Study to Evaluate Safety and Efficacy of Dutogliptin in T... | NCT00958269 | Trialant

Study to Evaluate Safety and Efficacy of Dutogliptin in T... | NCT00958269 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dutogliptin (double-blind, placebo-controlled period)	Experimental	weeks 1-26	Drug: dutogliptin
dutogliptin (single-blind, active-controlled period)	Experimental	weeks 27-52	Drug: dutogliptin
placebo (double-blind, placebo-controlled period)	Placebo Comparator	weeks 1-26	Drug: placebo
placebo (single-blind, active-controlled period)	Placebo Comparator	weeks 27-52	Drug: placebo
sitagliptin (single-blind, active-controlled period)	Active Comparator	weeks 27-52	Drug: sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs		Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study)

Contacts/Locations Module

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases