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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)

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ClinicalTrials.gov Identifier: NCT01590771
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : May 4, 2015
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Placebo Drug: Gliclazide Drug: Glimepiride Drug: Metformin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 9, 2012
Primary Completion Date : June 10, 2014
Study Completion Date : June 24, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: Sitagliptin
Sitagliptin 100 mg oral tablet once daily for 24 weeks
Other Names:
  • Januvia®
  • MK-0431
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.
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.

  2. Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to 26 weeks ]
    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.

  3. Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.

  2. 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 ]
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.

  3. 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 ]
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.

  4. Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ]
    A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.

  5. 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 ]
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.

  6. Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ]
    This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.

  7. 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 ]
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.

  8. Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ]
    This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01590771     History of Changes
Other Study ID Numbers: 0431-253
First Posted: May 3, 2012    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Sitagliptin Phosphate
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors