Type 2 Diabetes MellitusPhase 4Match-101NCT02143765
Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Mitiglinide and Acarbose in people with Type 2 Diabetes Mellitus, run by Zhongda Hospital at 6 sites in China.
Trial summary
Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Mitiglinide and Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 6 sitesChina
- Study dates
- May 2014to Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 and 70, regardless of gender
- Subjects with type-2 diabetes mellitus diagnosed according to 1999 WHO criteria within 5 years
- Subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors
- Subjects whose fasting blood glucose [FBG] between7.0 and10.0 mmol/L and HbA1c ratio is between 7.0% and 10.0%
- Note: Incretin mimetics contain glucagon-like peptide 1 (GLP-1) receptor agonist (including GLP-1 analogues) and dipeptidyl peptidase 4 inhibitors.
Who cannot join
- Subjects with abnormal hepatic function whose aspartate transaminase (AST) and alanine transaminase (ALT) are 2 times higher than the upper limits of normal (ULN)
- Subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 ULN or positive urine protein
- Subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease
- Subjects who have chronic intestinal diseases associated with marked disorders of digestion or absorption and may deteriorate as a result of increased gas formation in the intestine (like Gastrocardiac Syndrome, severe hernia, intestinal obstruction, intestinal ulcer and intestinal surgery)
- Subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc.
- Subject is contraindicated or hypersensitivity to both experimental drugs or comparator drugs
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- Subjects who participated in other clinical studies as subjects within 3 months before this study
- Female subjects who have been pregnant , lactating or without contraception in childbearing potential
- Subjects judged unfit for this study by investigators
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The First People's Hospital of Changzhou
Changzhou, Jiangsu
The Second People's Hospital of Huai'an
Huai'an, Jiangsu
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu
Yancheng City No.1 People's Hospital
Yancheng, Jiangsu
Zhenjiang First People's Hospital
Zhenjiang, Jiangsu
About this study
Official title: An Open, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Mitiglinide Versus Acarbose in Patients With Type 2 Diabetes Mellitus in China
Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control.
This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in patients with type 2 diabetes mellitus.
Read the detailed description
Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248, randomized to 2 groups at ratio of 1:1.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Mitiglinide, Acarbose
- Keywords
- Mitiglinide, Acarbose, Type 2 Diabetes Mellitus
- 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.
MitiglinideDrug
Also called FADI
three times a day, orally, for 12 weeks
AcarboseDrug
Also called PRECOSE
three times a day, orally, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mitiglinide | Experimental | Mitiglinide 10 mg three times a day, orally, for 12 weeks Receives: Drug: Mitiglinide |
| Acarbose | Active comparator | Acarbose 50 mg three times a day, orally, for 12 weeks Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Measured: Baseline and Week 12
Secondary outcomes (5)
the change from baseline to the end of treatment in fasting blood glucose (FBG), postprandial blood glucose (PBG)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Number of Participants with Serious and Non-Serious Adverse Events
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: up to 12 weeks
the change from baseline to the end of treatment in Diabetes Quality of Life
measured by Diabetes specific Quality of Life scale (DSQL) at baseline and 12 weeks
Measured: baseline and 12 weeks
Treatment compliance
Measured: up to 12 weeks
Diabetes Treatment Satisfaction
measured by Diabetes Treatment Satisfaction Questionnaire (DTSQs) at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilin Sun, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143765
- Sponsor's protocol ID
- ZhongdaH-Match
- Acronym
- Match-101
- Status last verified
- Jul 2016
- First submitted
- 3 May 2014
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
LV Xiaofeng. Clinical study on efficacy and safety of mitiglinide on type 2 diabetes mellitus. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(2):175-179.
Zhu Q, Tong Y, Wu T, Li J, Tong N. Comparison of the hypoglycemic effect of acarbose monotherapy in patients with type 2 diabetes mellitus consuming an Eastern or Western diet: a systematic meta-analysis. Clin Ther. 2013 Jun;35(6):880-99. doi: 10.1016/j.clinthera.2013.03.020. Epub 2013 Apr 18.
PubMed 23602502
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Mitiglinide Versus Acarbose in Patients With Type 2 Diabetes Mellitus in China
- ClinicalTrials.gov ID
- NCT02143765
- Acronym / sponsor ID
- Match-101 / ZhongdaH-Match
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Mitiglinide, Acarbose, Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2014 (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.
Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control.
This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in patients with type 2 diabetes mellitus.
Detailed description
Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248, randomized to 2 groups at ratio of 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitiglinide | Experimental | Drug: MitiglinideMitiglinide 10 mg three times a day, orally, for 12 weeks |
| Acarbose | Active comparator | Drug: AcarboseAcarbose 50 mg three times a day, orally, for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged between 18 and 70, regardless of gender
- Subjects with type-2 diabetes mellitus diagnosed according to 1999 WHO criteria within 5 years
- Subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors
- Subjects whose fasting blood glucose [FBG] between7.0 and10.0 mmol/L and HbA1c ratio is between 7.0% and 10.0%
- Note: Incretin mimetics contain glucagon-like peptide 1 (GLP-1) receptor agonist (including GLP-1 analogues) and dipeptidyl peptidase 4 inhibitors.
Key exclusion criteria (9 listed)
- Subjects with abnormal hepatic function whose aspartate transaminase (AST) and alanine transaminase (ALT) are 2 times higher than the upper limits of normal (ULN)
- Subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 ULN or positive urine protein
- Subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease
- Subjects who have chronic intestinal diseases associated with marked disorders of digestion or absorption and may deteriorate as a result of increased gas formation in the intestine (like Gastrocardiac Syndrome, severe hernia, intestinal obstruction, intestinal ulcer and intestinal surgery)
- Subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc.
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: FADIthree times a day, orally, for 12 weeks | Drug | Mitiglinide |
| AcarboseAlso: PRECOSEthree times a day, orally, for 12 weeks | Drug | Acarbose |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline and Week 12
5 secondary outcomes
the change from baseline to the end of treatment in fasting blood glucose (FBG), postprandial blood glucose (PBG)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: up to 12 weeks
the change from baseline to the end of treatment in Diabetes Quality of Life
Time frame: baseline and 12 weeks
Treatment compliance
Time frame: up to 12 weeks
Diabetes Treatment Satisfaction
Time frame: 12 weeks
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 14 Jul 2016.
- Results publicationLV Xiaofeng. Clinical study on efficacy and safety of mitiglinide on type 2 diabetes mellitus. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(2):175-179.
- Results publication: PubMed 23602502Zhu Q, Tong Y, Wu T, Li J, Tong N. Comparison of the hypoglycemic effect of acarbose monotherapy in patients with type 2 diabetes mellitus consuming an Eastern or Western diet: a systematic meta-analysis. Clin Ther. 2013 Jun;35(6):880-99. doi: 10.1016/j.clinthera.2013.03.020. Epub 2013 Apr 18.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 Mitiglinide and Acarbose in people with Type 2 Diabetes Mellitus, run by Zhongda Hospital at 6 sites in China.
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 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143765, which also lists 2 linked publications.
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 14 Jul 2016.