Type 2 Diabetes MellitusPhase 4NCT00858013
Study of the Durability of Glycemic Control With Nateglinide
A Phase 4 study testing Nateglinide and Glimepiride in people with Type 2 Diabetes Mellitus, run by Ajou University School of Medicine at 7 sites in South Korea.
Trial summary
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Nateglinide and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 24 Apr 2009to 25 Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- age>=18years
- no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy
- metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months)
- 6.5% ≤ HbA1c ≤ 8.5%
- patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
- patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out
Who cannot join
- attending other clinical trials in 3months
- type I diabetes mellitus
- taking systemic steroid in 1month or requiring steroid therapy during clinical trial
- acute myocardial infarction in 6months
- alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
- severe liver disease or AST, ALT ≥ 2.5 x ULN
Show all 10Show fewer
- renal insufficiency (serum creatinine > 2.0mg/dl)
- other severe diabetic complication
- drug hypersensitivity history to nateglinide or sulfonylurea
- pregnant or plan to become pregnant during the clinical trial, lactation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Hanyang University Medical Center
Guri-si, Gyeonggi-do
Myongji Hospital
Ilsan, Kyounggi
Inha University Hospital
Incheon
Hallym University Medical Center
Seoul
Korea University Guro Hospital
Seoul
Kyung hee University Medical Center
Seoul
Ajou University Hospital
Suwon
About this study
Official title: Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.
Read the detailed description
Selected patients will be randomly assigned to receive nateglinide or glimepiride.
Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.
Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is > 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Nateglinide, Glimepiride
- Keywords
- Type 2 Diabetes Mellitus, Nateglinide, Pancreatic beta cell function
- 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.
NateglinideDrug
Also called fastic
Nateglinide 90~120mg three times a day
GlimepirideDrug
Also called amaryl
Glimepiride 1~2mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Nateglinide | Active comparator | Nateglinide 90~120mg three times a day Receives: Drug: Nateglinide |
| Glimepiride | Active comparator | Glimepiride 1~2mg once a day Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)
Measured: every 3 months following randomization, for 24 months
Secondary outcomes (4)
HbA1c
HbA1c (%) at 24 months
Measured: at 24 months
Fasting Glucose
fasting glucose (mg/dL) at 24 months
Measured: at 24 months
C-peptide
c-peptide(uU/mL) at 24 months
Measured: at 24 months
HOMA-IR
insulin resistance marker HOMA-IR at 24 months
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study start24 Apr 2009
- Primary completion25 Jun 2014
- Study completion25 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital, Hanyang University, Inha University Hospital, Kyunghee University Medical Center, Myongji Hospital, Bundang CHA Hospital, Wonju Severance Christian Hospital, Hallym University Medical Center
- Responsible party
- Principal investigator, Kwan Woo Lee, Ajou University School of Medicine
- Investigators
- Kwan Woo Lee, MD,PhD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858013
- Sponsor's protocol ID
- AJIRB-CRO-08-197
- Status last verified
- May 2017
- First submitted
- 6 Mar 2009
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00858013
- Acronym / sponsor ID
- AJIRB-CRO-08-197
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Nateglinide, Pancreatic beta cell function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital, Hanyang University, Inha University Hospital, Kyunghee University Medical Center, Myongji Hospital, Bundang CHA Hospital, Wonju Severance Christian Hospital, Hallym University Medical Center
- Study start
- 24 Apr 2009 (actual)
- Primary completion
- 25 Jun 2014 (actual)
- Study completion
- 25 Jun 2014 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.
Detailed description
Selected patients will be randomly assigned to receive nateglinide or glimepiride.
Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.
Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is > 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nateglinide | Active comparator | Drug: NateglinideNateglinide 90~120mg three times a day |
| Glimepiride | Active comparator | Drug: GlimepirideGlimepiride 1~2mg once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 2 diabetes mellitus
- age>=18years
- no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy
- 6.5% ≤ HbA1c ≤ 8.5%
Key exclusion criteria (10 listed)
- attending other clinical trials in 3months
- type I diabetes mellitus
- taking systemic steroid in 1month or requiring steroid therapy during clinical trial
- acute myocardial infarction in 6months
- alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
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 |
|---|---|---|
| NateglinideAlso: fasticNateglinide 90~120mg three times a day | Drug | Nateglinide |
| GlimepirideAlso: amarylGlimepiride 1~2mg once a day | Drug | Glimepiride |
Primary outcome
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
Time frame: every 3 months following randomization, for 24 months
% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)
4 secondary outcomes
HbA1c
Time frame: at 24 months
Fasting Glucose
Time frame: at 24 months
C-peptide
Time frame: at 24 months
HOMA-IR
Time frame: at 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kwan Woo Lee, MD,PhD principal investigator
Ajou University School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nateglinide and Glimepiride in people with Type 2 Diabetes Mellitus, run by Ajou University School of Medicine at 7 sites 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 7 inclusion and 10 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate (time frame: every 3 months following randomization, for 24 months). 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 16 May 2017.