Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and a PPARg Agonist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350779
• Other study ID #: 0431-052
• Secondary ID: MK0431-0522006_5
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2006
• Last updated: February 3, 2016
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Patient is inadequately controlled while taking two oral antidiabetic medications

Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

• Patient required insulin therapy within the prior 3 months

• Patient has been taking Byetta (R) (exenatide) within the prior 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin
Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period.
• Comparator: Placebo
Placebo to sitagliptin 100mg tablet each day for 54 weeks.
• rosiglitazone
Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
• metformin
Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
• glipizide
Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.	Baseline and 18 Weeks	No
Secondary	Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18	Change from baseline at Week 18 is defined as Week 18 minus Week 0	Baseline and 18 Weeks	No
Secondary	Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18	Change from baseline at Week 18 is defined as Week 18 minus Week 0	Baseline and Week 18	No
Secondary	Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.	Baseline and Week 54	No
Secondary	Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54	Change from baseline at Week 54 is defined as Week 54 minus Week 0	Baseline and Week 54	No
Secondary	Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54	Change from baseline at Week 54 is defined as Week 54 minus Week 0.	Baseline and Week 54	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site