Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

Merck Sharp & Dohme LLC211 enrolled

Overview

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

211

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Comparator: sitagliptin phosphateDRUG

sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.

Comparator: pioglitazoneDRUG

pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Comparator: placebo to pioglitazoneDRUG

pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has type 2 diabetes mellitus * Male * Female that is highly unlikely to become pregnant * Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%) Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis * Patient has required insulin therapy within the past 12 weeks * Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones \[TZDs\]) within the prior 12 weeks of the screening visit.

Outcomes

Primary Outcomes

Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment

Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.

Time frame: Baseline and 12 weeks

Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment

Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment

Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

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