- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189890
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
A Phase III, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus
Exclusion Criteria
- History of type 1 diabetes mellitus
- Has undergone a surgical procedure within the prior 4 weeks.
- Current participation in, or has participated, in another study with an investigational device or compound, with the prior 12 weeks, and/or is not willing to refrain from participating in any other study while participating in this study
- Hypersensitivity or contraindication to any sulfonylurea (e.g., glimepiride) medication
- Has been on an investigational or approved dipeptidyl peptidase-4 (DPP-4) inhibitor agent (e.g., sitagliptin, saxagliptin)
- Presence of human immunodeficiency virus (HIV)
- Current participation in a weight loss program or is receiving weight loss medication
- History of blood disorder, certain cancers, heart, liver or kidney disease
- Current or past use of recreational or illicit drugs, or a history of drug abuse or dependence, or increased alcohol consumption
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sitagliptin
Sitagliptin phosphate 100 mg or 50 mg once daily (QD)
|
Sitagliptin tablets, orally, at a dose of 100 mg or 50 mg QD for 30 weeks.
The dose level to be administered will depend on the participant's estimated glomerular filtration rate (eGFR), calculated at Visit 3 and may be adjusted as medically indicated during the study.
Other Names:
Matching placebo tablets to glimepiride to allow for blinding.
|
Active Comparator: Glimepiride
Glimepiride 1-6 mg QD
|
Glimepiride tablets, orally, starting at a dose of 1 mg QD, which may be gradually increased, as needed, to maximum dose of 6 mg QD for 30 weeks.
The dose may also be decreased as medically indicated during the study.
Other Names:
Matching placebo tablets to sitagliptin to allow for blinding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30
Time Frame: Baseline and Week 30
|
Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
|
Baseline and Week 30
|
Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30
Time Frame: Up to Week 30
|
Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level.
Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia.
If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL.
In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.
|
Up to Week 30
|
Number of Participants Experiencing An Adverse Event (AE)
Time Frame: Up to Week 30
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. |
Up to Week 30
|
Number of Participants Discontinuing Study Treatment Due to An AE
Time Frame: Up to Week 30
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. |
Up to Week 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
Time Frame: Baseline and Week 30
|
Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG.
|
Baseline and Week 30
|
Percentage of Participants With HbA1c <7.0% at Week 30
Time Frame: Week 30
|
Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
|
Week 30
|
Percentage of Participants With HbA1c <6.5% at Week 30
Time Frame: Week 30
|
Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30.
Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
|
Week 30
|
LS Mean Change From Baseline in Participant Body Weight at Week 30
Time Frame: Baseline and Week 30
|
Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation.
Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other.
Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30.
|
Baseline and Week 30
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
- Glimepiride
Other Study ID Numbers
- 0431-251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
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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