Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes - Full Text View

Purpose

To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).

Condition	Intervention	Phase
Diabetes	Drug: MBX-2982 Drug: Sitagliptin Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Phase 2, Randomized, Double-Blind, Placebo and Active-Comparator Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Metabolex:

Primary Outcome Measures:

Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the effect of MBX-2982 on additional glycemic parameters. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MBX-2982 25 mg	Drug: MBX-2982 tablets and capsule once daily
Experimental: MBX-2982 100 mg	Drug: MBX-2982 tablets and capsule once daily
Experimental: MBX-2982 300 mg	Drug: MBX-2982 tablets and capsule once daily
Active Comparator: Sitagliptin 100 mg	Drug: Sitagliptin tablets and capsule once daily
Placebo Comparator: Placebo	Drug: placebo tablets and capsule once daily

Detailed Description:

Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of type 2 diabetes of at least 3 months duration
Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
HbA1c 7.0-8.5% (inclusive) at screening
BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India

Exclusion Criteria:

Any history of type 1 diabetes or diabetic ketoacidosis
History of major upper GI surgery
Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
Weight loss > 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035879

Locations

United States, California
Impact Clinical Trials
Los Angeles, California, United States, 90036
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, New York
United Medical Associates
Binghamton, New York, United States, 13901
United States, Texas
dgd Research, Inc., a Cetero Research Co.
San Antonio, Texas, United States, 78229
Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia, 0186
Georgian Diabetes Center
Tbilisi, Georgia, 0159
Healthy Life Clinical Diagnostic Center
Tbilisi, Georgia, 0144
India
Bharti Research Institute of Diabetes and Endocrinology
Karnal, Haryana, India, 132001
Diabetes Thyroid Hormone Research Institute Pvt Ltd
Indore, M.p., India, 452001
Gandhi Endocrinology & Diabetes Centre
Ramdaspeth, Nagpur, India, 10
Medisys Clinisearch India Pvt Ltd
Bangalore, India, 560043
Gokula Metropolis Research, MS Ramaiah Memorial Hospital
Bangalore, India, 560 054
Hormone Care Research Centre
Ghaziabad, India, 201002
Bangalore Endocrinology & Diabetes Research Centre
Malleshwaram, India, 560 003

Sponsors and Collaborators

Metabolex

Investigators

Study Director:

Brian Roberts, MD

Metabolex, Inc.

More Information

No publications provided

Responsible Party:	Brian Roberts, M.D., Director of Clinical Research, Metabolex
ClinicalTrials.gov Identifier:	NCT01035879 History of Changes
Other Study ID Numbers:	M2982-20920
Study First Received:	December 17, 2009
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India Georgia: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013