Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970424

Enrollment

252

Registered

2009-09-02

Start date

2009-08-31

Completion date

Unknown

Last updated

2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

Brief summary

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Interventions

DRUGPlacebo

placebo, oral tablet administered once daily on background of pioglitazone

DRUGDutogliptin

dutogliptin, oral tablet administered once daily on background of pioglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1) * BMI 20 to 48 kg/m2, inclusive * HbA1c 7.0% - 10.0%, inclusive * Age 18 to 85 years, inclusive

Exclusion criteria

* Currently taking more than one oral hypoglycemic agent * Type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c Level (HbA1c)	HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)

Secondary

Measure	Time frame
Fasting Plasma Glucose Level (FPG)	FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).

Countries

Belarus, Germany, India, Lithuania, Romania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026