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Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin

Primary Purpose

Type 2 Diabetes Mellitus

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MBX-102

Placebo

Actos

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
Male or female, 18-70 years of age
All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
Female patients must not be pregnant or lactating
BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
HbA1c ≥ 7.5%, ≤ 10.5%
FPG ≥ 120 mg/dL, ≤ 240 mg/dL

Exclusion Criteria:

History of diabetes secondary to pancreatitis or pancreatectomy
Any history of ketoacidosis
History of insulin use within last one year (insulin use while hospitalized is acceptable)
Weight loss > 10 pounds in the three months prior to screening visit
History of TZD use (Actos® or Avandia®) within 6 months of screening visit
History of TZD discontinuation due to side effect or lack of efficacy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

MBX-102 400

MBX-102 600

Placebo

Actos

Arm Description

30-45 mg

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline and compared to placebo

Secondary Outcome Measures

Change in fasting plasma glucose (FPG) from baseline and vs. placebo

Full Information

NCT ID

NCT00814372

First Posted

December 22, 2008

Last Updated

March 30, 2015

Sponsor

CymaBay Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00814372

Brief Title

Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin

Official Title

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of MBX-102/JNJ-39659100 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Why Stopped

MBX-102 did not meet the target efficacy profile of HbA1c change.

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CymaBay Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).

Detailed Description

Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.

6. Conditions and Keywords

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

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBX-102 400

Arm Type

Experimental

Arm Title

MBX-102 600

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Actos

Arm Type

Active Comparator

Arm Description

30-45 mg

Intervention Type

Drug

Intervention Name(s)

MBX-102

Intervention Description

capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

matching placebo

Intervention Type

Drug

Intervention Name(s)

Actos

Intervention Description

over-encapsulated to match MBX-102 and placebo

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

greater than or equal to 1500 mg/kg day

Primary Outcome Measure Information:

Title

Change in HbA1c from baseline and compared to placebo

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change in fasting plasma glucose (FPG) from baseline and vs. placebo

Time Frame

24 weeks

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: Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months Male or female, 18-70 years of age All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded. Female patients must not be pregnant or lactating BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2 HbA1c ≥ 7.5%, ≤ 10.5% FPG ≥ 120 mg/dL, ≤ 240 mg/dL Exclusion Criteria: History of diabetes secondary to pancreatitis or pancreatectomy Any history of ketoacidosis History of insulin use within last one year (insulin use while hospitalized is acceptable) Weight loss > 10 pounds in the three months prior to screening visit History of TZD use (Actos® or Avandia®) within 6 months of screening visit History of TZD discontinuation due to side effect or lack of efficacy

Overall Study Officials: