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Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01697592
First received: September 28, 2012
Last updated: September 29, 2015
Last verified: September 2015

September 28, 2012
September 29, 2015
October 2012
May 2014   (final data collection date for primary outcome measure)
  • Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
  • Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo→Omarigliptin group defined as the open-label extension period only.
  • Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
  • Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo→Omarigliptin group defined as the open-label extension period only.
  • 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 experienced at least one adverse event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01697592 on ClinicalTrials.gov Archive Site
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.
Change from baseline in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy
This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.
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: Omarigliptin
    Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
  • Drug: Matching placebo to omarigliptin
    Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
  • Experimental: Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)
    Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.
    Intervention: Drug: Omarigliptin
  • Experimental: Omarigliptin 25 mg/Glinides (Phase A+B)
    Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.
    Intervention: Drug: Omarigliptin
  • Experimental: Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)
    Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.
    Intervention: Drug: Omarigliptin
  • Experimental: Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)
    Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.
    Intervention: Drug: Omarigliptin
  • Experimental: Omarigliptin 25 mg/α-GIs (Phase A+B)
    Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.
    Intervention: Drug: Omarigliptin
  • Placebo Comparator: Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
    Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.
    Interventions:
    • Drug: Omarigliptin
    • Drug: Matching placebo to omarigliptin
  • Placebo Comparator: Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
    Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.
    Interventions:
    • Drug: Omarigliptin
    • Drug: Matching placebo to omarigliptin
  • Placebo Comparator: Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
    Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.
    Interventions:
    • Drug: Omarigliptin
    • Drug: Matching placebo to omarigliptin
  • Placebo Comparator: Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
    Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.
    Interventions:
    • Drug: Omarigliptin
    • Drug: Matching placebo to omarigliptin
  • Placebo Comparator: Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
    Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.
    Interventions:
    • Drug: Omarigliptin
    • Drug: Matching placebo to omarigliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
585
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01697592
3102-015, 132242
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2015

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