Chronic Renal InsufficiencyPhase 1NCT01407276
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
A Phase 1 study testing Omarigliptin in people with Chronic Renal Insufficiency and Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency, Type 2 Diabetes Mellitus
- What is being tested?
- Omarigliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2011to 23 Mar 2012
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impaired Renal Function Subjects:
- Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
- Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation
- Healthy Subjects:
- Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
- In general good health
Who cannot join
- Impaired Renal Function Subjects:
- Is mentally or legally incapacitated
- Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
- History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
- History of stroke, chronic seizures or major neurological disease
- Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
Show all 28Show fewer
- History of cancer (Some exceptions apply)
- Regular user of barbiturates or sleep aides
- Consumes excessive amounts of alcohol (more than 2 drinks/day)
- Consumes excessive amounts of caffeinated beverages (more than 6/day)
- Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
- Has a history of significant multiple and/or severe allergies
- Current or history of illicit drug abuse
- Nursing mothers
- Healthy Subjects:
- Is mentally or legally incapacitated;
- Has a history of stroke, chronic seizures, or major neurological disorder
- Renal impairment
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
- Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
- History of cancer (Some exceptions apply)
- Regular user of barbiturates or sleep aides
- Consumes excessive amounts of alcohol (more than 2 drinks/day)
- Consumes excessive amounts of caffeinated beverages (more than 6/day)
- Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
- Has a history of significant multiple and/or severe allergies
- Current or history of illicit drug abuse
- Nursing mothers
About this study
Official title: An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MK-3102 in Patients With Impaired Renal Function
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.
Read the detailed description
In Part I, three panels of 6 participants each will be enrolled with varying degrees of renal disease (mild, moderate, or severe renal impairment) based on their estimated glomerular filtration rate (eGFR). Each of these panels will be matched with a corresponding panel of equal number of healthy, age-, race-, BMI- and gender-matched control participants. All panels will receive a single oral dose of 3-mg omarigliptin, followed by plasma sampling and urine collection. In Part II, 6 participants with end stage renal disease (ESRD) requiring hemodialysis will receive a single 3-mg oral dose of omarigliptin immediately following hemodialysis (HD) (Period 1) and 2 hours prior to HD (Period 2).There will be approximately 1 month between Period 1 and Period 2. A corresponding panel of equal number, healthy matched control subjects (age, race, BMI, gender) will also receive a single 3 mg dose by mouth. Omarigliptin dose administration will be followed by plasma sampling for both panels.
- Being tested
- Omarigliptin
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmarigliptinDrug
Also called MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Mild Renal Impairment (Panel A) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 1: Control to Match Panel A (Panel B) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 1: Moderate Renal Impairment (Panel C) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 1: Control to Match Panel C (Panel D) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 1: Severe Renal Impairment (Panel E) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 1: Control to Match Panel E (Panel F) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 2: End-stage Renal Disease needing hemodialysis (Panel G) | Experimental | Not described Receives: Drug: Omarigliptin |
| Part 2: Control to Match Panel G (Panel H) | Experimental | Not described Receives: Drug: Omarigliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
Maximum Concentration (Cmax) of Omarigliptin
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin
AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose
Concentration at 168 Hours Post-dose (C168h) of Omarigliptin
C168h is a measure of the plasma drug concentration 168 hours post-dose.
Measured: 168 hours post-dose
Apparent Volume of Distribution (Vd/F) of Omarigliptin
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
Measured: Up to 336 hours post-dose
Apparent Total Body Clearance (CL/F) of Omarigliptin
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Measured: Up to 336 hours post-dose
Renal Clearance (CLr) of Omarigliptin
CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.
Measured: Up to 336 hours post-dose
Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin
fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.
Measured: Up to 48 hours post-dose
Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin
Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.
Measured: Up to 48 hours post-dose
Time to Maximum Concentration (Tmax) of Omarigliptin
Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
Apparent Terminal Half-life (t1/2) of Omarigliptin
T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
Secondary outcomes (2)
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
Measured: From pre-dose to 14 days post-dose (Up to Day 15)
Number of Participants Withdrawn From Study
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study start8 Aug 2011
- Primary completion23 Mar 2012
- Study completion23 Mar 2012
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 Chronic Renal InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407276
- Sponsor's protocol ID
- 3102-009
- Status last verified
- Aug 2018
- First submitted
- 29 Jul 2011
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MK-3102 in Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01407276
- Acronym / sponsor ID
- 3102-009
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2011 (actual)
- Primary completion
- 23 Mar 2012 (actual)
- Study completion
- 23 Mar 2012 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Posted 3 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.
Detailed description
In Part I, three panels of 6 participants each will be enrolled with varying degrees of renal disease (mild, moderate, or severe renal impairment) based on their estimated glomerular filtration rate (eGFR). Each of these panels will be matched with a corresponding panel of equal number of healthy, age-, race-, BMI- and gender-matched control participants. All panels will receive a single oral dose of 3-mg omarigliptin, followed by plasma sampling and urine collection. In Part II, 6 participants with end stage renal disease (ESRD) requiring hemodialysis will receive a single 3-mg oral dose of omarigliptin immediately following hemodialysis (HD) (Period 1) and 2 hours prior to HD (Period 2).There will be approximately 1 month between Period 1 and Period 2. A corresponding panel of equal number, healthy matched control subjects (age, race, BMI, gender) will also receive a single 3 mg dose by mouth. Omarigliptin dose administration will be followed by plasma sampling for both panels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: Mild Renal Impairment (Panel A) | Experimental | Drug: Omarigliptin |
| Part 1: Control to Match Panel A (Panel B) | Experimental | Drug: Omarigliptin |
| Part 1: Moderate Renal Impairment (Panel C) | Experimental | Drug: Omarigliptin |
| Part 1: Control to Match Panel C (Panel D) | Experimental | Drug: Omarigliptin |
| Part 1: Severe Renal Impairment (Panel E) | Experimental | Drug: Omarigliptin |
| Part 1: Control to Match Panel E (Panel F) | Experimental | Drug: Omarigliptin |
| Part 2: End-stage Renal Disease needing hemodialysis (Panel G) | Experimental | Drug: Omarigliptin |
| Part 2: Control to Match Panel G (Panel H) | Experimental | Drug: Omarigliptin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
- Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation
- Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
- In general good health
Key exclusion criteria (28 listed)
- Is mentally or legally incapacitated
- Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
- History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
- History of stroke, chronic seizures or major neurological disease
- Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
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 |
|---|---|---|
| OmarigliptinAlso: MK-3102Single oral dose of 3 mg (3 x 1-mg capsules) | Drug | Part 1: Control to Match Panel A (Panel B), Part 1: Control to Match Panel C (Panel D), Part 1: Control to Match Panel E (Panel F), Part 1: Mild Renal Impairment (Panel A), Part 1: Moderate Renal Impairment (Panel C), Part 1: Severe Renal Impairment (Panel E), Part 2: Control to Match Panel G (Panel H), Part 2: End-stage Renal Disease needing hemodialysis (Panel G) |
Primary outcome
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Maximum Concentration (Cmax) of Omarigliptin
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose
AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.
Concentration at 168 Hours Post-dose (C168h) of Omarigliptin
Time frame: 168 hours post-dose
C168h is a measure of the plasma drug concentration 168 hours post-dose.
Apparent Volume of Distribution (Vd/F) of Omarigliptin
Time frame: Up to 336 hours post-dose
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
Apparent Total Body Clearance (CL/F) of Omarigliptin
Time frame: Up to 336 hours post-dose
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Renal Clearance (CLr) of Omarigliptin
Time frame: Up to 336 hours post-dose
CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.
Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin
Time frame: Up to 48 hours post-dose
fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.
Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin
Time frame: Up to 48 hours post-dose
Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.
Time to Maximum Concentration (Tmax) of Omarigliptin
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.
Apparent Terminal Half-life (t1/2) of Omarigliptin
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.
2 secondary outcomes
Number of Participants Experiencing an Adverse Event (AE)
Time frame: From pre-dose to 14 days post-dose (Up to Day 15)
Number of Participants Withdrawn From Study
Time frame: Up to Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omarigliptin in people with Chronic Renal Insufficiency and 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 6 inclusion and 28 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 10 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2015). 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?
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin (time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose). The study lists 11 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 10 Sep 2018.