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)

NCT ID: NCT01590771

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 498 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-09
• Study Completion Date: 2014-06-24

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

Sitagliptin 100 mg oral tablet once daily for 24 weeks

Gliclazide

Intervention Type: DRUG

Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.

Glimepiride

Intervention Type: DRUG

Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.

Metformin

Intervention Type: DRUG

Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to sitagliptin oral tablet once daily for 24 weeks

Gliclazide

Intervention Type: DRUG

Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.

Glimepiride

Intervention Type: DRUG

Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.

Metformin

Intervention Type: DRUG

Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.

Interventions

Sitagliptin

Sitagliptin 100 mg oral tablet once daily for 24 weeks

Intervention Type: DRUG

Placebo

Matching placebo to sitagliptin oral tablet once daily for 24 weeks

Intervention Type: DRUG

Gliclazide

Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.

Intervention Type: DRUG

Glimepiride

Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.

Intervention Type: DRUG

Metformin

Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.

Intervention Type: DRUG

Other Intervention Names

Januvia®; MK-0431

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Ba J, Han P, Yuan G, Mo Z, Pan C, Wu F, Xu L, Hanson ME, Engel SS, Shankar RR. Randomized trial assessing the safety and efficacy of sitagliptin in Chinese patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea alone or combined with metformin. J Diabetes. 2017 Jul;9(7):667-676. doi: 10.1111/1753-0407.12456. Epub 2016 Sep 13.

Reference Type: RESULT

PMID: 27502307 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0431-253

Identifier Type: -

Identifier Source: org_study_id