Type 2 Diabetes MellitusPhase 1NCT01614782
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)
A Phase 1 study testing MK-5823 in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MK-5823
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Oct 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of non-childbearing potential
- A Body Mass Index between 27 and 35 kg/m^2 and weighs at least 50 kg
- Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM
- For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin
- A nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Who cannot join
- History of stroke, chronic seizures or major neurological disorder
- History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)
- Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.
- History of neoplastic disease
- History of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness
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- Requires treatment with systemic or ocular corticosteroids
- For T2DM Panels, a history of hypoglycemic unawareness
- For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin
- For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation
- Unable to refrain from using any medication beginning 2 weeks before study participation
- Consumes excessive amounts of alcohol (>3 per day)
- Consumes more than 6 caffeinated beverages per day
- Had major surgery or donated or lost more than 1 unit of blood
- Participated in another investigational study within 4 weeks of study participation
- History of significant multiple and/or severe allergies or anaphylactic reaction
- Hypersensitivity to glucagon or insulin
- Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation
- Woman of child-bearing potential or is a nursing mother
- For T2DM Panels, age >50 years
About this study
Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Healthy Overweight/Obese Subjects and Patients With Type 2 Diabetes Mellitus
The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MK-5823, 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.
MK-5823Drug
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.
In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
PlaceboOther
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 0.35 mg MK-5823 - Healthy Participants | Experimental | Not described Receives: Drug: MK-5823; Other: Placebo |
| 0.7 mg MK-5823 - Healthy Participants | Experimental | Not described Receives: Drug: MK-5823; Other: Placebo |
| 1.4 mg MK-5823 - Healthy Participants | Experimental | Not described Receives: Drug: MK-5823; Other: Placebo |
| 2.8 mg MK-5823 - Healthy Participants | Experimental | Not described Receives: Drug: MK-5823; Other: Placebo |
| 1.4 mg MK-5823 - Participants with T2DM | Experimental | Not described Receives: Drug: MK-5823; Other: Placebo |
| 2.8 mg MK-5823 - Participants with T2DM | Experimental | Not described Receives: Drug: MK-5823; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experienced at least one adverse event
Measured: Up to 49 days
Number of participants who discontinued from study drug due to an adverse event
Measured: Up to 21 days
Secondary outcomes (5)
Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823
Measured: Predose on Day 1 (baseline) through 672 hours following the initial dose
Maximum plasma concentration (Cmax) following once daily administration of MK-5823
Measured: Predose on Day 1 (baseline) through 672 hours following the initial dose
Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
Measured: Predose on Day 1 (baseline) through 672 hours following the initial dose
Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823
Measured: Predose on Day 1 (baseline) through 672 hours following the initial dose
Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823
Measured: Predose on Day 1 (baseline) through 672 hours following the initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614782
- Sponsor's protocol ID
- 5823-002
- Status last verified
- Feb 2016
- First submitted
- 6 Jun 2012
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Healthy Overweight/Obese Subjects and Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01614782
- Acronym / sponsor ID
- 5823-002
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Jun 2012 (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 assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.35 mg MK-5823 - Healthy Participants | Experimental | Drug: MK-5823, Other: Placebo |
| 0.7 mg MK-5823 - Healthy Participants | Experimental | Drug: MK-5823, Other: Placebo |
| 1.4 mg MK-5823 - Healthy Participants | Experimental | Drug: MK-5823, Other: Placebo |
| 2.8 mg MK-5823 - Healthy Participants | Experimental | Drug: MK-5823, Other: Placebo |
| 1.4 mg MK-5823 - Participants with T2DM | Experimental | Drug: MK-5823, Other: Placebo |
| 2.8 mg MK-5823 - Participants with T2DM | Experimental | Drug: MK-5823, Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female of non-childbearing potential
- A Body Mass Index between 27 and 35 kg/m^2 and weighs at least 50 kg
- Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM
- For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin
- A nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Key exclusion criteria (20 listed)
- History of stroke, chronic seizures or major neurological disorder
- History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)
- Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.
- History of neoplastic disease
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 |
|---|---|---|
| MK-5823MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo. | Drug | 0.35 mg MK-5823 - Healthy Participants, 0.7 mg MK-5823 - Healthy Participants, 1.4 mg MK-5823 - Healthy Participants, 1.4 mg MK-5823 - Participants with T2DM, 2.8 mg MK-5823 - Healthy Participants, 2.8 mg MK-5823 - Participants with T2DM |
| PlaceboMatching placebo to MK-5823 administered subcutaneously once daily for 3 weeks. | Other | 0.35 mg MK-5823 - Healthy Participants, 0.7 mg MK-5823 - Healthy Participants, 1.4 mg MK-5823 - Healthy Participants, 1.4 mg MK-5823 - Participants with T2DM, 2.8 mg MK-5823 - Healthy Participants, 2.8 mg MK-5823 - Participants with T2DM |
Primary outcome
Number of participants who experienced at least one adverse event
Time frame: Up to 49 days
Number of participants who discontinued from study drug due to an adverse event
Time frame: Up to 21 days
5 secondary outcomes
Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Maximum plasma concentration (Cmax) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-5823 in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
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 20 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: stopped early, as of the sponsor's last update on 5 Feb 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Number of participants who experienced at least one adverse event (time frame: Up to 49 days). The study lists 2 primary outcomes in all. 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 5 Feb 2016.