Sitagliptin Added-on to Insulin Study (0431-051)

NCT00395343 | Completed Phase 3 Results

• 3 other identifiers: 0431-051MK0431-0512006_532
• Study Type: interventional
• Target: 641
• Locations: 0 countries
• Sites: N/A

Brief Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in A1C at Week 24

  A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

  Baseline and Week 24

Secondary Outcomes (5)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

• Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24

  Baseline and Week 24

• Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24

  Baseline and Week 24

• Percent of Patients With A1C < 7.0% at Week 24

  24 Weeks

• Percent of Patients With A1C < 6.5% at Week 24

  Week 24

Other Outcomes (1)

• Change From Baseline in A1C at Week 24

  Baseline and Week 24

Study Arms (2)

1

EXPERIMENTAL

sitagliptin

Drug: sitagliptin phosphate

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator : placebo (unspecified)

Interventions

sitagliptin phosphate DRUG

sitagliptin 100 mg tablet qd for a 24-wk treatment period.

Also known as: MK0431, Januvia™

1

Comparator : placebo (unspecified) DRUG

sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has type 2 diabetes mellitus
• Patient is poorly controlled while on insulin or insulin and metformin

You may not qualify if:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient is taking oral antidiabetic agents other than metformin during the past 3 months
• Patient is currently on treatment with daily use of pre-prandial short-acting or rapid-acting insulin

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Vilsboll T, Rosenstock J, Yki-Jarvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x.

  PMID: 20092585 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

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 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: November 1, 2006
• First Posted: November 2, 2006
• Study Start: December 11, 2006
• Primary Completion: October 13, 2008
• Study Completion: October 13, 2008
• Last Updated: May 12, 2017
• Results First Posted: October 23, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share