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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: sitagliptin phosphate; Drug: Comparator: metformin; Drug: Comparator: Antidiabetic Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875394

0431-189

2009_571

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 30 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

1

Experimental group

Description:

sitagliptin + metformin

Treatment:

Drug: Comparator: metformin

Drug: sitagliptin phosphate

2

Active Comparator group

Description:

metformin + any other oral antidiabetic drug

Treatment:

Drug: Comparator: Antidiabetic Standard of Care

Drug: Comparator: metformin

3

Active Comparator group

Description:

metformin

Treatment:

Drug: Comparator: metformin