Type 2 Diabetes MellitusPhase 1NCT00757601
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
A Phase 1 study testing MK1006 in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MK1006
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Dec 2008
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C
- Female participants must be postmenopausal or otherwise unable to have children
- Participant has a body mass index (BMI) less than or equal to 42 kg/m^2 at the screening visit
- Participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. For Panels B and C, participant may be treated with combination oral anti-hyperglycemic medications
- Participant is willing to follow the American Heart Association (AHA) diet and exercise program throughout the study
- Participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start
Who cannot join
- Participant has a history of stroke, seizures, or other neurological disorders
- Participant has a recent history of eye infection or other inflammatory eye conditions
- Participant has glaucoma or is blind
- Participant has had eye surgery within 6 months of study start (Lasik is permitted)
- Participant has type 1 diabetes
- Participant cannot stop taking any of their current prescription or non-prescription medications during the study
Show all 10Show fewer
- Participant consumes more than 3 alcoholic beverages per day
- Participant consumes more than 6 caffeinated beverages per day
- Participant has had major surgery or has donated blood within 4 weeks of study start
- Participant has multiple and/or severe allergies to drugs or food
About this study
Official title: A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006.
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MK1006, 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.
MK1006Drug
MK1006 capsules: 1 mg, 10 mg, and 20 mg.
Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg
Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg.
Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg.
There will a 7-day interval between each dose
PlaceboDrug
Placebo capsule to match MK1006 1, 10, and 20 mg.
Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg
Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg.
Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg.
There will a 7-day interval between each dose
| Study group | Role | What they receive |
|---|---|---|
| 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed) | Experimental | Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) | Experimental | Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed) | Experimental | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed) | Experimental | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo | Experimental | Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006 | Experimental | Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5 Receives: Drug: MK1006; Drug: Placebo |
| 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006 | Experimental | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006 | Experimental | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo | Experimental | Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006 | Experimental | Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. Receives: Drug: MK1006; Drug: Placebo |
| 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006 | Experimental | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5 Receives: Drug: MK1006; Drug: Placebo |
| 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006 | Experimental | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. Receives: Drug: MK1006; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs) On Study
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Measured: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
Number of Participants Who Discontinued Treatment Due to an AE
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Measured: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
Secondary outcomes (5)
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Measured: From pre-dose to 168 hours post-dose
Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
Measured: From pre-dose to 168 hours post-dose
Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
Measured: From pre-dose to 168 hours post-dose
Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination
Measured: From pre-dose to 168 hours post-dose
Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006
The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.
Measured: From pre-dose to 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionDec 2008
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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757601
- Sponsor's protocol ID
- 1006-002
- Other IDs
- 2008_549
- Status last verified
- Feb 2016
- First submitted
- 22 Sep 2008
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006.
- ClinicalTrials.gov ID
- NCT00757601
- Acronym / sponsor ID
- 1006-002
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Posted 7 Sep 2012
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 assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed) | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. |
| Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) | Experimental | Drug: MK1006, Drug: PlaceboParticipants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed) | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed) | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
| Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006 | Experimental | Drug: MK1006, Drug: PlaceboParticipants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5 |
| 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006 | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006 | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
| Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006 | Experimental | Drug: MK1006, Drug: PlaceboParticipants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
| 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006 | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5 |
| 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006 | Experimental | Drug: MK1006, Drug: PlaceboParticipants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C
- Female participants must be postmenopausal or otherwise unable to have children
- Participant has a body mass index (BMI) less than or equal to 42 kg/m^2 at the screening visit
- Participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. For Panels B and C, participant may be treated with combination oral anti-hyperglycemic medications
- Participant is willing to follow the American Heart Association (AHA) diet and exercise program throughout the study
Key exclusion criteria (10 listed)
- Participant has a history of stroke, seizures, or other neurological disorders
- Participant has a recent history of eye infection or other inflammatory eye conditions
- Participant has glaucoma or is blind
- Participant has had eye surgery within 6 months of study start (Lasik is permitted)
- Participant has type 1 diabetes
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 |
|---|---|---|
| MK1006MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose | Drug | 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo, 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006, 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006, 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed), 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed), 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed), 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo, 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006, 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006, Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006, Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006, Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) |
| PlaceboPlacebo capsule to match MK1006 1, 10, and 20 mg. Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose | Drug | 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo, 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006, 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006, 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed), 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed), 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed), 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo, 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006, 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006, Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006, Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006, Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs) On Study
Time frame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Number of Participants Who Discontinued Treatment Due to an AE
Time frame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
5 secondary outcomes
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
Time frame: From pre-dose to 168 hours post-dose
Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
Time frame: From pre-dose to 168 hours post-dose
Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
Time frame: From pre-dose to 168 hours post-dose
Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
Time frame: From pre-dose to 168 hours post-dose
Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006
Time frame: From pre-dose to 168 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 2 Diabetes Mellitus
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK1006 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 6 inclusion and 10 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 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?
Yes. Results are posted in the registry (first posted 7 Sep 2012). 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?
Number of Participants Experiencing Adverse Events (AEs) On Study (time frame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)). 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.