Status:
COMPLETED
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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-31...
Detailed 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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01407276
Start Date
August 8 2011
End Date
March 23 2012
Last Update
September 10 2018
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