A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000019-27-DK

Enrollment

1034

Registered

2007-02-20

Start date

2007-03-13

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Product Name: sitagliptin phosphate Product Code: MK-0431 Pharmaceutical Form: Tablet INN or Proposed INN: Sitagliptin phospate Current Sponsor code: MK-0431 Concentration unit: mg milligram(s) Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Patient has type 2 diabetes mellitus and glycemic control has not responded to diet and exercise. b. Patient has an HbA1c =6.5% and =9.0%. c. Patient is =18 and =78 years of age on the day of signing informed consent. d. Patient has not been on an antihyperglycemic medication for at least 4 months (16 weeks). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. b. Hypersensitivity or contraindication to biguanide medication (i.e., metformin).

Design outcomes

Primary

Measure	Time frame
Main Objective: Objective: To assess the HbA1c-lowering efficacy of sitagliptin compared to metformin after 24 weeks of treatment. Objective: To assess the safety and tolerability of sitagliptin over 24 weeks of treatment. ;Secondary Objective: Objective: To assess the gastrointestinal tolerance (based upon the incidence of selected predefined GI adverse experiences) of sitagliptin compared to metformin over 24 weeks of treatment. ;Primary end point(s): Change from baseline in HbA1c at Week 24	—

Measure

Time frame

Main Objective: Objective: To assess the HbA1c-lowering efficacy of sitagliptin compared to metformin after 24 weeks of treatment. Objective: To assess the safety and tolerability of sitagliptin over 24 weeks of treatment. ;Secondary Objective: Objective: To assess the gastrointestinal tolerance (based upon the incidence of selected predefined GI adverse experiences) of sitagliptin compared to metformin over 24 weeks of treatment. ;Primary end point(s): Change from baseline in HbA1c at Week 24

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Countries

Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Hungary, Ireland, Lithuania, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026