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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014