An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00130806
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.

Detailed Description

The duration of treatment is 30 weeks.

Study Timeline

• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-16
• Study Start: 2005-09
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.)

Exclusion Criteria

• People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The difference in daily dose requirements of insulin after 24 weeks

Secondary Outcome Measures

Name	Time	Method
(a) HbA1C; (b) FPG; (c) Percent of patients with HbA1C <7.0%; (d) TG, HDL-C, non-HDL-C and apolipoprotein B; (e) Free Fatty Acids (FFA); (f) the incidence of hypoglycemic events at 24 weeks