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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Metabolic Solutions Development Company
ClinicalTrials.gov Identifier:
NCT01280695
First received: January 20, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: MSDC-0602 100 mg
Drug: MSDC-0602 250 mg
Drug: Pioglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSCD-0602 in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Metabolic Solutions Development Company:

Primary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in HbA1c [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

  • Change From Baseline in Body Weight [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

  • Change From Baseline in Hematocrit [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

  • Change in Fasting Plasma Insulin [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days

  • Change From Baseline in High Molecular Weight Adiponectin [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.


Enrollment: 129
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo capsule once daily
Drug: Placebo
Placebo Capsules
Experimental: MSDC-0602 100 mg
MSDC-0602 capsule 100 mg once daily
Drug: MSDC-0602 100 mg
MSDC-0602 100 mg Capsules
Experimental: MSDC-0602 250 mg
MSDC-0602 capsule 250 mg once daily
Drug: MSDC-0602 250 mg
MSDC-0602 250 mg Capsules
Experimental: MSDC-0602 500 mg
MSDC-0602 capsule 500 mg once daily
Drug: MSDC-0602 250 mg
MSDC-0602 500 mg Capsules
Active Comparator: Pioglitazone 45 mg
Pioglitazone capsule 45 mg once daily
Drug: Pioglitazone
Pioglitazone 45 mg Capsules

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

Inclusion Criteria:

  1. 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).
  2. Between the ages of 18-75 years, inclusive.
  3. 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.

  4. Body Mass Index (BMI) ≥ 25 kg/m2 and ≤ 45 kg/m2 (inclusive).
  5. Willing and able to make a screening visit to the clinic and six visits over a 10 week period.
  6. 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.

Subject Exclusion Criteria:

  1. Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening.
  2. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
  3. Fasting plasma glucose in excess of 240 mg/dl at screening
  4. 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.
  5. 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.
  6. History of nephropathy, neuropathy, or retinopathy within 6 months of screening.
  7. Use of glucocorticoids (oral, injectible, intraarticular, or chronic inhaled) or weight-loss drugs within 3 months of randomization.
  8. Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
  9. Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the patient unlikely to complete the study.
  10. Febrile illness within the 5 days prior to Visit 1.
  11. Known history of HIV, hepatitis B, or hepatitis C.
  12. Clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG.
  13. 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.
  14. 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.
  15. Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.
  16. History of alcohol or drug abuse within 6 months of Screening.
  17. Have participated in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
  18. Blood donation of 1 pint or more within 56 days of screening.
  19. Plasmapheresis or plasma donation within 30 days of screening.
  20. Single 12-lead ECG demonstrating a QTcB >450 msec at Screening. A single repeat ECG may be done at the Investigator's discretion.
  21. Any surgical or medical condition which may significantly alter the absorption of any drug substance including, but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.
  22. Evidence of clinically relevant pathology that could interfere with the study results or put the patient's safety at risk.
  23. Malignancy, including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280695

Locations
United States, Arizona
Goodyear, Arizona, United States
United States, California
Chula Vista, California, United States
Los Angeles, California, United States
United States, Florida
Bradenton, Florida, United States
Hialeah, Florida, United States
Pembroke Pines, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Montana
Butte, Montana, United States
United States, North Carolina
Greensboro, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Austin, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Metabolic Solutions Development Company
Investigators
Study Director: Jerry Colca, PhD Metabolic Solutions Development Company
  More Information

No publications provided

Responsible Party: Metabolic Solutions Development Company
ClinicalTrials.gov Identifier: NCT01280695     History of Changes
Other Study ID Numbers: MSDC-0602-C002
Study First Received: January 20, 2011
Results First Received: October 30, 2013
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Metabolic Solutions Development Company:
Type 2
Diabetes Mellitus
Diabetes
High blood sugar
Blood sugar
Blood glucose
Glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014