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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01280695•Metabolic Solutions Development Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

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.
+13 more criteria

Locations (14)

Goodyear, Arizona, United States

Chula Vista, California, United States

Los Angeles, California, United States

Bradenton, Florida, United States

Hialeah, Florida, United States

Pembroke Pines, Florida, United States

Chicago, Illinois, United States

Butte, Montana, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

April 14, 2014

Enrollment

129

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Placebo

DRUG

MSDC-0602 100 mg

DRUG

MSDC-0602 250 mg

DRUG

MSDC-0602 250 mg

DRUG

Pioglitazone

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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