Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01407003
First received: July 20, 2011
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus (T2DM) |
Drug: LIK066 or a matching placebo Drug: LIK066 Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, 4-part, Interwoven Single- and Multiple-ascending Dose Study to Assess Safety, Tolerability, PK and PD of LIK066 in Healthy Subjects and in Patients With T2DM |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability of single and multiple dose(s) of LIK066: number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis). [ Time Frame: Daily during treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in fasting and post-challenge plasma glucose after 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: Yes ]
- Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration [ Time Frame: Day 1 and End of Treatment ] [ Designated as safety issue: No ]
- Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 168 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LIK066 in healthy subjects |
Drug: LIK066 or a matching placebo
Drug: LIK066
Participants will receive a single or multiple doses of LIK066
|
| Placebo Comparator: Matching placebo in healthy subjects |
Drug: Placebo
Participants will receive a single or multiple doses of a matching placebo
|
| Experimental: LIK066 in patients with type 2 diabetes mellitus |
Drug: LIK066
Participants will receive a single or multiple doses of LIK066
|
| Placebo Comparator: Matching placebo in patients with type 2 diabetes mellitus |
Drug: Placebo
Participants will receive a single or multiple doses of a matching placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Parts I and III: Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
- Parts II and IV: Patients, age 18-65 years, must have been diagnosed with T2DM at least 8 weeks prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
- Fasting plasma glucose ≤250mg/dL at screening and baseline.
- 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; all parts:
- Patients with type 1 diabetes mellitus.
- Patients with history of acute diabetic complications within the 6 months prior to screening.
- Women of child-bearing potential.
- 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: NCT01407003
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 |
Locations
| United States, Florida | |
| Novartis Investigative Site | Recruiting |
| Miami, Florida, United States, 33126 | |
| United States, Nebraska | |
| Novartis Investigative Site | Recruiting |
| Lincoln, Nebraska, United States, 68502 | |
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: | NCT01407003 History of Changes |
| Other Study ID Numbers: | CLIK066X2101 |
| Study First Received: | July 20, 2011 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
T2DM, blood glucose, OGTT, LIK066 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013