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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of MBX-2044 to Evaluate the Multiple-dose Pharmacokinetics, Safety and Tolerability When Administered Orally in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422487
• Other study ID #: M2044-20610
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2007
• Last updated: April 29, 2015
• Start date: October 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2015
• Source: CymaBay Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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®), a-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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MBX-2044
MBX-2044 1.5 mg one capsule daily for 14 days
• MBX-2044
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
• MBX-2044
MBX-2044 15 mg one capsule daily for 14 days
• MBX-2044
MBX-2044 30 mg two 15 mg capsules daily for 14 days
• MBX-2044
MBX-2044 60 mg one capsule daily for 14 days
• MBX-2044
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
• Placebo for MBX-2044
Placebo Intervention

Locations

Country	Name	City	State
United States	Diabetes and Glandular Disease Research Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CymaBay Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
Primary	Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
Primary	Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
Primary	Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters