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Type 2 Diabetes (T2D)Phase 1NCT01088711

Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)

A Phase 1 study testing Omarigliptin in people with Type 2 Diabetes (T2D), run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation. Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes (T2D)
What is being tested?
Omarigliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
No sites listed yet
Study dates
11 Mar 2010to 11 May 2010
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 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • obese (body mass index [BMI] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
  • has been diagnosed with T2D (Panel B)
  • is not actively participating in a weight loss program

Who cannot join

  • has a history of clinically-significant disease (other than T2D)
  • has a history of cancer
  • has estimated creatinine clearance ≤60 mL/min
  • is unable to refrain from or anticipates the use of any prescription or non-prescription medication
  • consumes excessive amounts of alcohol or caffeine
  • has participated in a previous omarigliptin study

About this study

Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes

This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.

Being tested
Omarigliptin, Placebo
Keywords
Type 2 diabetes (T2D)
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.

  • OmarigliptinDrug

    Also called MK-3102

    Once-weekly 50 mg capsule

  • PlaceboDrug

    Once-weekly placebo capsule

Study groups in NCT01088711
Study groupRoleWhat they receive
Healthy OmarigliptinExperimentalObese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A).
Receives: Drug: Omarigliptin
Healthy PlaceboPlacebo comparatorObese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A).
Receives: Drug: Placebo
T2D OmarigliptinExperimentalObese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).
Receives: Drug: Omarigliptin
T2D PlaceboPlacebo comparatorObese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing an Adverse Event (AE)

    Measured: Up to Day 36

  2. Number of Participants Withdrawing From Study Therapy Due to an AE

    Measured: Up to Day 22

Secondary outcomes (5)

  1. Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15

    Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.

    Measured: 168 hours post-dose on Day 15

  2. Percent Inhibition of DPP-4 After Day 22

    Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.

    Measured: 168 hours post dose on Day 22

  3. WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration

    Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.

    Measured: Through 4 hours post dose on Day 21

  4. WAA Total GLP-1 Concentration

    WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.

    Measured: Through 4 hours post dose on Day 21

  5. Plasma Glucose Concentration

    Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.

    Measured: Through 4 hours post dose on Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2010 (estimated)
  2. Study start11 Mar 2010
  3. Primary completion11 May 2010
  4. Study completion11 May 2010

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01088711
Sponsor's protocol ID
3102-004
Status last verified
Aug 2018
First submitted
16 Mar 2010
Last updated
10 Sep 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Addy C, Tatosian D, Glasgow XS, Gendrano IN 3rd, Kauh E, Martucci A, Johnson-Levonas AO, Selverian D, Matthews CZ, Gutierrez M, Wagner JA, Aubrey Stoch S. Pharmacokinetic and Pharmacodynamic Effects of Multiple-dose Administration of Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor, in Obese Participants With and Without Type 2 Diabetes Mellitus. Clin Ther. 2016 Mar;38(3):516-30. doi: 10.1016/j.clinthera.2015.12.020. Epub 2016 Feb 9.

    PubMed 26869191

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omarigliptin in people with Type 2 Diabetes (T2D), 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 3 inclusion and 6 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. 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 24 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?

Number of Participants Experiencing an Adverse Event (AE) (time frame: Up to Day 36). 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?

On the ClinicalTrials.gov record for NCT01088711, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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