A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701090
• Other study ID #: 0431-803
• Secondary ID: 2008_503
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2008
• Last updated: March 23, 2015
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1035
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Diagnosed with type 2 diabetes

• On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

• History of type 1 diabetes

• Pregnant

• HIV positive

• On a weight loss program or medication

• Has a history of blood disorder, certain cancers, heart, liver or kidney disease

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, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus, Non Insulin Dependent.

Intervention

Drug:
• sitagliptin
Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
• Comparator: glimepiride
glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
• open-label metformin
open-label metformin oral tablets (=1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c at Week 30	Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.	Week 0 to Week 30	No
Secondary	Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30	Change from baseline at Week 30 was defined as Week 30 minus Week 0.	Week 0 to Week 30	No
Secondary	Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30		Week 0 to Week 30	No
Secondary	Change From Baseline in Body Weight at Week 30	Change from baseline at Week 30 was defined as Week 30 minus Week 0.	Week 0 to Week 30	No
Secondary	Percent of Patients With A1C <7.0% at Week 30		Week 30	No
Secondary	Percent of Patients With A1C <6.5% at Week 30		Week 30	No

External Links

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