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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01698775
First received: October 1, 2012
Last updated: October 22, 2014
Last verified: October 2014

October 1, 2012
October 22, 2014
October 2012
November 2015   (final data collection date for primary outcome measure)
  • Change from baseline in glycosylated hemoglobin (A1C) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT01698775 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
  • Change from baseline in eGFR [ Time Frame: Baseline and Week 54 ] [ 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 ]
Not Provided
Not Provided
 
A Study of MK-3102 in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)
A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control

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. The primary hypothesis of the study is that MK-3102 compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
November 2015
November 2015   (final data collection date for primary outcome measure)

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 or with MK-3102 at any time prior to study participation
  • 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 been on a weight loss medication in the past 6 months, 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
Both
30 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Canada,   Serbia,   Australia,   Hong Kong,   Philippines,   Israel,   Croatia,   Russian Federation,   United Kingdom,   Spain,   Czech Republic,   Malaysia,   South Africa,   Hungary,   Poland
 
NCT01698775
3102-019, 2012-002332-85
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP