A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00901979

Enrollment

693

Registered

2009-05-14

Start date

2009-04-30

Completion date

2010-06-30

Last updated

2013-01-09

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes

Brief summary

This study will assess the effect of LCQ when added to metformin.

Interventions

DRUGLCQ908A

DRUGPlacebo

DRUGSitagliptin

DRUGmetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion criteria

* CHF Class III-IV, Liver disease Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Effect of LCQ on measures of glucose control	12 weeks

Secondary

Measure	Time frame
Changes in body weight and related measures	12 weeks
Insulin sensitivity	12 weeks
Safety and tolerability	12 weeks

Countries

Canada, Italy, Poland, Puerto Rico, United States

Outcome results

None listed

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