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

• Sponsor: CymaBay Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01035879
• Collaborator: (none)
• Enrollment: 100
• Locations: 14
• Arms: 5
• Duration (Months): 8
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diabetes	Drug: MBX-2982; Drug: MBX-2982; Drug: MBX-2982; Drug: Sitagliptin; Drug: placebo	Phase 2

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%.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 [4 weeks]

Secondary Outcome Measures

1. Evaluate the effect of MBX-2982 on additional glycemic parameters. [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

• CymaBay Therapeutics, Inc.

Investigators

• Study Director: Brian Roberts, MD, Metabolex, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CymaBay Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01035879
• Other Study ID Numbers: M2982-20920
• First Posted: Dec 21, 2009
• Last Update Posted: Apr 17, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus; Sitagliptin Phosphate

Study Results

No Results Posted as of Apr 17, 2015