A Study of MK-3102 in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019 AM3)

• Percentage of participants who experienced at least one adverse event [ Time Frame: Baseline to Week 24 (up to 24 weeks) ] [ Designated as safety issue: Yes ]
• Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Baseline to Week 24 (up to 24 weeks) ] [ Designated as safety issue: Yes ]
• Percentage of participants who experienced at least one adverse event [ Time Frame: Baseline up to 28 days following the last dose of study therapy (up to 58 weeks) ] [ Designated as safety issue: Yes ]
• Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Baseline to Week 54 (up to 54 weeks) ] [ Designated as safety issue: Yes ]

• Number of participants who experienced at least one adverse event [ Time Frame: Baseline to Week 24 (up to 24 weeks) ] [ Designated as safety issue: Yes ]
• Number of participants who discontinued from the study due to an adverse event [ Time Frame: Baseline to Week 24 (up to 24 weeks) ] [ Designated as safety issue: Yes ]
• Number of participants who experienced at least one adverse event [ Time Frame: Baseline up to 28 days following the last dose of study therapy (up to 58 weeks) ] [ Designated as safety issue: Yes ]
• Number of participants who discontinued from the study due to an adverse event [ Time Frame: Baseline to Week 54 (up to 54 weeks) ] [ Designated as safety issue: Yes ]

• Change from baseline in glycosylated hemoglobin (A1C) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
• Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
• Change from baseline in A1C [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
• Change from baseline in FPG [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the efficacy and safety of MK-3102 in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control.

• Drug: MK-3102
  Participants with moderate renal insufficiency will receive one MK-3102 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one MK-3102 12.5 mg capsule orally once a week
• Drug: Placebo to MK-3102
  Matching placebo to MK-3102 capsule administered orally once a week
• Drug: Glipizide
  Participants may receive open-label glipizide as rescue therapy during Phase A (up to Week 24) of the study. During Phase B of the study (after Week 24), participants who did not receive insulin or open-label glipizide rescue therapy during Phase A will receive glipizide 2.5 mg or 5 mg capsule or matching placebo as blinded therapy at a starting dose of 2.5 mg once daily in the morning prior to the morning meal and electively titrated up to a maximum of 20 mg/day based on glycemic control.
  Other Names:

  • Glucotrol
  • Glucotrol XL
• Drug: Placebo to glipizide
  Matching placebo to glipizide
• Biological: Insulin
  Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.

• Experimental: MK-3102
  MK-3102 12.5 mg or 25 mg capsule orally once a week for 54 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24), will receive matching placebo to glipizide in a blinded manner during Phase B of the study (Week 24 through Week 54).
  Interventions:

  • Drug: MK-3102
  • Drug: Glipizide
  • Drug: Placebo to glipizide
  • Biological: Insulin
• Placebo Comparator: Placebo to MK-3102
  Matching placebo to MK-3102 orally once a week for 54 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24), will receive glipizide in a blinded manner during Phase B of the study (Week 24 through Week 54).
  Interventions:

  • Drug: Placebo to MK-3102
  • Drug: Glipizide
  • Drug: Placebo to glipizide
  • Biological: Insulin

Inclusion Criteria:

• Type 2 diabetes mellitus and be at least 30 years of age
• Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis

• Meet one of the following criteria:

  1. is currently not on an antihyperglycemic agent (AHA) and has A1C >=7% and <=10% at screening
  2. is currently on a single oral AHA or low-dose dual oral combination AHA and has A1C >=6.5% and <=9% at screening
  3. is currently on a stable insulin regimen (>= 15 U/day) for >= 10 weeks, with no oral AHA, and has A1C >=7.5% and <=10% and FPG >130 mg/dL at screening
• (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 28 days after the last dose of study drug

Exclusion Criteria:

• History of type 1 diabetes mellitus or a history of ketoacidosis
• Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to screening
• History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
• History of intolerance or hypersensitivity to glipizide or insulin glargine or any contraindication to glipizide or insulin glargine
• On a weight loss program and is not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to study participation
• Undergone a surgical procedure within 4 weeks prior to screening or has planned major surgery during the trial
• On or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal or topical corticosteroids are permitted)
• Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
• If on dialysis, does not regularly adhere to dialysis schedule
• Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class IV
• Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
• Human immunodeficiency virus (HIV)
• New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months
• Poorly controlled hypertension
• Severe active peripheral vascular disease
• History of malignancy <=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
• Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
• Positive pregnancy test
• Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 28 days following the last dose of study drug
• User of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking