Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: LIK066; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01915849

CLIK066A2201

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

14 participants in 4 patient groups

Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg

Experimental group

Description:

Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.

Treatment:

Drug: Placebo

Drug: LIK066

Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo

Experimental group

Description:

Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.

Treatment:

Drug: Placebo

Drug: LIK066

Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg

Experimental group

Description:

Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.

Treatment:

Drug: Placebo

Drug: LIK066

Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg

Experimental group

Description:

Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.

Treatment:

Drug: Placebo

Drug: LIK066