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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin; Drug: LCQ908A; Drug: Placebo; Drug: metformin

• Registration Number: NCT00901979
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Last Update Submitted: 2013-01-03
• Disposition First Posted: 2013-01-04
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

Inclusion Criteria

• HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion Criteria

• CHF Class III-IV, Liver disease

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	metformin	-
Sitagliptin	Sitagliptin	-
Sitagliptin	metformin	-
LCQ908 Dose 1	metformin	-
LCQ908 Dose 2	LCQ908A	-
LCQ908 Dose 2	metformin	-
LCQ908 Dose 3	LCQ908A	-
LCQ908 Dose 4	LCQ908A	-
LCQ908 Dose 1	LCQ908A	-
LCQ908 Dose 5	LCQ908A	-
LCQ908 Dose 5	metformin	-
Placebo	Placebo	-
LCQ908 Dose 3	metformin	-
LCQ908 Dose 4	metformin	-

Primary Outcome Measures

Name	Time	Method
Effect of LCQ on measures of glucose control	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body weight and related measures	12 weeks
Insulin sensitivity	12 weeks
Safety and tolerability	12 weeks

Trial Locations

Locations (67)

Clinical Research Advantage; 🇺🇸 Mesa, Arizona, United States

Mesa Family Medical Center/Clinical Research Advantage; 🇺🇸 Mesa, Arizona, United States

Woodland International Reserach Group, LLC; 🇺🇸 Little Rock, Arkansas, United States

Associated Pharmaceutical Research; 🇺🇸 Buena Park, California, United States

John Muir Clinical Research; 🇺🇸 Concord, California, United States

*Private Practice*; 🇺🇸 Pasadena, California, United States

Apex Research of Riverside; 🇺🇸 Riverside, California, United States

California Research Foundation; 🇺🇸 San Diego, California, United States

CNRI-San Diego, LLC; 🇺🇸 San Diego, California, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

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