Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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 doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).
Key facts
- Study ID
- NCT01915849
- Run by
- Novartis Pharmaceuticals
- People needed
- 14
- Starts
- 2013-07-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2015-02-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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