Type 2 DM Patients With Moderate or Severe Renal ImpairmentPhase 3GUARDNCT01968044
A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)
A Phase 3 study testing Gemigliptin in people with Type 2 DM Patients With Moderate or Severe Renal Impairment, run by LG Life Sciences at 1 site in South Korea.
Trial summary
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks). Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 DM Patients With Moderate or Severe Renal Impairment
- What is being tested?
- Gemigliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Oct 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 Diabetes Mellitus
- Patients with moderate or severe renal insufficiency
- All patients give written informed consent
Who cannot join
- Has type 1 diabetes mellitus or a history of ketoacidosis
- Is on dialysis or is likely to need dialysis during the study
- Has active liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter,Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase IIIb Study to Evaluate the Safety and Efficacy After 12 Weeks Administration of Gemigliptin and Placebo in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment With an Additional 40 Weeks, Double-blind,Active-controlled, Double-dummy,Long-term Extension Study
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).
- Being tested
- Gemigliptin, Placebo to Linagliptin
- Keywords
- renal impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemigliptinDrug
Placebo to LinagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin | Experimental | Participant will remain gemigliptin 50mg throughout entire study (52 weeks). Receives: Drug: Gemigliptin |
| Placebo to linagliptin | Other | Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52. Receives: Drug: Placebo to Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
Measured: HbA1c change from baseline to week 12
Secondary outcomes (9)
HbA1c Change
Measured: HbA1c change from baselint to week 6, 52
FPG
Measured: FPG change from baseline to week 6,12,52
Glycated albumin
Measured: Glycated albumin change from baseline to week 6,12,52
Fructosamin
Measured: Fructosamin change from baseline to week 6,12,52
Waist
Measured: Waist change from baseline to week 12,52
HbA1c responser (HbA1c<7.0%)
Measured: HbA1c responser rate at week 12,52
Fasting serum C-peptide
Measured: Fasting serum C-peptide change from baseline to week 12,52
Fasting Lipid parameters
Measured: Fasting Lipid parameters change from baseline to week 12,52
Albuminuria
Measured: Albuminuria change from baseline to week 12,52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DM Patients With Moderate or Severe Renal ImpairmentStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DR Cha, MD, Ph.D, Principal investigator, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968044
- Sponsor's protocol ID
- LG-DPCL015
- Acronym
- GUARD
- Status last verified
- Mar 2016
- First submitted
- 18 Oct 2013
- Last updated
- 23 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase IIIb Study to Evaluate the Safety and Efficacy After 12 Weeks Administration of Gemigliptin and Placebo in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment With an Additional 40 Weeks, Double-blind,Active-controlled, Double-dummy,Long-term Extension Study
- ClinicalTrials.gov ID
- NCT01968044
- Acronym / sponsor ID
- GUARD / LG-DPCL015
- Keywords
- renal impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Oct 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.
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin | Experimental | Drug: GemigliptinParticipant will remain gemigliptin 50mg throughout entire study (52 weeks). |
| Placebo to linagliptin | Other | Drug: Placebo to LinagliptinParticipant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Type 2 Diabetes Mellitus
- Patients with moderate or severe renal insufficiency
- All patients give written informed consent
Key exclusion criteria (3 listed)
- Has type 1 diabetes mellitus or a history of ketoacidosis
- Is on dialysis or is likely to need dialysis during the study
- Has active liver disease
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 | Drug | Gemigliptin |
| Placebo to Linagliptin | Drug | Placebo to linagliptin |
Primary outcome
HbA1c change
Time frame: HbA1c change from baseline to week 12
9 secondary outcomes
HbA1c Change
Time frame: HbA1c change from baselint to week 6, 52
FPG
Time frame: FPG change from baseline to week 6,12,52
Glycated albumin
Time frame: Glycated albumin change from baseline to week 6,12,52
Fructosamin
Time frame: Fructosamin change from baseline to week 6,12,52
Waist
Time frame: Waist change from baseline to week 12,52
HbA1c responser (HbA1c<7.0%)
Time frame: HbA1c responser rate at week 12,52
Fasting serum C-peptide
Time frame: Fasting serum C-peptide change from baseline to week 12,52
Fasting Lipid parameters
Time frame: Fasting Lipid parameters change from baseline to week 12,52
Albuminuria
Time frame: Albuminuria change from baseline to week 12,52
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 23 Mar 2016.
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.
DR Cha, MD, Ph.D principal investigator
Korea University Ansan Hospital
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 in people with Type 2 DM Patients With Moderate or Severe Renal Impairment, 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 3 inclusion and 3 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 23 Mar 2016. 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 change (time frame: HbA1c change from baseline to week 12). 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 23 Mar 2016.