Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes

NCT00422487 | Completed Phase 2

• 1 other identifier: M2044-20610
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days

• Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema

• Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration

• Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters

Study Arms (7)

MBX-2044 1.5 mg

EXPERIMENTAL

Drug: MBX-2044

MBX-2044 4.5 mg

EXPERIMENTAL

Drug: MBX-2044

MBX-2044 15 mg

EXPERIMENTAL

Drug: MBX-2044

MBX-2044 30 mg

EXPERIMENTAL

Drug: MBX-2044

MBX-2044 60 mg

EXPERIMENTAL

Drug: MBX-2044

MBX-2044 90 mg

EXPERIMENTAL

Drug: MBX-2044

Placebo

PLACEBO COMPARATOR

Drug: Placebo for MBX-2044

Interventions

MBX-2044 DRUG

MBX-2044 1.5 mg one capsule daily for 14 days

MBX-2044 1.5 mg

Placebo for MBX-2044 DRUG

Placebo Intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or Byetta®
• All female patients must be either surgically sterile or post-menopausal.
• Male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
• BMI 24-44 kg/m2.
• Patients must have a FPG ≤ 200 mg/dL at screening.
• Patients must have Hemoglobin A1c ≥ 6.5%, ≤ 10.0% at screening.
• Electrocardiogram (ECG) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
• Patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.

You may not qualify if:

• History of Type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
• History of TZD use (Actos or Avandia) within 6 months of Screening Visit.
• History of TZD discontinuation due to lack of efficacy.
• History of congestive heart failure within last 5 years.
• History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
• Malignancy within the last 5 years (except resected basal cell carcinoma).
• Ongoing active infection.
• Change in treatment with lipid-lowering agent within 7 days of screening visit.
• Current or expected requirement for anticoagulant therapy \[except for low-dose aspirin ≤ 325 mg/d or Plavix® ≤ 75 mg/d\].
• Current or expected treatment with phenytoin for the duration of the study.
• Known hypersensitivity to NSAIDs.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Diabetes and Glandular Disease Research Associates

San Antonio, Texas, 78229-4801, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Sherwyn Schwartz, MD

  Diabetes and Glandular Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: October 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (1)