Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin
This study has been terminated.
Sponsor:
Metabolex
Information provided by:
Metabolex
ClinicalTrials.gov Identifier:
NCT00814372
First received: December 22, 2008
Last updated: February 4, 2010
Last verified: January 2010
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: MBX-102 Drug: Placebo Drug: Actos |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Pioglitazone
Pioglitazone hydrochloride
U.S. FDA Resources
Further study details as provided by Metabolex:
Primary Outcome Measures:
- Change in HbA1c from baseline and compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in fasting plasma glucose (FPG) from baseline and vs. placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 240 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MBX-102 400 |
Drug: MBX-102
capsule
|
| Experimental: MBX-102 600 |
Drug: MBX-102
capsule
|
| Placebo Comparator: Placebo |
Drug: Placebo
matching placebo
|
|
Active Comparator: Actos
30-45 mg
|
Drug: Actos
over-encapsulated to match MBX-102 and placebo
|
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%.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814372
Locations
| United States, California | |
| Providence Clinical Research | |
| Burbank, California, United States, 91505 | |
| American Institute of Research | |
| Los Angeles, California, United States, 90017 | |
| United States, Nevada | |
| Nevada Alliance Against Diabetes | |
| Las Vegas, Nevada, United States, 89101 | |
| United States, North Carolina | |
| Piedmont Medical Research Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Texas | |
| DGD Research, Inc. | |
| San Antonio, Texas, United States, 78229 | |
| India | |
| Kamineni Hospitals Pvt, Ltd. | |
| Hyderabad, Andhra Pradesh, India, 50008 | |
| St. John's Medical College & Hospital | |
| Bangalore, India | |
| Bangalore Diabetes Centre | |
| Bangalore, India | |
| Diacon Hospital Diabetes & Research Centre | |
| Bangalore, India | |
| M. S. Ramaiah Memorial Hospital | |
| Bangalore, India | |
| Dr. V. Seshiah Diabetes Care & Research Institute | |
| Chennai, India | |
| Mediciti Hospital | |
| Hyderabad, India | |
| Medwin Hospital | |
| Hyderabad, India | |
| Diabetes Thyroid Hormone Research Institute Pvt. Ltd. | |
| Indore, India | |
| Fortis Hospital | |
| Jaipur, India | |
| Bharti Research Institute of Diabetes & Endocrinology | |
| Karnal, India | |
| Amrita Institute of Medical Sciences | |
| Kochi, India | |
| PD Hindhuja National Hospital | |
| Mumbai, India | |
| Diabetes Action Centre | |
| Mumbai, India, 400067 | |
| BYL Nair Hospital | |
| Mumbai, India | |
| Gandhi Endocrinology & Diabetes Centre | |
| Nagpur, India | |
| All India Institute of Medical Sciences | |
| New Delhi, India | |
| Deenanath Mangeshkar Hospital & Research Centre | |
| Pune, India | |
| Diabetes Care & Research Centre | |
| Pune, India | |
| Health & Research Centre | |
| Trivendrum, India | |
| Christian Medical College | |
| Vellore, India | |
Sponsors and Collaborators
Metabolex
Investigators
| Principal Investigator: | Douglas Denham, M.D. | dgd Research, Inc. |
| Principal Investigator: | Thomas W. Littlejohn, M.D. | Piedmont Medical Research Associates |
| Principal Investigator: | Michael Guice, M.D. | American Institute of Research |
| Principal Investigator: | K. M. Prasanna Kumar, MD | M. S. Ramaiah Memorial Hospital |
| Principal Investigator: | Veerasamy Seshiah, MD | Dr. V. Seshiah Diabetes Care & Research Institute |
| Principal Investigator: | Sanjay Kalra, MD | Bharti Research Institute of Diabetes & Endocrinology |
| Principal Investigator: | Sailesh Lodha, MD | Fortis Hospital |
| Principal Investigator: | Ariachery C Ammini, MD | All India Institute of Medical Sciences, New Delhi |
| Principal Investigator: | Prema Varthakavi, MD | BYL Nair Hospital |
| Principal Investigator: | Sanjiv Shah, MD | Diabetes Action Centre |
| Principal Investigator: | Manoj Chadha, MD | PD Hindhuja National Hospital & Medical Research Centre |
| Principal Investigator: | Mathew Thomas, MD | Health & Research Centre |
| Principal Investigator: | Sanjay Reddy, MD | Bangalore Diabetes Centre |
| Principal Investigator: | Ganapati Bantwal, MD | St. John's Medical College & Hospital |
| Principal Investigator: | Aravind S Sosale, MD | Diacon Hospital Diabetes & Research Centre |
| Principal Investigator: | Vaishali Deshmukh, MD | Deenanath Mangeshkar Hospital & Research Centre |
| Principal Investigator: | Abhay Mutha, MD | Diabetes Care & Research Centre |
| Principal Investigator: | Nihal Thomas, MD | Christian Medical College, Vellore, India |
| Principal Investigator: | Kirtikumar Modi, MD | Medwin Hospital |
| Principal Investigator: | Sunil Jain, MD | Diabetes Thyroid Hormone Research Institute Pvt. Ltd. |
| Principal Investigator: | Pramod Gandhi, MD | Gandhi Endocrinology & Diabetes Centre |
| Principal Investigator: | Rakesh Kumar Sahay, MD | Mediciti Hospital |
| Principal Investigator: | Harish Kumar, MD | Amrita Institute of Medical Sciences |
| Principal Investigator: | Rubin Savedra, MD | Association of International Professionals, dba Nevada Alliance Against Diabetes |
| Principal Investigator: | Teresa Sligh, MD | Translational Research Group, Inc. dba Providence Clinical Research |
| Principal Investigator: | Prabha Adhikari, MD | Kasturba Medical College Hospital |
| Principal Investigator: | Navneet Agrawal, MD | Diabetes, Obesity and Thyroid Center |
| Principal Investigator: | Swamy Miryala, MD | Kamineni Hospitals Pvt, Ltd. |
More Information
No publications provided
| Responsible Party: | Gopal Saha, Director of Clinical Research, Metabolex, Inc. |
| ClinicalTrials.gov Identifier: | NCT00814372 History of Changes |
| Other Study ID Numbers: | M102-20814 |
| Study First Received: | December 22, 2008 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pioglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013