Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo to Glimepiride; Drug: Glimepiride; Drug: Placebo to Sitagliptin; Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189890

0431-251

Details and patient eligibility

About

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.

Full description

The dose of sitagliptin will be 100 mg once daily (QD) or 50 mg QD based on the participant's estimated glomerular filtration rate (eGFR). The starting dose of glimepiride (1 mg QD) may be up-titrated as needed to optimize glycemic control over the first 18 weeks to a maximum dose of 6 mg/day, after which the dose will not be increased for the rest of the study (down-titration to avoid or control hypoglycemia is allowed).

Enrollment: 480 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups

Sitagliptin

Experimental group

Description:

Sitagliptin phosphate 100 mg or 50 mg once daily (QD)

Treatment:

Drug: Placebo to Glimepiride

Drug: sitagliptin phosphate

Glimepiride

Active Comparator group

Description:

Glimepiride 1-6 mg QD

Treatment:

Drug: Placebo to Sitagliptin

Drug: Glimepiride