Type 2 DiabetesPhase 2NCT02317796
Adult Subjects With Uncontrolled Type 2 Diabetes
A Phase 2 study testing MLR-1023 in people with Type 2 Diabetes, run by Melior Pharmaceuticals at 1 site in United States.
Trial summary
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- MLR-1023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Feb 2016
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged ≥ 18 - ≤ 75 years
- Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception
- BMI ranging from ≥ 20 to ≤ 40 kg/m2
- Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3)
- (i) naïve or (ii) currently using and discontinued metformin or (iii) no prior exposure to anti-diabetic agents other than metformin ≥ 6 months prior to screening
Who cannot join
- History of Type 1 diabetes
- History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness.
- Hospitalizations or Emergency room visits that would impact patient safety or data interpretation:
- Due to poor glucose control in the 6 months prior to screening or
- Any bariatric surgical procedures for weight loss.
- Significant change of body weight (>10%) in the 3 months before screening
- Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
USA and South Korea, Pennsylvania
About this study
Official title: A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
Read the detailed description
Objectives
- To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus
- To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1 following 28 days of repeat dosing
Design and Outcomes
The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023 in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise therapy.
A subset of subjects per dose group will have additional samples analyzed to measure signs of MLR-1023.
- Conditions
- Type 2 Diabetes
- Being tested
- MLR-1023
- 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.
MLR-1023Drug
Each subject will receive an oral dose of placebo or MLR-1023 once before breakfast and either placebo (placebo and q.d. dose groups) or a second dose of MLR-1023 (b.i.d. dose groups) before dinner for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: MLR-1023 |
| 100 mg q.d. | Active comparator | Not described Receives: Drug: MLR-1023 |
| 100 mg b.i.d. | Active comparator | Not described Receives: Drug: MLR-1023 |
| 200 mg q.d. | Active comparator | Not described Receives: Drug: MLR-1023 |
| 200 mg b.i.d. | Active comparator | Not described Receives: Drug: MLR-1023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PPG AUC0-3h in a MMTT between Days 1 and 29.
Measured: 29 Days
Secondary outcomes (10)
Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36
Measured: 36 Days
Change in fructosamine level from Day 1 to Day 29
Measured: 29 Days
Change in fasting insulin from Day 1 to Day 29
Measured: 29 Days
Change in glycated albumin from Day 1 to Day 29
Measured: 29 Days
Change from Day 1 to Day 29 in insulin sensitivity using HOMA-R (HOMA-R = fasting plasma insulin (mU/l) * fasting plasma glucose (mmol/l) / 22.5)
Measured: 29 Days
Changes from Day 1 to Day 29 in beta-cell function using HOMA-B (HOMA-B = 20 * fast- ing plasma insulin (mU/l) / [fasting plasma glucose (mmol/l) - 3.5])
Measured: 29 Days
Change in HbA1C between Days 1 and Day 29
Measured: 29 Days
Changes in LDL-C, HDL-C, TG between Days 1 and Day 29
Measured: 29 Days
Change in weight between Days 1 and Day 29
Measured: 29 Days
Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29.
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melior Pharmaceuticals
- Sponsor type
- University, hospital or other
- Collaborators
- Bukwang Pharmaceutical, Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd., Study director, Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317796
- Sponsor's protocol ID
- BK-MD-201
- Status last verified
- Sep 2016
- First submitted
- 11 Dec 2014
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undecided
Publications
Lee MK, Kim SG, Watkins E, Moon MK, Rhee SY, Frias JP, Chung CH, Lee SH, Block B, Cha BS, Park HK, Kim BJ, Greenway F. A novel non-PPARgamma insulin sensitizer: MLR-1023 clinicalproof-of-concept in type 2 diabetes mellitus. J Diabetes Complications. 2020 May;34(5):107555. doi: 10.1016/j.jdiacomp.2020.107555. Epub 2020 Feb 2.
PubMed 32019723
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02317796
- Acronym / sponsor ID
- BK-MD-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Melior PharmaceuticalsUniversity, hospital or other
- Collaborators
- Bukwang Pharmaceutical, Co., Ltd.
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Dec 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.
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
Detailed description
Objectives
- To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus
- To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1 following 28 days of repeat dosing
Design and Outcomes
The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023 in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise therapy.
A subset of subjects per dose group will have additional samples analyzed to measure signs of MLR-1023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: MLR-1023 |
| 100 mg q.d. | Active comparator | Drug: MLR-1023 |
| 100 mg b.i.d. | Active comparator | Drug: MLR-1023 |
| 200 mg q.d. | Active comparator | Drug: MLR-1023 |
| 200 mg b.i.d. | Active comparator | Drug: MLR-1023 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged ≥ 18 - ≤ 75 years
- Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception
- BMI ranging from ≥ 20 to ≤ 40 kg/m2
- Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3)
- (i) naïve or (ii) currently using and discontinued metformin or (iii) no prior exposure to anti-diabetic agents other than metformin ≥ 6 months prior to screening
Key exclusion criteria (7 listed)
- History of Type 1 diabetes
- History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness.
- Hospitalizations or Emergency room visits that would impact patient safety or data interpretation:
- Significant change of body weight (>10%) in the 3 months before screening
- Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy
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 |
|---|---|---|
| MLR-1023Each subject will receive an oral dose of placebo or MLR-1023 once before breakfast and either placebo (placebo and q.d. dose groups) or a second dose of MLR-1023 (b.i.d. dose groups) before dinner for 4 weeks. | Drug | 100 mg b.i.d., 100 mg q.d., 200 mg b.i.d., 200 mg q.d., Placebo |
Primary outcome
Change in PPG AUC0-3h in a MMTT between Days 1 and 29.
Time frame: 29 Days
10 secondary outcomes
Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36
Time frame: 36 Days
Change in fructosamine level from Day 1 to Day 29
Time frame: 29 Days
Change in fasting insulin from Day 1 to Day 29
Time frame: 29 Days
Change in glycated albumin from Day 1 to Day 29
Time frame: 29 Days
Change from Day 1 to Day 29 in insulin sensitivity using HOMA-R (HOMA-R = fasting plasma insulin (mU/l) * fasting plasma glucose (mmol/l) / 22.5)
Time frame: 29 Days
Changes from Day 1 to Day 29 in beta-cell function using HOMA-B (HOMA-B = 20 * fast- ing plasma insulin (mU/l) / [fasting plasma glucose (mmol/l) - 3.5])
Time frame: 29 Days
Change in HbA1C between Days 1 and Day 29
Time frame: 29 Days
Changes in LDL-C, HDL-C, TG between Days 1 and Day 29
Time frame: 29 Days
Change in weight between Days 1 and Day 29
Time frame: 29 Days
Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29.
Time frame: 29 Days
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 26 Sep 2016.
- Derived from this study: PubMed 32019723Lee MK, Kim SG, Watkins E, Moon MK, Rhee SY, Frias JP, Chung CH, Lee SH, Block B, Cha BS, Park HK, Kim BJ, Greenway F. A novel non-PPARgamma insulin sensitizer: MLR-1023 clinicalproof-of-concept in type 2 diabetes mellitus. J Diabetes Complications. 2020 May;34(5):107555. doi: 10.1016/j.jdiacomp.2020.107555. Epub 2020 Feb 2.
- Individual participant dataSharing planned: Undecided. 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.
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd. study director
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLR-1023 in people with Type 2 Diabetes, run by Melior Pharmaceuticals at 1 site in United States.
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 7 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 26 Sep 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in PPG AUC0-3h in a MMTT between Days 1 and 29. (time frame: 29 Days). 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 NCT02317796, which also lists 1 linked publication.
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 26 Sep 2016.