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) logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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