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) - Full Text View

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.

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:

MedlinePlus related topics: Chronic Kidney Disease Diabetes Diabetes Medicines Diabetes Type 2 Dialysis Kidney Failure

Drug Information available for: Insulin human Glipizide

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 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 ]

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.

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
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

Contacts and Locations

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information (Investigational Site 0016)	Recruiting
Roseville, California, United States, 95661
United States, Florida
Call for Information (Investigational Site 0009)	Recruiting
Doral, Florida, United States, 33172
United States, Illinois
Call for Information (Investigational Site 0004)	Recruiting
Chicago, Illinois, United States, 60612
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 0011)	Recruiting
Houston, Texas, United States, 77450
Call for Information (Investigational Site 0013)	Recruiting
Houston, Texas, United States, 77024
United States, Washington
Call for Information (Investigational Site 0006)	Recruiting
Federal Way, Washington, United States, 98003
Canada, Quebec
Merck Frosst Canada	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Mauricio Ede 1-514-428-3044
Hungary
MSD Pharma Hungary Kft.	Recruiting
Budapest, Hungary
Contact: Simona Martinkova 36 1 457 8522
Poland
MSD Polska Sp. Z o.o.	Recruiting
Warsaw, Poland
Contact: Adam Czernik 48 22 4784324
Serbia
Merck Sharp & Dohme	Recruiting
Belgrade, Serbia
Contact: Eran Gefen 38 (044) 393 74 80

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01698775 History of Changes
Other Study ID Numbers:	3102-019, 2012-002332-85
Study First Received:	October 1, 2012
Last Updated:	May 16, 2013
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 May 23, 2013