A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00511667

Enrollment

Registered

2007-08-06

Start date

2007-05-31

Completion date

2008-04-30

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

Interventions

DRUGMK0941

MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

DRUGComparator: Placebo

Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Nonsmoking Male or Female (of non-child bearing potential) * Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents * Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

Exclusion criteria

* Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist * Subject is on 3 or more oral anti-diabetes medications * Subject has a history of type 1 diabetes * Subject has a diagnosis of glaucoma or is blind * Subject has had trauma to one or both eyes

Design outcomes

Primary

Measure	Time frame
Participants With Any Clinical Adverse Experience	Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
Participants Discontinued Because of Any Clinical Adverse Experience	Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Secondary

Measure	Time frame
Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

Participant flow

Participants by arm

Arm	Count
MK-0941 All participants receiving any dose of MK-0941	52
Placebo All participants receiving any dose of placebo	18
Total	70

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Other	2	1
Overall Study	Protocol Violation	1	1
Overall Study	Site terminated	6	1
Overall Study	Withdrawal by Subject	2	0

Baseline characteristics

Characteristic	MK-0941	Placebo	Total
Age, Customized 29 to 70 years	52 participants	18 participants	70 participants
Sex: Female, Male Female	23 Participants	10 Participants	33 Participants
Sex: Female, Male Male	29 Participants	8 Participants	37 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	27 / 52	11 / 18
serious Total, serious adverse events	0 / 52	0 / 18

Outcome results

Primary

Participants Discontinued Because of Any Clinical Adverse Experience

Time frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Arm	Measure	Group	Value (NUMBER)
MK-0941	Participants Discontinued Because of Any Clinical Adverse Experience	Hyperglycemia	1 participants
MK-0941	Participants Discontinued Because of Any Clinical Adverse Experience	All other adverse experiences	0 participants
Placebo	Participants Discontinued Because of Any Clinical Adverse Experience	Hyperglycemia	0 participants
Placebo	Participants Discontinued Because of Any Clinical Adverse Experience	All other adverse experiences	0 participants

Primary

Participants With Any Clinical Adverse Experience

Time frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Arm	Measure	Value (NUMBER)
MK-0941	Participants With Any Clinical Adverse Experience	51.9 percentage of of participants
Placebo	Participants With Any Clinical Adverse Experience	61.1 percentage of of participants

Secondary