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

Novartis

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: metformin; Drug: Sitagliptin; Drug: LCQ908A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00901979

CLCQ908A2203

Details and patient eligibility

About

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

Enrollment: 693 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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693 participants in 7 patient groups, including a placebo group

LCQ908 Dose 1

Experimental group

Treatment:

Drug: metformin

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

LCQ908 Dose 2

Experimental group

Treatment:

Drug: metformin

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

LCQ908 Dose 3

Experimental group

Treatment:

Drug: metformin

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

LCQ908 Dose 4

Experimental group

Treatment:

Drug: metformin

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

LCQ908 Dose 5

Experimental group

Treatment:

Drug: metformin

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Drug: LCQ908A

Placebo

Placebo Comparator group

Treatment:

Drug: metformin

Drug: Placebo

Sitagliptin

Active Comparator group

Treatment:

Drug: metformin

Drug: Sitagliptin