Phase 2
Completed N=14
Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01915849 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose — 101.97; 93.89; 63.84; 97.76 (umol/kg FFM/min)*hr
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 doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose |
101.97; 93.89; 63.84; 97.76; 109.99; 117.81 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01915849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.