The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

Open-label, Non Placebo-Controlled Study To Verify the Effect of Sitagliptin In Adult Patients With Type 2 Diabetes and Inadequate Glycemic Control

to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus Non-insulin-dependent
• Intervention / Treatment: Drug: sitagliptin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

  • Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)
  • Or On A Single AHa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; sitagliptin	Drug: sitagliptin; Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks; Other Names: Januvia; MK0431

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18	Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.	Baseline and Week 18

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2008
• Primary Completion (Actual): September 2, 2009
• Study Completion (Actual): September 2, 2009

Study Registration Dates

• First Submitted: January 28, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (Estimate): January 30, 2009

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-118; 2009_526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php