Status:
COMPLETED
Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily dos...
Eligibility Criteria
Inclusion
- Patients, age 18-65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
- Fasting plasma glucose ≤250mg/dL at screening.
- If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
Exclusion
- Patients with type 1 diabetes mellitus.
- Patients with history of acute diabetic complications within the 6 months prior to screening.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
- Patients with signs or symptoms of significant diabetic complications.
- Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01915849
Start Date
July 1 2013
End Date
January 1 2014
Last Update
February 6 2015
Active Locations (1)
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1
Novartis Investigative Site
Chula Vista, California, United States, 91910