Type 2 Diabetes MellitusPhase 1NCT00902161
A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
A Phase 1 study testing MK0893 and Propranolol Hydrochloride (HCL) in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MK0893 and Propranolol Hydrochloride (HCL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Nov 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant has Type 2 Diabetes (T2DM)
- Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
- Participant has not received insulin for at least 6 months
- Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
- Participant has been a nonsmoker for at least 6 months
- Female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods
Who cannot join
- Participant has a history of stroke, seizures, or neurological disorders
- Participant cannot tolerate insulin or propranolol
- Participant has a history of asthma, emphysema or chronic bronchitis
- Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
- Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
- Participant has a history of heart failure or coronary artery disease
Show all 10Show fewer
- Participant has a history of uncontrolled high blood pressure
- Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive
- Participant has a history of Type 1 diabetes
- Participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes
This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MK0893, MK0893-matched Placebo, Propranolol Hydrochloride (HCL)
- 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.
MK0893Drug
Single dose of MK0893 1000 mg (ten 100 mg tablets)
MK0893-matched PlaceboDrug
Single dose of placebo to MK0893 (ten tablets)
Propranolol Hydrochloride (HCL)Drug
Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Propanolol + Placebo > Propanolol + MK0893 | Experimental | Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8). Receives: Drug: MK0893; Drug: MK0893-matched Placebo; Drug: Propranolol Hydrochloride (HCL) |
| Propanolol + MK0893 > Propanolol + Placebo | Placebo comparator | Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8). Receives: Drug: MK0893; Drug: MK0893-matched Placebo; Drug: Propranolol Hydrochloride (HCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Time (Rt[65] From Insulin-induced Hypoglycemia
Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes
Measured: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes
Secondary outcomes (4)
Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893
Cmax was the maximum or "peak" concentration of MK0893 observed after its administration.
Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4
Measured: From time of MK0893 administration through 24 hours post-dose
Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893
Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve
Measured: From time of MK0893 administration through estimated 32 hours post-dose
Number of Participants With An Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product.
Measured: From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).
Number of Participants Who Discontinued Study Treatment Due To AEs
An AE was defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product.
Measured: From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionNov 2009
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
- 22 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
- NCT00902161
- Sponsor's protocol ID
- 0893-019
- Other IDs
- 2009_592
- Status last verified
- Jun 2015
- First submitted
- 13 May 2009
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00902161
- Acronym / sponsor ID
- 0893-019
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 8 May 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 effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propanolol + Placebo > Propanolol + MK0893 | Experimental | Drug: MK0893, Drug: MK0893-matched Placebo, Drug: Propranolol Hydrochloride (HCL)Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8). |
| Propanolol + MK0893 > Propanolol + Placebo | Placebo comparator | Drug: MK0893, Drug: MK0893-matched Placebo, Drug: Propranolol Hydrochloride (HCL)Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant has Type 2 Diabetes (T2DM)
- Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
- Participant has not received insulin for at least 6 months
- Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
- Participant has been a nonsmoker for at least 6 months
Key exclusion criteria (10 listed)
- Participant has a history of stroke, seizures, or neurological disorders
- Participant cannot tolerate insulin or propranolol
- Participant has a history of asthma, emphysema or chronic bronchitis
- Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
- Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
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 |
|---|---|---|
| MK0893Single dose of MK0893 1000 mg (ten 100 mg tablets) | Drug | Propanolol + MK0893 > Propanolol + Placebo, Propanolol + Placebo > Propanolol + MK0893 |
| MK0893-matched PlaceboSingle dose of placebo to MK0893 (ten tablets) | Drug | Propanolol + MK0893 > Propanolol + Placebo, Propanolol + Placebo > Propanolol + MK0893 |
| Propranolol Hydrochloride (HCL)Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks. | Drug | Propanolol + MK0893 > Propanolol + Placebo, Propanolol + Placebo > Propanolol + MK0893 |
Primary outcome
Recovery Time (Rt[65] From Insulin-induced Hypoglycemia
Time frame: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes
Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes
4 secondary outcomes
Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893
Time frame: From time of MK0893 administration through 24 hours post-dose
Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893
Time frame: From time of MK0893 administration through estimated 32 hours post-dose
Number of Participants With An Adverse Event (AE)
Time frame: From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).
Number of Participants Who Discontinued Study Treatment Due To AEs
Time frame: From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- 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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK0893 and Propranolol Hydrochloride (HCL) 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 3 Jul 2015. 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. 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 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 8 May 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?
Recovery Time (Rt[65] From Insulin-induced Hypoglycemia (time frame: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes). 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 3 Jul 2015.