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)

NCT ID: NCT00875394

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-01
• Study Completion Date: 2008-06-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

sitagliptin + metformin

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

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

Comparator: metformin

Intervention Type: DRUG

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

2

metformin + any other oral antidiabetic drug

Group Type: ACTIVE_COMPARATOR

Comparator: metformin

Intervention Type: DRUG

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

Comparator: Antidiabetic Standard of Care

Intervention Type: DRUG

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

3

metformin

Group Type: ACTIVE_COMPARATOR

Comparator: metformin

Intervention Type: DRUG

metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks

Interventions

sitagliptin phosphate

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

Intervention Type: DRUG

Comparator: metformin

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

Intervention Type: DRUG

Comparator: metformin

metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks

Intervention Type: DRUG

Comparator: Antidiabetic Standard of Care

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

Intervention Type: DRUG

Other Intervention Names

sitagliptin; metformin; metformin

Eligibility Criteria

Inclusion Criteria

• 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%

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2009_571

Identifier Type: -

Identifier Source: secondary_id

0431-189

Identifier Type: -

Identifier Source: org_study_id