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.
Verified April 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: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-3102
Drug: Placebo to MK-3102
Drug: Glipizide
Drug: Placebo to glipizide
Biological: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: October 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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: 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.
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).
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698775

Contacts
Contact: Toll Free Number 1-888-577-8839

  Hide Study Locations
Locations
United States, California
Call for Information (Investigational Site 0002) Recruiting
Chula Vista, California, United States, 91910
Call for Information (Investigational Site 0016) Recruiting
Roseville, California, United States, 95661
Call for Information (Investigational Site 0020) Recruiting
Sacramento, California, United States, 95825
Call for Information (Investigational Site 0021) Recruiting
Santa Monica, California, United States, 90404
Call for Information (Investigational Site 0015) Recruiting
West Hills, California, United States, 91307
United States, Florida
Call for Information (Investigational Site 0009) Recruiting
Doral, Florida, United States, 33172
Call for Information (Investigational Site 0022) Recruiting
Miami, Florida, United States, 33174
United States, Georgia
Call for Information (Investigational Site 0001) Recruiting
Macon, Georgia, United States, 31217
United States, Illinois
Call for Information (Investigational Site 0004) Recruiting
Chicago, Illinois, United States, 60612
United States, Maine
Call for Information (Investigational Site 0007) Recruiting
Rockport, Maine, United States, 04856
United States, New York
Call for Information (Investigational Site 0019) Recruiting
New Rochelle, New York, United States, 10801
United States, Tennessee
Call for Information (Investigational Site 0003) Recruiting
Chattanooga, Tennessee, United States, 37408
United States, Texas
Call for Information (Investigational Site 0010) Recruiting
Corpus Christi, Texas, United States, 78414
Call for Information (Investigational Site 0025) Recruiting
Houston, Texas, United States, 77043
Call for Information (Investigational Site 0013) Recruiting
Houston, Texas, United States, 77024
Call for Information (Investigational Site 0018) Recruiting
Houston, Texas, United States, 77074
Call for Information (Investigational Site 0011) Recruiting
Houston, Texas, United States, 77450
Call for Information (Investigational Site 0017) Recruiting
Sealy, Texas, United States, 77474
Call for Information (Investigational Site 0024) Recruiting
Sugar Land, Texas, United States, 77479
Call for Information (Investigational Site 0008) Recruiting
Temple, Texas, United States, 76502
United States, Washington
Call for Information (Investigational Site 0006) Recruiting
Federal Way, Washington, United States, 98003
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
Croatia
Merck Sharp & Dohme d.o.o Recruiting
Zagreb, Croatia
Contact: Andina Hrabar    385 14878400      
Czech Republic
Merck Sharp and Dohme s.r.o. Recruiting
Praha, Czech Republic
Contact: Simona Martinkova    420 233010213      
Hong Kong
Merck Sharp & Dohme (Asia) Ltd. Recruiting
Hong Kong, Hong Kong
Contact: Lai Hung Jen    886 2 2730 0030      
Hungary
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Simona Martinkova    36 1 457 8522      
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Ofer Sharon    972 9 9539310      
Malaysia
MSD Recruiting
Petaling Jaya, Malaysia
Contact: Boon Hock Yeoh    60 377181723      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Adam Czernik    48 22 4784324      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva    7 0959410000      
Serbia
Merck Sharp & Dohme Recruiting
Belgrade, Serbia
Contact: Eran Gefen    38 (044) 393 74 80      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01698775     History of Changes
Other Study ID Numbers: 3102-019, 2012-002332-85
Study First Received: October 1, 2012
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Glipizide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014