Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment

Phenomix

Status and phase: Terminated; Phase 3

Conditions: Renal Impairment; Type 2 Diabetes Mellitus

Treatments: Drug: sitagliptin; Drug: placebo; Drug: dutogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958269

PHX1149-PROT306

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Renal impairment (moderate and severe)
• Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
• HbA1c 7.0% - 10.5%, inclusive
• Male or female subjects between the ages of 18 and 85 years, inclusive.

Exclusion criteria

• Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
• Kidney transplant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 5 patient groups, including a placebo group

dutogliptin (double-blind, placebo-controlled period)

Experimental group

Description:

weeks 1-26

Treatment:

Drug: dutogliptin

Drug: dutogliptin

dutogliptin (single-blind, active-controlled period)

Experimental group

Description:

weeks 27-52

Treatment:

Drug: dutogliptin

Drug: dutogliptin

placebo (double-blind, placebo-controlled period)

Placebo Comparator group

Description:

weeks 1-26

Treatment:

Drug: placebo

placebo (single-blind, active-controlled period)

Placebo Comparator group

Description:

weeks 27-52

Treatment:

Drug: placebo

sitagliptin (single-blind, active-controlled period)

Active Comparator group

Description:

weeks 27-52

Treatment:

Drug: sitagliptin

Drug: sitagliptin