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

• ClinicalTrials.gov Identifier: NCT01915849
• Recruitment Status: Completed
• First Posted: August 5, 2013
• Results First Posted: February 6, 2015
• Last Update Posted: February 6, 2015
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: August 1, 2013
• First Posted Date: August 5, 2013
• Results First Submitted Date: January 22, 2015
• Results First Posted Date: February 6, 2015
• Last Update Posted Date: February 6, 2015
• Study Start Date: July 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2015)

Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose [ Time Frame: Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4) ]

Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.

Original Primary Outcome Measures (submitted: August 1, 2013)

Area under the postprandial curve (AUC) for rate of appearance (Ra) of exogenous glucose [ Time Frame: Day 1 and Day 4 ]

The effect of single dose (day 1) and multiple doses (day 4) will be assessed

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
• 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
• Brief Summary: 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Type 2 Diabetes Mellitus

Intervention

• Drug: LIK066
  LIK066 15 mg, 50 mg and 150 mg
• Drug: Placebo

Study Arms

• Experimental: Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg
  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.
  Interventions:

  • Drug: LIK066
  • Drug: Placebo
• Experimental: Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo
  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.
  Interventions:

  • Drug: LIK066
  • Drug: Placebo
• Experimental: Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg
  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.
  Interventions:

  • Drug: LIK066
  • Drug: Placebo
• Experimental: Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
  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.
  Interventions:

  • Drug: LIK066
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 6, 2014): 14
• Original Estimated Enrollment (submitted: August 1, 2013): 12
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01915849
• Other Study ID Numbers: CLIK066A2201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: January 2015