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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MBX-2044

Placebo for MBX-2044

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®), 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.

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.

Sites / Locations

Diabetes and Glandular Disease Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Arm Label

MBX-2044 1.5 mg

MBX-2044 4.5 mg

MBX-2044 15 mg

MBX-2044 30 mg

MBX-2044 60 mg

MBX-2044 90 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00422487

First Posted

January 15, 2007

Last Updated

April 29, 2015

Sponsor

CymaBay Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00422487

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CymaBay Therapeutics, Inc.

4. Oversight

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBX-2044 1.5 mg

Arm Type

Experimental

Arm Title

MBX-2044 4.5 mg

Arm Type

Experimental

Arm Title

MBX-2044 15 mg

Arm Type

Experimental

Arm Title

MBX-2044 30 mg

Arm Type

Experimental

Arm Title

MBX-2044 60 mg

Arm Type

Experimental

Arm Title

MBX-2044 90 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MBX-2044

Intervention Description

MBX-2044 1.5 mg one capsule daily for 14 days

Intervention Type

Drug

Intervention Name(s)

MBX-2044

Intervention Description

MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days

Intervention Type

Drug

Intervention Name(s)

MBX-2044

Intervention Description

MBX-2044 15 mg one capsule daily for 14 days

Intervention Type

Drug

Intervention Name(s)

MBX-2044

Intervention Description

MBX-2044 30 mg two 15 mg capsules daily for 14 days

Intervention Type

Drug

Intervention Name(s)

MBX-2044

Intervention Description

MBX-2044 60 mg one capsule daily for 14 days

Intervention Type

Drug

Intervention Name(s)

MBX-2044

Intervention Description

MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo for MBX-2044

Intervention Description

Placebo Intervention

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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®), 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherwyn Schwartz, MD

Organizational Affiliation

Diabetes and Glandular Research Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes and Glandular Disease Research Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-4801

Country

United States

12. IPD Sharing Statement

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

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