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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


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
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