Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Phase 2/3, Randomized, Double-blind, Placebo- and Active Comparator-controlled, Parallel, Multicenter Study to Determine Safety and Efficacy of Metaglidasen in Treatment of Type 2 Diabetes Suboptimally Controlled on Insulin
1 other identifier
interventional
396
4 countries
67
Brief Summary
This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly controlled on their existing therapy. Preference for enrollment will be given to patients on insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with intermediate-acting insulin may qualify for the study if both the patient and investigator are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the short acting insulin for at least 26 weeks. Patients treated with a sliding scale of short-acting insulin will not be eligible for enrollment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started May 2006
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 14, 2006
CompletedFirst Posted
Study publicly available on registry
July 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMay 1, 2015
April 1, 2015
1.5 years
July 14, 2006
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c
Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema
Study Arms (5)
MBX-102 200 mg
EXPERIMENTALMBX-102 200 mg once daily for 16 weeks
MBX-102 400 mg
EXPERIMENTALMBX-102 400 mg once daily for 16 weeks
MBX-102 600 mg
EXPERIMENTALMBX-102 600 mg once daily for 16 weeks
Sugar Pill
PLACEBO COMPARATORPlacebo comparator once daily for 16 weeks
Actos
ACTIVE COMPARATORActos 30 mg once daily for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes (as described by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus24) treated with insulin alone (a stable dose of long and/or intermediate-acting insulin or pre-mixed insulin e.g., "70/30") ≥ 30 units/day for at least 3 months, but poorly controlled on their existing therapy
- Or, patients treated with insulin (as above) in combination with non-TZD hypoglycemic agents (e.g., a sulfonylurea, metformin, acrabose, or Byetta for at least 3 months, but poorly controlled on their existing therapy
- Or, patients treated with fixed doses of short-acting insulin in combination with intermediate-acting insulin for at least 3 months, but poorly controlled on their existing therapy
- Patients in last 2 categories must be willing to discontinue the use of OHA and/or short-acting insulin (or change to pre-mixed insulin) for at least 26 weeks.
- Male or female, 18-75 years of age
- Provide informed consent and agree to comply with study requirements
- Current monotherapy insulin dose regimen ≥ 30 units/day (stable for 8-week Run-in/stabilization Period); or patients who need insulin dose adjustment must have a stabilized dose ≥ 30 units/day. Patients must not have taken TZDs within 5 months of screening
- All female patients must be surgically sterile, post-menopausal (at least 40 years of age with no history of menses for at least 2 years) or agree to use adequate contraception(s) that must include a barrier method (other methods may include oral contraceptives, double barrier methods, intra-uterine devices, or abstinence). Depo contraceptives are excluded
- Female patients must not be pregnant or lactating
- BMI 26-44 kg/m2
- Hemoglobin A1c must be ≥7.5%, ≤11.5% at both Screening and Visit 4
- Patients must have a FPG ≤ 220 mg/dl
- Patients must have liver function tests ≤ 2X the upper limits of normal for AST, ALT, and bilirubin, and ≤ 2.5X the upper limits of normal for ALP and GGT
- Patients must have serum creatinine ≤ 1.8 mg/dl for males and ≤ 1.5 mg/dl for females and BUN ≤ 40 mg/dl
- Fecal occult blood test must be negative
- +4 more criteria
You may not qualify if:
- Patients will be excluded from study participation if any of the following applies:
- History of diabetes secondary to pancreatitis or pancreatectomy
- Requirement for short-acting insulin during the study
- Weight loss \> 10 pounds in the three months prior to study
- History of TZD use (Actos or Avandia) within 5 months of Screening Visit
- History of TZD discontinuation due to side effect or lack of efficacy
- Prior history of endoscopically or radiographically documented peptic ulcer disease within last 5 years (unless patient had documented H. pylori infection with subsequent treatment and no recurrence)
- Prior history of GI bleeding within last 5 years (except for hemorrhoids or perianal disease)
- Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
- History of congestive heart failure within last 5 years (NYHA Class III-IV)
- History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year
- Elevated creatine phosphokinase (\> 2X the upper limits of normal)
- Malignancy within the last 5 years (except resected basal cell carcinoma)
- Ongoing active infection, as evidenced by symptoms such as temperature \> 38.5° C and/or clinically significant elevation in WBC count (i.e., not asymptomatic colonization)
- Change in treatment with lipid-lowering agent after screening visit
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (67)
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620, United States
The Intermed Group
Los Angeles, California, 90017, United States
LAC/USC Medical Center
Los Angeles, California, 90033, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684, United States
Andres Patron DO PA
Pembroke Pines, Florida, 33026, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Olive Branch Research
Olive Branch, Mississippi, 38654, United States
Optimed Research, LLC
Columbus, Ohio, 43235, United States
Radiant Research - Greer
Greer, South Carolina, 29651, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
Mercury Pharma Services
Houston, Texas, 77081, United States
Diabetes Center of the Southwest
Midland, Texas, 79705, United States
Diabetes & Glandular Disease Research Associates, P.A.
San Antonio, Texas, 78229, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
National Clinical Research
Richmond, Virginia, 23294, United States
Consultorio Integral de Atencion al Diabetico (CIAD)
Buenos Aires, B1708IFF, Argentina
CIMEL
Buenos Aires, B1824KAJ, Argentina
Centro de Atencion Integral en Diabetes, Endocrinologica y Metabolismo
Buenos Aires, B6740CWC, Argentina
Fundacion CIDEA
Buenos Aires, C1121ABE, Argentina
Sanatorio Municipal Dr. Julio Mendez
Buenos Aires, C1405CNF, Argentina
Instituto Medico Especializado
Buenos Aires, C1405CWB, Argentina
Hospital Thompson
Buenos Aires, CP1650, Argentina
Clinica Dleta Zarate
Buenos Aires, Argentina
Hospital Privado de Comunidad
Buenos Aires, Argentina
Consultorios Asociados de Endocrinologia
Capital Federal, Argentina
Instituto Latinoamericano de Investigaciones Clinicas
Córdoba, X5000BNB, Argentina
Sanatorio Parque
Córdoba, X5000IKK, Argentina
Fundacion Marcelino Rusculleda Batlle
Córdoba, Argentina
Instituto de Clinica Medica y Diabetes
Mendoza, M5519XAC, Argentina
Policlio Modelo de Cipoletti
Rio Negro, R8324BSS, Argentina
Hospital San Bernardo
Salta, A4406CLA, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan Capital, Argentina
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, Andhra Pradesh, 500082, India
Bharti Research Institute of Diabetes & Endocrinology
Karnāl, Haryana, India
Amrita Institute of Medical Sciences
Kochi, Kerala, 682026, India
Kasturba Medical College Hospital
Attavar, Mangalore, 575001, India
Sterling Hospital
Ahmedabad, India
St. John's Medical College Hospital
Bangalore, 560034, India
M.S. Ramaih Medical College & Hospital
Bangalore, 560054, India
Diacon Hospital
Bangalore, India
Sri Ramachandra Medical Centre
Chennai, 600 116, India
Dr. V. Seshiah Diabetes Care & Research Institute
Chennai, India
Apollo Gleneages/Dept. of Endocrinology
Kolkata, India
Diabetes Care and Research Center
Maharashtra, 411011, India
Kasturba Hospital
Manipal, 576104, India
Chowpatty Medical Center
Mumbai, India
Mediheights Healthcare Pvt. Ltd.
Mumbai, India
KEM Hospital
Pune, 411 011, India
Kerala Institute of Medical Sciences
Trivandrum, India
Christian Medical College Hospital
Vellore, 632004, India
Endocrinology Institute, Haemek Medical Center
Afula, Israel
Barzilai Medical Center
Ashkelon, Israel
Soroka Medical Center
Beersheba, 84101, Israel
Rambam Medical Center
Haifa, 31996, Israel
Linn Medical Center
Haifa, 34780, Israel
Wolfson Medical Center
Holon, 58100, Israel
Hadassah University Hospital
Jerusalem, 91120, Israel
Clalit Health Services
Jerusalem, 93106, Israel
Institution of Diabetes and Metabolism
Nahariya, 22100, Israel
Endocrinology & Diabetes Institute
Petah Tikva, Israel
Department of Endocrinology, Ziv Medical Center
Safed, 13091, Israel
Zamenhoff Medical Center
Tel Aviv, 64353, Israel
Institute of Metabolic Diseases
Tel Aviv, Israel
Assaf Haroffe Medical Center
Zrifin, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2006
First Posted
July 18, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
May 1, 2015
Record last verified: 2015-04