Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

NCT00875394 | Completed Phase 3 Results

• 2 other identifiers: 0431-1892009_571
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24

  Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

  Baseline and 24 weeks

Study Arms (3)

1

EXPERIMENTAL

sitagliptin + metformin

Drug: sitagliptin phosphate; Drug: Comparator: metformin

2

ACTIVE COMPARATOR

metformin + any other oral antidiabetic drug

Drug: Comparator: metformin; Drug: Comparator: Antidiabetic Standard of Care

3

ACTIVE COMPARATOR

metformin

Drug: Comparator: metformin

Interventions

sitagliptin phosphate DRUG

sitagliptin 100 mg Once a day (QD) for 24 weeks

Also known as: sitagliptin

1

Comparator: metformin DRUG

metformin 850 mg Twice a day (BID) for 24 weeks

Also known as: metformin

1; 2

Comparator: Antidiabetic Standard of Care DRUG

Patient can take any oral antidiabetic drug (other than metformin)

2

Eligibility Criteria

• Age: 30 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
• Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
• Patient Is Currently On Metformin Therapy (1500 Mg/Day)
• Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With \>2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
• Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
• Patient Has An A1c of 6.5 % - 11.0%

You may not qualify if:

• Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin

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; Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

A limited number of participants were recruited into this open-label study. This study was conducted at a single site. Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 3, 2009
• Study Start: February 1, 2007
• Primary Completion: June 27, 2008
• Study Completion: June 27, 2008
• Last Updated: May 30, 2017
• Results First Posted: April 20, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share