A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

Merck Sharp & Dohme LLC1,035 enrolled

Overview

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,035

Conditions

Type 2 Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus, Non-Insulin-Dependent

Interventions

sitagliptinDRUG

Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks

Comparator: glimepirideDRUG

glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.

open-label metforminDRUG

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older * Diagnosed with type 2 diabetes * On a stable dose of metformin of at least 1500 mg per day Exclusion Criteria: * History of type 1 diabetes * Pregnant * HIV positive * On a weight loss program or medication * Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Outcomes

Primary Outcomes

Change From Baseline in HbA1c at Week 30

Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.

Time frame: Week 0 to Week 30

Secondary Outcomes

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30

Change from baseline at Week 30 was defined as Week 30 minus Week 0.

Time frame: Week 0 to Week 30

Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30

Time frame: Week 0 to Week 30

Change From Baseline in Body Weight at Week 30

Change from baseline at Week 30 was defined as Week 30 minus Week 0.

Time frame: Week 0 to Week 30

Percent of Patients With A1C <7.0% at Week 30

Time frame: Week 30

Percent of Patients With A1C <6.5% at Week 30

Time frame: Week 30

Data from ClinicalTrials.gov

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