Phase 3
Completed N=480
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
Source: ClinicalTrials.gov NCT01189890 ↗Enrolled (actual)
480
Serious AEs
2.7%
Results posted
Jun 2013
Primary outcomePrimary: Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 — -0.32; -0.51 Percentage of HbA1c
Summary
The primary objectives of this study are to determine if sitagliptin treatment is not inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C) after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will be randomized to either sitagliptin or glimepiride treatment after eligibility for study participation is determined during screening and washout study phases. Participants and study staff will not know to which treatment group they have been randomized (double-blind design). The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3) oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of treatment with study medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 |
-0.32; -0.51 | — |
| PRIMARY Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 |
2; 11 | 0.009 sig |
| PRIMARY Number of Participants Experiencing An Adverse Event (AE) |
118; 115 | — |
| PRIMARY Number of Participants Discontinuing Study Treatment Due to An AE |
3; 4 | — |
| SECONDARY LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 |
-14.5; -21.2 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0% at Week 30 |
33.5; 46.6 | — |
| SECONDARY Percentage of Participants With HbA1c <6.5% at Week 30 |
9.1; 20.9 | — |
| SECONDARY LS Mean Change From Baseline in Participant Body Weight at Week 30 |
0.4; 1.1 | 0.011 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01189890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.