Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

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 Glimepiride With or Without Metformin

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00947557

Enrollment

677

Registered

2009-07-28

Start date

2009-07-31

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 therapy of glimepiride with or without metformin.

Interventions

DRUGDutogliptin

Dutogliptin oral administration once daily on background of glimepiride with or without metformin

DRUGPlacebo

Placebo, oral administration once daily on background of glimepiride with or without metformin

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 on 3 or more oral antidiabetic drugs or insulin. * Type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c (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), Visit 8 (Week 26).

Secondary

Measure	Time frame
Fasting Plasma Glucose (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), Visit 8 (Week 26).

Countries

Belarus, Colombia, Hungary, India, Lithuania, Peru, Romania, United States

Outcome results

None listed

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