A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients

NCT01280695 | Completed Phase 2 Results

• 1 other identifier: MSDC-0602-C002
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2; Diabetes Mellitus; Diabetes; High blood sugar; Blood sugar; Blood glucose; Glucose

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Fasting Plasma Glucose

  To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

  Baseline and 28 days

Secondary Outcomes (5)

• Change From Baseline in HbA1c

  Baseline and 28 days

• Change From Baseline in Body Weight

  Baseline and 28 days

• Change From Baseline in Hematocrit

  Baseline and 28 days

• Change in Fasting Plasma Insulin

  Baseline and 28 days

• Change From Baseline in High Molecular Weight Adiponectin

  Baseline and 28 days

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo capsule once daily

Drug: Placebo

MSDC-0602 100 mg

EXPERIMENTAL

MSDC-0602 capsule 100 mg once daily

Drug: MSDC-0602 100 mg

MSDC-0602 250 mg

EXPERIMENTAL

MSDC-0602 capsule 250 mg once daily

Drug: MSDC-0602 250 mg

MSDC-0602 500 mg

EXPERIMENTAL

MSDC-0602 capsule 500 mg once daily

Drug: MSDC-0602 250 mg

Pioglitazone 45 mg

ACTIVE COMPARATOR

Pioglitazone capsule 45 mg once daily

Drug: Pioglitazone

Interventions

Placebo DRUG

Placebo Capsules

Placebo

MSDC-0602 100 mg DRUG

MSDC-0602 100 mg Capsules

MSDC-0602 100 mg

MSDC-0602 250 mg DRUG

MSDC-0602 250 mg Capsules

MSDC-0602 250 mg

Pioglitazone DRUG

Pioglitazone 45 mg Capsules

Pioglitazone 45 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females with Type 2 diabetes (fasting plasma glucose ≥126 mg/dL at screening, glycosylated hemoglobin \[HbA1c\] \>7 and ≤10%, and Insulin C-peptide \>1 ng/mL). Patients can be naïve to diabetes therapy or if taking metformin should be on a stable dose level for a period of at least 3 months prior to screening visit (no dose limit).
• Between the ages of 18-75 years, inclusive.
• Females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). Menopausal status will be verified by a follicle-stimulating hormone (FSH) test. If FSH levels are below 40 mIU/mL, some method of birth control must be used. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screen and Day 15 regardless of childbearing potential. For postmenopausal women only, if FSH levels are above 40 mIU/mL and serum pregnancy results are indeterminant, the subject will be assessed as not pregnant.
• Males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse.
• Body Mass Index (BMI) ≥ 25 kg/m2 and ≤ 45 kg/m2 (inclusive).
• Willing and able to make a screening visit to the clinic and six visits over a 10 week period.
• Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

You may not qualify if:

• Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening.
• History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
• Fasting plasma glucose in excess of 240 mg/dl at screening
• History of heart failure (including CHF) or previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to screening.
• ALT and/or AST levels that equal or exceed twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine \>1.5 mg/dL in men or \> 1.4 mg/dL in women.
• History of nephropathy, neuropathy, or retinopathy within 6 months of screening.
• Use of glucocorticoids (oral, injectible, intraarticular, or chronic inhaled) or weight-loss drugs within 3 months of randomization.
• Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
• Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the patient unlikely to complete the study.
• Febrile illness within the 5 days prior to Visit 1.
• Known history of HIV, hepatitis B, or hepatitis C.
• Clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG.
• Blood pressure greater than 160/100 mmHg. Patients with elevated BP (\<160/100 mmHg) with or without current treatment will be allowed at the discretion of the Principal Investigator (PI) and primary care physician. Individuals with hypertension must have been stabilized to the current treatment regimen for at least 6 weeks prior to screening.
• Change in BP or lipid-lowering medication within 6 weeks or change in dose of metformin or thyroid replacement within 3 months prior to screening.
• Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.

Sponsors & Collaborators

• Metabolic Solutions Development Company: lead

Study Sites (14)

Unknown Facility

Goodyear, Arizona, United States

Location

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Butte, Montana, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia

Interventions

MSDC-0602; Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jerry Colca, PhD
• Organization: Metabolic Solutions Development Company

jcolca@msdrx.com

269.343.6732

Study Officials

• Jerry Colca, PhD

  Metabolic Solutions Development Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 14, 2014
• Results First Posted: December 20, 2013

Record last verified: 2014-03

Locations

US (14)