Type 2 Diabetes MellitusPhase 4STABLENCT01890629
Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)
A Phase 4 study testing Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin in people with Type 2 Diabetes Mellitus, run by LG Life Sciences at 1 site in South Korea.
Trial summary
To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Aug 2014
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 Diabetes Mellitus
- adults aged ≥ 20 and aged ≤ 70 years old
- Patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with HbA1c ≥ 7.5%
- All patients give written informed consent
- Patients applicable to any one of following 3 categories
- Patients with surgically induced infertility
- Post-menopause woman ≥45 years of age with over 2 years from the last menstruation
- Fertile pre-menopause woman or male patients who has consented for use of two or more contraceptive methods at least up to 14 days after final administration of the investigational product to avoid getting pregnant
Who cannot join
- Patients with Type 1 Diabetes, Patients with Diabetic Ketoacidosis or Diabetic Coma as well as Pre-coma
- Patients with Gestational Diabetes Mellitus or with Secondary Diabetes
- Patients with NYHA Class III, IV Congestive Heart Failure or with Treatment-requiring Arrhythmia
- Patients with Thyroid Dysfunction whose TSH is out of normal range, requiring medication therapy
- Patients with pituitary insufficiency or hypoadrenalism
- Patients whose BMI is less than 20 Kg/m2 or exceeds 40 Kg/m2
Show all 14Show fewer
- Patients whose Total Bilirubin level is 1.5 times higher than the upper limit of normal range and ALT/AST are > 2.5 times higher than the upper limit of normal range
- Patients currently taking strong CYP3A4 inducers
- Patients currently taking Warfarin, Dicoumar or Digoxin
- Patients currently taking any medication from within 4 weeks before Visit 1 (screening) likely to have significant effects on glycemic control or who require to take such medication
- Patients who had taken anti-obesity drugs within 12 weeks in prior to Visit 1 (screening)
- Subject who had been treated with Insulin or GLP-1 analogue within 6 months before Visit 1 (screening)
- Patients who had participated in other clinical study in the past 3 months before Visit 1 (screening)
- Any other patients whom the investigator considers as inadequate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes
To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin
- Keywords
- diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin + Metformin | Experimental | Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks Receives: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin |
| Sitagliptin + Metformin | Active comparator | Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks Receives: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin |
| Glimepiride + Metformin | Active comparator | Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks Receives: Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Amplitude Glycemic Excursion
Measured: Change of MAGE at Week 12 from baseline
Secondary outcomes (7)
Glucagon
Measured: Change of Glucagon at Week 12 from baseline
Active GLP-1
Measured: Change of Active GLP-1 at Week 12 from baseline
CRP
Measured: Change of CRP at Week 12 from baseline
Nitrotyrosine
Measured: Change of nitrotyrosine at Week 12 from baseline
Glycated albumin
Measured: Change of glycated albumin at Week 4 from baseline
Fructosamine
Measured: Change of fructosamine at Week 4 from baseline
Glucose Standard Deviation in CGMS data
Measured: Change of Glucose SD at Week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SE Park, Principal investigator, Kangbuk Samsung HospitalBW Lee, Principal investigator, Severance HospitalJH Jo, Principal investigator, Seoul St. Mary's HospitalJH Kim, Principal investigator, Samsung Medical CenterJH Jung, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890629
- Sponsor's protocol ID
- LG-DPCL012
- Acronym
- STABLE
- Status last verified
- Mar 2015
- First submitted
- 24 May 2013
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01890629
- Acronym / sponsor ID
- STABLE / LG-DPCL012
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Jul 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.
To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin + Metformin | Experimental | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + MetforminGemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks |
| Sitagliptin + Metformin | Active comparator | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + MetforminSitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks |
| Glimepiride + Metformin | Active comparator | Drug: Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + MetforminGlimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with Type 2 Diabetes Mellitus
- adults aged ≥ 20 and aged ≤ 70 years old
- Patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with HbA1c ≥ 7.5%
- All patients give written informed consent
- Patients applicable to any one of following 3 categories
Key exclusion criteria (14 listed)
- Patients with Type 1 Diabetes, Patients with Diabetic Ketoacidosis or Diabetic Coma as well as Pre-coma
- Patients with Gestational Diabetes Mellitus or with Secondary Diabetes
- Patients with NYHA Class III, IV Congestive Heart Failure or with Treatment-requiring Arrhythmia
- Patients with Thyroid Dysfunction whose TSH is out of normal range, requiring medication therapy
- Patients with pituitary insufficiency or hypoadrenalism
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 + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin | Drug | Gemigliptin + Metformin, Glimepiride + Metformin, Sitagliptin + Metformin |
Primary outcome
Mean Amplitude Glycemic Excursion
Time frame: Change of MAGE at Week 12 from baseline
7 secondary outcomes
Glucagon
Time frame: Change of Glucagon at Week 12 from baseline
Active GLP-1
Time frame: Change of Active GLP-1 at Week 12 from baseline
CRP
Time frame: Change of CRP at Week 12 from baseline
Nitrotyrosine
Time frame: Change of nitrotyrosine at Week 12 from baseline
Glycated albumin
Time frame: Change of glycated albumin at Week 4 from baseline
Fructosamine
Time frame: Change of fructosamine at Week 4 from baseline
Glucose Standard Deviation in CGMS data
Time frame: Change of Glucose SD at Week 12 from baseline
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 13 Mar 2015.
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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.
SE Park principal investigator
Kangbuk Samsung Hospital
BW Lee principal investigator
Severance Hospital
JH Jo principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + 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 8 inclusion and 14 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 13 Mar 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean Amplitude Glycemic Excursion (time frame: Change of MAGE at Week 12 from baseline). 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 13 Mar 2015.