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

Status

Completed

Phase

Phase 3

Enrollment

480 participants (actual)

Sponsor

Merck Sharp & Dohme LLC · Industry

Design

Randomized · Double masking

Countries

Not stated

Start

16 Aug 2010

Primary completion

31 Oct 2012

Completion

31 Oct 2012

First posted

27 Aug 2010 (estimated)

Last update posted

5 Jun 2017

Conditions

Type 2 Diabetes Mellitus

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.

• Experimental

  Sitagliptin

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

• Active comparator

  Glimepiride

  Glimepiride 1-6 mg QD

1. Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30

   Time frame · Baseline and Week 30

   Registry description

   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.

2. Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30

   Time frame · Up to Week 30

   Registry description

   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.

3. Number of Participants Experiencing An Adverse Event (AE)

   Time frame · Up to Week 30

   Registry description

   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.

4. Number of Participants Discontinuing Study Treatment Due to An AE

   Time frame · Up to Week 30

   Registry description

   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.

No study cites this trial.