A Study to Assess the Safety and Efficacy of MK-3102 in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to assess the safety and efficacy of MK-3102, dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and exercise. The primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C).
ConditionType 2 Diabetes Mellitus
InterventionDrug: MK-3102
Drug: Placebo to MK-3012
Drug: Metformin
Drug: Placebo to metformin
Drug: Glimepiride
PhasePhase 3
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT01717313
First ReceivedOctober 26, 2012
Last UpdatedApril 21, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateOctober 26, 2012
Last Updated DateApril 21, 2014
Start DateDecember 2012
Estimated Primary Completion DateApril 2015
Current Primary Outcome Measures
  • Change from baseline in hemoglobin A1c (A1C) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]
  • Percentage of participants who experienced at least one adverse event [Time Frame: Up to 24 weeks] [Designated as safety issue: Yes]
  • Percentage of participants who discontinued from the study due to an adverse event [Time Frame: Up to 24 weeks] [Designated as safety issue: Yes]
  • Percentage of participants who experienced at least one adverse event [Time Frame: Up to 57 weeks] [Designated as safety issue: Yes]
  • Percentage of participants who discontinued from the study due to an adverse event [Time Frame: Up to 54 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Change from baseline in fasting plasma glucose (FPG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]
  • Percentage of participants who achieve an A1C goal of <7% (53 mmol/mol) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]
  • Percentage of participants who achieve an A1C goal of <7% at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]
  • Change from baseline in 2-hour post meal glucose (PMG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]
  • Change from baseline in A1C at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]
  • Change from baseline in FPG at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]
  • Percentage of participants who achieve an A1C goal of <6.5% (48 mmol/mol) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]
  • Percentage of participants who achieve an A1C goal of <6.5% at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study to Assess the Safety and Efficacy of MK-3102 in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
Official TitleA Multicenter, Phase III, Randomized, Placebo-controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Brief Summary
The purpose of this study is to assess the safety and efficacy of MK-3102, dosed once-weekly
in participants with T2DM who have inadequate glycemic control on diet and exercise. The
primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo
provides greater reduction in hemoglobin A1c (A1C).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: MK-3102
MK-3102 25 mg capsule administered orally once a week.
Drug: Placebo to MK-3012
Placebo to MK-3102 capsule administered orally once a week
Drug: Metformin
If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the MK-3102 treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.
Other Names:
  • Fortamet®
  • Glucophage®
  • Glucophage® XR
  • Glumetza®
  • Riomet®
  • Metgluco®
  • Glycoran®
Drug: Placebo to metformin
During Phase B of the study, participants in the MK-3102 treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).
Drug: Glimepiride
If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic therapy
Other Names:
Armaryl®
Study Arm (s)
  • Experimental: MK-3102
    MK-3102 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by MK-3102 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin may be initiated as glycemic rescue therapy in Phase A, and open-label glimepiride in Phase B.
  • Placebo Comparator: Placebo to MK-3102
    Placebo to MK-3102 administered orally once a week for 24 weeks (Phase A) followed by placebo to MK-3102 administered orally once a week plus metformin for an additional 30 weeks (Phase B). Open-label metformin can be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment300
Estimated Completion DateApril 2015
Estimated Primary Completion DateApril 2015
Eligibility Criteria
Inclusion Criteria:

- Has type 2 diabetes mellitus

- Participants in India must be ≤65 years of age

- Meets one of the following criteria: currently not on an antihyperglycemic agent
(AHA) for >= 12 weeks and has an A1C of >=7% and <=10% or on stable monotherapy or
low-dose combination therapy for > 12 weeks and has an A1C of >=6.5% and <=9%

- Participant is one of the following: male, female who is not of reproductive
potential, female of reproductive potential who agrees to remain abstinent from
heterosexual activity or use (or have their partner use) acceptable contraception to
prevent pregnancy during the study and for 21 days after the last dose of study drug

Exclusion Criteria:

- History of type 1 diabetes mellitus or a history of ketoacidosis

- Has been treated with: a thiazolidinedione (TZD) within 4 months of study
participation, a glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist or
dipeptidyl peptidase IV (DPP-4) inhibitor within 6 months of study participation,
insulin or sodium-glucose cotransporter inhibitor within 12 weeks of study
participation, MK-3102 at any time prior to study participation

- History of hypersensitivity to DPP-4 inhibitor

- History of intolerance, hypersensitivity or any contraindication to metformin and/or
glimepiride or other sulfonylurea

- Is on a weight loss program and not in the maintenance phase or has started a weight
loss medication in the past 6 months or has undergone bariatric surgery within 12
months prior to study participation

- Has undergone a surgical procedure within 4 weeks of study participation or has
planned major surgery during the study

- Is on or likely to require treatment for ≥14 consecutive days or repeated courses of
corticosteroids (inhaled, nasal and topical corticosteroids are permitted)

- Is currently being treated for hyperthyroidism or is on thyroid hormone therapy and
has not been on a stable dose for at least 6 weeks

- Is expecting to undergo hormonal therapy in preparation to donate eggs during the
study, including 21 days following the last dose of study drug

- History of active liver disease (other than non-alcoholic steatosis) including
chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic
gallbladder disease

- Human immunodeficiency virus (HIV)

- Has had new or worsening coronary heart disease or congestive heart failure within
the past 3 months, or has any of the following disorders within the past 3 months:
acute coronary syndrome, coronary artery intervention, stroke or transient ischemic
neurological disorder

- Has poorly controlled hypertension

- History of malignancy <=5 years prior to study participation, except for basal cell
or squamous cell skin cancer or in situ cervical cancer

- Hematological disorder (such as aplastic anemia, myeloproliferative or
myelodysplastic syndromes, thrombocytopenia)

- Pregnant or breastfeeding, or is expecting to conceive during the study, including 21
days following the last dose of study drug

- User of recreational or illicit drugs or has had a recent history of drug abuse

- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or
engages in binge drinking

- Has donated blood products or has had a phlebotomy within 8 weeks of study
participation, or intends to donate blood products during the study or has received,
or is anticipated to receive, blood products within 12 weeks of study participation
or during the study
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Toll Free Number
1-888-577-8839
Location CountriesUnited States, Bulgaria, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Philippines, Romania, Taiwan

Administrative Information[ + expand ][ + ]

NCT Number NCT01717313
Other Study ID Numbers3102-011
Has Data Monitoring CommitteeYes
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Director Merck Sharp & Dohme Corp.
Verification DateApril 2014

Locations[ + expand ][ + ]

Call For Information (Investigational Site 0001)
Oklahoma City, Oklahoma, United States, 73139
Contact: Toll Free Number | 888-577-8839
Recruiting
Merck Sharp & Dohme Bulgaria EOOD
Sofia, Bulgaria
Contact: Eran Gefen | 38 (044) 393 74 80
Recruiting
Merck Sharp & Dohme GmbH
Haar, Germany
Contact: German Medical Information Center | 49 800 673 673 673
Recruiting
MSD Pharma Hungary Kft.
Budapest, Hungary
Contact: Simona Martinkova | 36 1 457 8522
Recruiting
MSD Italia S.r.l.
Rome, Italy
Contact: Patrizia Nardini | 39 06 361911
Recruiting
MSD Korea LTD
Seoul, Korea, Republic of
Contact: Cem Ozesen | 90 212 3361260
Recruiting
Merck Sharp & Dohme BV
Haarlem, Netherlands
Contact: Caroline Doornebos | 31 23 515 3362
Recruiting
Merck Sharp & Dohme (I.A.) Corporation
Makati, Philippines
Contact: Cesar Recto | 632 784 9500
Recruiting
Merck Sharp & Dohme Romania SRL
Bucharest, Romania
Contact: Eran Gefen | 38 (044) 393 74 80
Recruiting
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan
Contact: Diana Zhang | 886-2-66316030
Recruiting