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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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