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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901979
First Posted: May 14, 2009
Last Update Posted: January 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess the effect of LCQ when added to metformin.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: LCQ908A Drug: Placebo Drug: Sitagliptin Drug: metformin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Effect of LCQ on measures of glucose control [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Changes in body weight and related measures [ Time Frame: 12 weeks ]
  • Insulin sensitivity [ Time Frame: 12 weeks ]
  • Safety and tolerability [ Time Frame: 12 weeks ]

Enrollment: 693
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCQ908 Dose 1 Drug: LCQ908A Drug: metformin
Experimental: LCQ908 Dose 2 Drug: LCQ908A Drug: metformin
Experimental: LCQ908 Dose 3 Drug: LCQ908A Drug: metformin
Experimental: LCQ908 Dose 4 Drug: LCQ908A Drug: metformin
Experimental: LCQ908 Dose 5 Drug: LCQ908A Drug: metformin
Placebo Comparator: Placebo Drug: Placebo Drug: metformin
Active Comparator: Sitagliptin Drug: Sitagliptin Drug: metformin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901979


  Show 67 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00901979     History of Changes
Other Study ID Numbers: CLCQ908A2203
First Submitted: May 13, 2009
First Posted: May 14, 2009
Last Update Posted: January 9, 2013
Last Verified: January 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action