Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC190 enrolled

Overview

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayDRUG

Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayDRUG

Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has type 2 diabetes mellitus * Males * Females who are highly unlikely to become pregnant * Patients poorly controlled while taking one or two oral antidiabetic medications Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacidosis * Patient required insulin therapy within the prior 8 weeks * Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit

Outcomes

Primary Outcomes

Change From Baseline in A1C at Week 18

A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Time frame: Baseline and Week 18

Secondary Outcomes

Change From Baseline in FPG at Week 18

Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.

Time frame: Baseline and Week 18

Change From Baseline in 2 Hr-PMG at Week 18

Change from baseline at Week 18 is defined as Week 18 minus Week 0.

Time frame: Baseline and Week 18

Change From Baseline in A1C at Week 30

A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.

Time frame: Baseline and Week 30

Data from ClinicalTrials.gov

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