ALPHA Sitagliptin Add on to Metformin (0431-103)

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00833027
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-01
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-30
• Primary Completion: 2009-10-30
• Study Completion: 2009-10-30
• Results First Submitted: 2010-08-26
• Results First Submitted QC: 2010-08-26
• Results First Posted: 2010-09-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 608

Inclusion Criteria

Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	sitagliptin phosphate	Sitagliptin

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at Week 24	Baseline and Week 24	HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at Week 12	Baseline and Week 12	HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent