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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01915849
First received: August 1, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The purpose of the study is 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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: LIK066
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-blinded, Placebo-controlled, Crossover Trial to Assess the Effect of Orally Administered LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Area under the postprandial curve (AUC) for rate of appearance (Ra) of exogenous glucose [ Time Frame: Day 1 and Day 4 ] [ Designated as safety issue: No ]
    The effect of single dose (day 1) and multiple doses (day 4) will be assessed


Enrollment: 14
Study Start Date: July 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIK066 Dose 1/Placebo/LIK066 Dose 2/LIK066 Dose 3
Period 1- LIK066 Dose 1 treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 Dose 2 treatment once daily (q.d.) for 4 days. Period 4- LIK066 Dose 3 treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Drug: LIK066 Drug: Placebo
Experimental: LIK066 Dose 2/LIK066 Dose 1/LIK066 Dose 3/Placebo
Period 1- LIK066 Dose 2 treatment once daily (q.d.) for 4 days. Period 2- LIK066 Dose 1 treatment once daily (q.d.) for 4 days. Period 3 - LIK066 Dose 3 treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days . 14 days washout periods between treatment periods.
Drug: LIK066 Drug: Placebo
Experimental: LIK066 Dose 3/ LIK066 Dose 2/Placebo/LIK066 Dose 1
Period 1- LIK066 Dose 3 treatment once daily (q.d.) for 4 days. Period 2- LIK066 Dose 2 treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 Dose 1 treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Drug: LIK066 Drug: Placebo
Experimental: Placebo/LIK066 Dose 3/LIK066 Dose 1/LIK066 Dose 2
Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 Dose 3 treatment once daily (q.d.) for 4 days. Period 3- LIK066 Dose 1 treatment once daily (q.d.) for 4 days. Period 4- LIK066 Dose 2 treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Drug: LIK066 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915849

Locations
United States, California
Novartis Investigative Site
Chula Vista, California, United States, 91910
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01915849     History of Changes
Other Study ID Numbers: CLIK066A2201
Study First Received: August 1, 2013
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014