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Completed

NCT Number: NCT01590771

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 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

Sitagliptin 100 mg oral tablet once daily for 24 weeks

Other names: Januvia®, MK-0431

Placebo

Drug

Matching placebo to sitagliptin oral tablet once daily for 24 weeks

Gliclazide

Drug

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

Glimepiride

Drug

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

metformin

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 3, 2012
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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