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

NCT00832624 | Terminated Phase 4 Results

• 2 other identifiers: 0431-1182009_526
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus Non-insulin-dependent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

sitagliptin

Drug: sitagliptin

Interventions

sitagliptin DRUG

Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks

Also known as: Januvia, MK0431

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

The planned 18-week study was terminated early due to reconsideration of the study design. None of the 10 patients progressed beyond the second study visit, no laboratory tests were performed, and adverse experience data were not collected.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: November 26, 2008
• Primary Completion: September 2, 2009
• Study Completion: September 2, 2009
• Last Updated: May 23, 2017
• Results First Posted: October 11, 2010

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share