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

August 1, 2013
March 6, 2014
July 2013
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01915849 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Type 2 Diabetes Mellitus
  • Drug: LIK066
  • Drug: Placebo
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: LIK066
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
January 2014
January 2014   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01915849
CLIK066A2201
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP