A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01590771
First received: May 1, 2012
Last updated: April 16, 2015
Last verified: April 2015

May 1, 2012
April 16, 2015
July 2012
June 2014   (final data collection date for primary outcome measure)
  • Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
  • Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
  • Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Sulfonylurea Alone or in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01590771 on ClinicalTrials.gov Archive Site
  • Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
  • Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
  • Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
  • Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
  • Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
  • Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
  • Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
  • Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
  • Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone or in Combination with Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone or in Combination with Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Sulfonylurea in Combination wiht Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose Levels at Week 24 in Participants Receiving Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy, Alone or in Combination With Metformin

A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.

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: Sitagliptin
    Sitagliptin 100 mg oral tablet once daily for 24 weeks
    Other Names:
    • Januvia®
    • MK-0431
  • Drug: Placebo
    Matching placebo to sitagliptin oral tablet once daily for 24 weeks
  • Drug: Gliclazide
    Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
  • Drug: Glimepiride
    Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
  • Drug: Metformin
    Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
  • Experimental: Sitagliptin
    Sitagliptin 100 mg once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during run-in period.
    Interventions:
    • Drug: Sitagliptin
    • Drug: Gliclazide
    • Drug: Glimepiride
    • Drug: Metformin
  • Placebo Comparator: Placebo
    Matching placebo once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
    Interventions:
    • Drug: Placebo
    • Drug: Gliclazide
    • Drug: Glimepiride
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
498
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • has T2DM
  • is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks
  • has a Visit 1/Screening HbA1C between 7.5% and 11.0%
  • is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication

Exclusion Criteria:

  • has a history of type 1 diabetes mellitus or a history of ketoacidosis
  • has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever

been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue

  • has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin
  • is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
  • has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
  • has a medical history of active liver disease
  • has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
  • has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
  • has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
  • has human immunodeficiency virus (HIV)
  • has severe peripheral vascular disease
  • 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
  • has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • has a clinically important hematological disorder (such as aplastic anemia,

myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

  • is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
  • is a user of recreational or illicit drugs or has had a recent history of drug abuse
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
China
 
NCT01590771
0431-253
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2015

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