- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01590797
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
July 20, 2018 updated by: Merck Sharp & Dohme LLC
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 Insulin Therapy, Alone or in Combination With Metformin
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable insulin 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 insulin alone or in combination with metformin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
467
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- has T2DM
- is currently on a stable regimen of pre-mixed, intermediate-acting, or long-acting insulin at a dose of at least 12 U/day, either alone or in combination with metformin >=1500 mg/day 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 been treated with any antihyperglycemic therapies other than a protocol-required insulin (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
- is currently on treatment with daily use (one or more injections per day) of
pre-prandial short-acting or rapid-acting insulin
- has a history of 2 or more episodes of hypoglycemia resulting in seizure,
coma, or loss of consciousness, or has had recurrent episodes of hypoglycemia over the past 8 weeks
- has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, insulin, 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sitagliptin
Participants treated with sitagliptin 100 mg, once daily, for 24 weeks.
All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during the Placebo Run-in period.
|
Sitagliptin 100 mg once daily for 24 weeks
Other Names:
Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
At randomization, participants will be stratified according to their use of metformin (on or not on).
All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
|
Placebo Comparator: Placebo
Participants treated with placebo matching sitagliptin, once daily, for 24 weeks.
All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during the Placebo Run-in period.
|
Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
At randomization, participants will be stratified according to their use of metformin (on or not on).
All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
Matching placebo once daily for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin
Time Frame: Baseline and Week 24
|
Baseline and Week 24
|
|
Number of Participants With One or More Adverse Events
Time Frame: Up to Week 26
|
An adverse event (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.
|
Up to Week 26
|
Number of Participants Discontinuing Study Medication Due to an AE
Time Frame: Up to Week 24
|
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.
|
Up to Week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin
Time Frame: Baseline and Week 24
|
Baseline and Week 24
|
Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin
Time Frame: Baseline and Week 24
|
Baseline and Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2012
Primary Completion (Actual)
June 11, 2014
Study Completion (Actual)
June 25, 2014
Study Registration Dates
First Submitted
May 1, 2012
First Submitted That Met QC Criteria
May 2, 2012
First Posted (Estimate)
May 3, 2012
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
July 20, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Sitagliptin Phosphate
Other Study ID Numbers
- 0431-254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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