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OpenTrials
Completed

NCT Number: NCT00901979

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Health Sciences Centre - Diabetes Research Group, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCQ908A

Drug

Placebo

Drug

Sitagliptin

Drug

metformin

Drug

Primary outcomes

  1. Effect of LCQ on measures of glucose control

    Time frame: 12 weeks

Secondary outcomes

  1. Changes in body weight and related measures

    Time frame: 12 weeks

  2. Insulin sensitivity

    Time frame: 12 weeks

  3. Safety and tolerability

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 14, 2009
Registry last updated
Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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