Type 2 DiabetesPhase 4ACACIANCT04810507
MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus
A Phase 4 study testing Anagliptin BID Treatment in people with Type 2 Diabetes, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Anagliptin BID Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2018to 5 Jan 2021
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 DM
- Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
- 6.5% ≤HbA1c< 8.5%
- Agreed Therapeutic Lifestyle change during the study period
- Obtained Informed Consent Form
Who cannot join
- Type 1 diabetes mellitus,
- History of intestinal obstruction
- NYHA class III to IV congestive heart failure,
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 X upper limit of normal (ULN) or Total bilirubin > 3 X ULN
- Creatinine clearance (CrCl)* < 50 mL/min
- Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN
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- Allergic history for Anagliptin 또는 sitagliptin
- Being pregnant or nursing or suspected of being pregnant, or
- History of participation in other clinical studies in the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Active Controlled, Randomized, Double-blinded, Parallel, Phase IV Study to Evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared With Sitagliptin in Patients With Type 2 Diabetes Mellitus
An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus
Read the detailed description
This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).
- Conditions
- Type 2 Diabetes
- Being tested
- Anagliptin BID Treatment
- 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.
Anagliptin BID TreatmentDrug
Also called Sitagliptin QD Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anagliptin arm | Experimental | Anagliptin 100 mg twice a day Receives: Drug: Anagliptin BID Treatment |
| Sitagliptin 100mg | Active comparator | Sitagliptin 100mg once a day Receives: Drug: Anagliptin BID Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Improving Glycemic Variability
Mean amplitude of glycemic excursion (MAGE)
Measured: 3 days after 12 weeks treatment
Secondary outcomes (1)
Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline
after 12 weeks compared to baseline in the test group and the control group
Measured: after 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start9 Nov 2018
- Primary completion2 Sep 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaewan Park, Study director, JWPharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810507
- Sponsor's protocol ID
- JWP-GDL-404
- Acronym
- ACACIA
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Active Controlled, Randomized, Double-blinded, Parallel, Phase IV Study to Evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared With Sitagliptin in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04810507
- Acronym / sponsor ID
- ACACIA / JWP-GDL-404
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- 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.
An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus
Detailed description
This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study
| Arm | Type | Receives |
|---|---|---|
| Anagliptin arm | Experimental | Drug: Anagliptin BID TreatmentAnagliptin 100 mg twice a day |
| Sitagliptin 100mg | Active comparator | Drug: Anagliptin BID TreatmentSitagliptin 100mg once a day |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 DM
- Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
- 6.5% ≤HbA1c< 8.5%
- Agreed Therapeutic Lifestyle change during the study period
- Obtained Informed Consent Form
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus,
- History of intestinal obstruction
- NYHA class III to IV congestive heart failure,
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 X upper limit of normal (ULN) or Total bilirubin > 3 X ULN
- Creatinine clearance (CrCl)* < 50 mL/min
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 |
|---|---|---|
| Anagliptin BID TreatmentAlso: Sitagliptin QD TreatmentContinuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks | Drug | Anagliptin arm, Sitagliptin 100mg |
Primary outcome
Effect of Improving Glycemic Variability
Time frame: 3 days after 12 weeks treatment
Mean amplitude of glycemic excursion (MAGE)
1 secondary outcome
Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline
Time frame: after 12 weeks treatment
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 24 Mar 2021.
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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.
Jaewan Park study director
JWPharmaceuticals
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 Anagliptin BID Treatment in people with Type 2 Diabetes, run by JW Pharmaceutical 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 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 24 Mar 2021. 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?
Effect of Improving Glycemic Variability (time frame: 3 days after 12 weeks treatment). 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 24 Mar 2021.