Type 2 Diabetes MellitusPhase 2NCT03406377
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
A Phase 2 study testing OPK-88003 in people with Type 2 Diabetes Mellitus, run by OPKO Health, Inc. at 3 sites in United States.
Trial summary
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- OPK-88003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Apr 2018to 27 Jun 2019
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),
- BMI ≥27 and ≤45 kg/m2
- HbA1c ≥7.0% and ≤10.5% at screening
Who cannot join
- Type 1 diabetes mellitus
- Previous treatment with incretin mimetic drugs
- Have used insulin for diabetic control for more than 6 consecutive days within the prior year
- Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months
- Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (>2 x ULN).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami, LLC
Hialeah, Florida, 33014
National Research Institute - Huntington Park
Huntington Park, California, 90255
National Research Institute - Wilshire
Los Angeles, California, 90057
About this study
Official title: A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
Read the detailed description
This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- OPK-88003, Placebo
- 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.
OPK-88003Drug
OPK-88003 subcutaneous injection
PlaceboDrug
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate Receives: Drug: Placebo |
| OPK-88003 | Experimental | 70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks) Receives: Drug: OPK-88003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c in Subjects With Type 2 DM
To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
Measured: From baseline to 30 weeks
Secondary outcomes (3)
Mean Percent (%) Body Weight Change
Mean percent (%) body weight change from baseline to after 30 weeks treatment
Measured: From baseline to 30 weeks
Percent (%) of Subjects With 5% or Greater Body Weight Loss.
Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment
Measured: 30 weeks.
Change From Baseline of Fasting Plasma Glucose (FPG).
Change of FPG from baseline to after 30 weeks treatment
Measured: 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start2 Apr 2018
- Primary completion8 Mar 2019
- Study completion27 Jun 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Militza Vera De Alba, MD, Study director, OPKO Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406377
- Sponsor's protocol ID
- DPO-203
- Status last verified
- May 2021
- First submitted
- 15 Jan 2018
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03406377
- Acronym / sponsor ID
- DPO-203
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
Detailed description
This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboWater for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate |
| OPK-88003 | Experimental | Drug: OPK-8800370 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),
- BMI ≥27 and ≤45 kg/m2
- HbA1c ≥7.0% and ≤10.5% at screening
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus
- Previous treatment with incretin mimetic drugs
- Have used insulin for diabetic control for more than 6 consecutive days within the prior year
- Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months
- Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (>2 x ULN).
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 |
|---|---|---|
| OPK-88003OPK-88003 subcutaneous injection | Drug | OPK-88003 |
| PlaceboPlacebo subcutaneous injection | Drug | Placebo |
Primary outcome
Change in HbA1c in Subjects With Type 2 DM
Time frame: From baseline to 30 weeks
To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
3 secondary outcomes
Mean Percent (%) Body Weight Change
Time frame: From baseline to 30 weeks
Percent (%) of Subjects With 5% or Greater Body Weight Loss.
Time frame: 30 weeks.
Change From Baseline of Fasting Plasma Glucose (FPG).
Time frame: 30 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Militza Vera De Alba, MD study director
OPKO Health, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPK-88003 in people with Type 2 Diabetes Mellitus, run by OPKO Health, Inc. at 3 sites 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 3 inclusion and 5 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 15 Jun 2021). 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?
Change in HbA1c in Subjects With Type 2 DM (time frame: From baseline to 30 weeks). 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 15 Jun 2021.