mellitus
- Adults over 20 of age
- Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).
- Patients with no previous antidiabetic drugs
- Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)
Key exclusion criteria (28 listed)
- Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- Patients with gestational diabetes, or secondary diabetes
- Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
- Patients with dysfunctional thyroid gland (with abnormal level of TSH)
- Patients with active bladder cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemigliptin 50mg | Drug | Arm 2, Arm1 |
| Placebo(Metformin) | Drug | Arm 2 |
| Metformin | Drug | Arm1, Arm3 |
| Placebo(Gemigliptin) | Drug | Arm3 |
Primary outcome
HbA1c
Time frame: 24weeks
Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemigliptin 50mg and Metformin in people with Type 2 Diabetes Mellitus, run by LG Life Sciences at 1 site in South Korea.
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 5 inclusion and 28 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
HbA1c (time frame: 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2015.