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

NCT01915849 | Completed Phase 1 Results

• 1 other identifier: CLIK066A2201
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose

  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.

  Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)

Study Arms (4)

Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg

EXPERIMENTAL

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.

Drug: LIK066; Drug: Placebo

Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo

EXPERIMENTAL

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.

Drug: LIK066; Drug: Placebo

Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg

EXPERIMENTAL

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.

Drug: LIK066; Drug: Placebo

Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg

EXPERIMENTAL

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.

Drug: LIK066; Drug: Placebo

Interventions

LIK066 DRUG

LIK066 15 mg, 50 mg and 150 mg

Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg; Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo; Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg; Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg

Placebo DRUG

Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg; Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo; Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg; Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Chula Vista, California, 91910, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

licogliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 6, 2015
• Results First Posted: February 6, 2015

Record last verified: 2015-01

Locations

US (1)