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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00901979
First received: May 13, 2009
Last updated: January 3, 2013
Last verified: January 2013
  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: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 13, 2009
Last Updated: January 3, 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

ClinicalTrials.gov processed this record on May 25, 2017