A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus; Chronic Renal Insufficiency

Treatments: Drug: Omarigliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01407276

3102-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 8 patient groups

Part 1: Mild Renal Impairment (Panel A)

Experimental group

Treatment:

Drug: Omarigliptin

Part 1: Control to Match Panel A (Panel B)

Experimental group

Treatment:

Drug: Omarigliptin

Part 1: Moderate Renal Impairment (Panel C)

Experimental group

Treatment:

Drug: Omarigliptin

Part 1: Control to Match Panel C (Panel D)

Experimental group

Treatment:

Drug: Omarigliptin

Part 1: Severe Renal Impairment (Panel E)

Experimental group

Treatment:

Drug: Omarigliptin

Part 1: Control to Match Panel E (Panel F)

Experimental group

Treatment:

Drug: Omarigliptin

Part 2: End-stage Renal Disease needing hemodialysis (Panel G)

Experimental group

Treatment:

Drug: Omarigliptin

Part 2: Control to Match Panel G (Panel H)

Experimental group

Treatment:

Drug: Omarigliptin