Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

NCT00449930 | Completed Phase 3 Results

• 3 other identifiers: 0431-049MK0431-0492006_561
• Study Type: interventional
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

  HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

  Baseline and 24 weeks

Secondary Outcomes (4)

• Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea

  Baseline to Week 24

• Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea

  Baseline to Week 24

• Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain

  Baseline to Week 24

• Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting

  Baseline to Week 24

Study Arms (2)

1

EXPERIMENTAL

Drug

Drug: sitagliptin phosphate

2

ACTIVE COMPARATOR

Active comparator

Drug: Comparator: metformin hydrochloride

Interventions

sitagliptin phosphate DRUG

(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period

Also known as: MK0431

1

Comparator: metformin hydrochloride DRUG

(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

2

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has type 2 diabetes mellitus (T2DM)
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

You may not qualify if:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, Goldstein BJ; Sitagliptin Study 049 Group. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Mar;12(3):252-61. doi: 10.1111/j.1463-1326.2009.01187.x. Epub 2009 Nov 25.

  PMID: 20070351 RESULT

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

Site 0490125 was non-compliant with Good Clinical Practice (GCP). Data from the 8 patients at this site were removed from all analyses.

Results Point of Contact

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 21, 2007
• Study Start: March 1, 2007
• Primary Completion: July 25, 2008
• Study Completion: July 25, 2008
• Last Updated: May 11, 2017
• Results First Posted: August 11, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share