A Dose-Range Finding Study in Patient With Type 2 Diabetes (MK-3102-006 EXT1)

Status:	Archived
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	October 2010
End Date:	July 2013

A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control

The purpose of this study is to assess the hypothesis that treatment with study medication
(MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity)
compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different
doses of MK-3102 to identify which dose is the most effective in the treatment of type 2
diabetes.

MK-3102-006-Ext 1 added a 66-week extension to the base study (MK-3102 P006) to assess the
long-term safety and tolerability of MK-3102. To be eligible for the extension,
participants must complete the double-blind base study, must have had at least a 75%
compliance with study drug during the base study and can not meet any of the criteria for
discontinuation. Participants randomized to placebo in the base study will be switched in a
blinded manner to pioglitazone 30 mg in the extension study. Participants randomized to
0.25 mg, 1 mg, 3 mg, and 10 mg of MK-3102 in the base study will be switched to MK-3102 25
mg; those randomized to 25 mg of MK-3102 in the base study will continue on the same dose
in the extension study. After the clinical dose of MK-3102 selected for further development
has been identified based upon the results of the base study, all participants randomized to
MK-3102 will be switched to the identified clinical dose.

We found this trial at

sites

Abington Memorial Hospital

1200 Old York Road
Abington, Pennsylvania 19001

(215) 481–2000