Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Limerick BioPharma.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Limerick BioPharma
ClinicalTrials.gov Identifier:
NCT01364155
First received: May 25, 2011
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models. Results from a Phase 1b clinical study, conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be potential insulin sensitizers by OGTT.


Condition Intervention Phase
Impaired Glucose Tolerance
Insulin Resistance
Drug: LIM-0705
Drug: Placebo capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Placebo-Controlled Phase 2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR

Resource links provided by NLM:


Further study details as provided by Limerick BioPharma:

Primary Outcome Measures:
  • Evaluate the safety (number of subjects with adverse events) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with impaired glucose tolerance or abnormal HOMA-IR as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Evaluate the tolerability (BID) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 600 mg LIM-0705 BID for 28 days Drug: LIM-0705
Placebo Comparator: Placebo LIM-0705 for 28 days Drug: Placebo capsules

Detailed Description:

The primary objective of the study is to evaluate the safety and tolerability of LIM-0705 administered for 28 days in adult males and females with impaired glucose tolerance or abnormal HOMA-IR.

Secondary Objectives include:

  • examine the pharmacokinetics (PK) of LIM-0705
  • explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with impaired glucose tolerance (defined as two-hour plasma glucose levels of ≥140 to ≤199 mg per dL [7.8 to 11.06 mmol/L] on the 75-g oral glucose tolerance test [OGTT]) or abnormal HOMA-IR (HOMA-IR value ≥ 2.5) as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27
  • explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and females, age 18-75 years old, able and willing to provide written informed consent to participate in the study
  • obesity-induced impaired glucose tolerance or abnormal HOMA-IR
  • waist circumference of 40 inches or greater (men) or 35 inches or greater (women)
  • good physical health based on EKG, electrolytes, LDH, creatinine, urea, AST, ALT, alkaline phosphatase, and renal function
  • male subjects who are sexually active with a female partner of childbearing age must agree to use of 2 effective methods of contraception, including the use of a condom, throughout the course of the study or provide proof of surgical sterility. The second method of contraception must be the use by their female partners of any of the following: a diaphragm with spermicide, a cervical cap with spermicide, an IUD, a female condom, or an approved hormonally based contraceptive (e.g., an oral, transdermal, or implanted estrogen or progestin). Female subjects must be post menopausal or surgically sterile.

Exclusion Criteria:

  • BMI equal to or greater than 40 kg/m2
  • allergy to onions or red wine
  • strict vegetarians
  • use of any non-study medications other than thyroid replacement hormone or anti-hypertensives. Use of cardesarten cilexetil is not permitted. Note: acetaminophen should not be administered.
  • use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within 5 years prior to the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364155

Locations
United States, California
Profil Institute of Clinical Research, Inc. Recruiting
Chula Vista, California, United States, 91911
Contact: Linda Morrow, MD    619-409-1268      
Sponsors and Collaborators
Limerick BioPharma
Investigators
Principal Investigator: Linda Morrow, MD Profil Institute of Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Linda Morrow, MD, Profil Institute for Clinical Research, Inc.
ClinicalTrials.gov Identifier: NCT01364155     History of Changes
Other Study ID Numbers: LIM-0705-CL-2001
Study First Received: May 25, 2011
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 22, 2014