DiabetesPhase 3NCT00461617
Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients
A Phase 3 study testing Mitiglinide in people with Diabetes, run by Kissei Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Mitiglinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jul 2007
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy
Who cannot join
- Type 1 diabetes patients
- Patients who require treatment with insulin
- Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
- Patients with severe ketosis, diabetic coma or precoma
- Patients complicated with severe hepatic diseases
- Patients complicated with severe renal diseases
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- Patients complicated with severe hypertension
- Patients complicated with severe cardiac disease
- Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period
About this study
Official title: Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.
- Conditions
- Diabetes
- Being tested
- Mitiglinide
- Keywords
- diabetes, rapid and short acting insulin secretagogue, α-glucosidase inhibitor, HbA1C, insulin
- Medical subject headings
- Diabetes Mellitus, Fasting, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitiglinideDrug
Also called Glufast
10mg tablet, 10mg TID
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Nateglinide 120 mg TID Receives: Drug: Mitiglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1C)
Measured: -2, 0, 4, 8, 10, 12, 16, 20 week
Secondary outcomes (3)
Fasting plasma glucose level (FPG)
Measured: 0, 4, 8, 12, 16, 20 week
Two-hour postprandial glucose level (PPG2)
Measured: 0, 12, 20 week
One-hour postprandial glucose level (PPG1)
Measured: 0, 12, 20 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startAug 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xin Gao, Professor, Principal investigator, Endocrinology Dept. of Fudan University Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461617
- Sponsor's protocol ID
- KAD1301
- Status last verified
- Apr 2007
- First submitted
- 17 Apr 2007
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00461617
- Acronym / sponsor ID
- KAD1301
- Conditions
- Diabetes
- Keywords
- diabetes, rapid and short acting insulin secretagogue, α-glucosidase inhibitor, HbA1C, insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 18 Apr 2007 (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 purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: MitiglinideNateglinide 120 mg TID |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy
Key exclusion criteria (9 listed)
- Type 1 diabetes patients
- Patients who require treatment with insulin
- Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
- Patients with severe ketosis, diabetic coma or precoma
- Patients complicated with severe hepatic diseases
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 |
|---|---|---|
| MitiglinideAlso: Glufast10mg tablet, 10mg TID | Drug | 2 |
Primary outcome
Hemoglobin A1C (HbA1C)
Time frame: -2, 0, 4, 8, 10, 12, 16, 20 week
3 secondary outcomes
Fasting plasma glucose level (FPG)
Time frame: 0, 4, 8, 12, 16, 20 week
Two-hour postprandial glucose level (PPG2)
Time frame: 0, 12, 20 week
One-hour postprandial glucose level (PPG1)
Time frame: 0, 12, 20 week
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 21 Oct 2008.
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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.
Xin Gao, Professor principal investigator
Endocrinology Dept. of Fudan University Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitiglinide in people with Diabetes, run by Kissei Pharmaceutical Co., Ltd..
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 1 inclusion and 9 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 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Hemoglobin A1C (HbA1C) (time frame: -2, 0, 4, 8, 10, 12, 16, 20 week). 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 21 Oct 2008.