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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014