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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effect of LCQ on measures of glucose control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body weight and related measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Novartis ( 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
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014