Diabetes Mellitus, Type 2Phase 2NCT01280695

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 2 study testing MSDC-0602 100 mg, MSDC-0602 250 mg and Pioglitazone in people with Diabetes Mellitus, Type 2, run by Metabolic Solutions Development Company at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: MSDC-0602 100 mg, MSDC-0602 250 mg and Pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 14 sitesUnited States
Study dates: Feb 2011to Jun 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 31Show fewer

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:
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.
History of alcohol or drug abuse within 6 months of Screening.
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.
Blood donation of 1 pint or more within 56 days of screening.
Plasmapheresis or plasma donation within 30 days of screening.
Single 12-lead ECG demonstrating a QTcB >450 msec at Screening. A single repeat ECG may be done at the Investigator's discretion.
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.
Evidence of clinically relevant pathology that could interfere with the study results or put the patient's safety at risk.
Malignancy, including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Austin, Texas
Study site
Bradenton, Florida
Study site
Butte, Montana
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Goodyear, Arizona
Study site
Greensboro, North Carolina
Study site
Hialeah, Florida
Study site
Los Angeles, California
Study site
Pembroke Pines, Florida
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas

Other trials in United States

About this study

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

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
Being tested: Placebo, MSDC-0602 100 mg, MSDC-0602 250 mg, Pioglitazone
Keywords: Type 2, Diabetes Mellitus, Diabetes, High blood sugar, Blood sugar, Blood glucose, Glucose
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo Capsules
MSDC-0602 100 mgDrug
MSDC-0602 100 mg Capsules
MSDC-0602 250 mgDrug
MSDC-0602 250 mg Capsules
MSDC-0602 250 mgDrug
MSDC-0602 500 mg Capsules
PioglitazoneDrug
Pioglitazone 45 mg Capsules

Study groups in NCT01280695
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo capsule once daily Receives: Drug: Placebo
MSDC-0602 100 mg	Experimental	MSDC-0602 capsule 100 mg once daily Receives: Drug: MSDC-0602 100 mg
MSDC-0602 250 mg	Experimental	MSDC-0602 capsule 250 mg once daily Receives: Drug: MSDC-0602 250 mg
MSDC-0602 500 mg	Experimental	MSDC-0602 capsule 500 mg once daily Receives: Drug: MSDC-0602 250 mg
Pioglitazone 45 mg	Active comparator	Pioglitazone capsule 45 mg once daily Receives: Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 28 days

Secondary outcomes (5)

Change From Baseline in HbA1c
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.
Measured: Baseline and 28 days
Change From Baseline in Body Weight
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.
Measured: Baseline and 28 days
Change From Baseline in Hematocrit
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.
Measured: Baseline and 28 days
Change in Fasting Plasma Insulin
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
Measured: Baseline and 28 days
Change From Baseline in High Molecular Weight Adiponectin
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.
Measured: Baseline and 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Jun 2011

First posted21 Jan 2011 (estimated)
Study startFeb 2011
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01280695
Sponsor's protocol ID: MSDC-0602-C002
Status last verified: Mar 2014
First submitted: 20 Jan 2011
Last updated: 14 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01280695
Acronym / sponsor ID: MSDC-0602-C002
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2, Diabetes Mellitus, Diabetes, High blood sugar, Blood sugar, Blood glucose, Glucose
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Metabolic Solutions Development CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 21 Jan 2011 (estimated)
Results: Posted 20 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsule once daily
MSDC-0602 100 mg	Experimental	Drug: MSDC-0602 100 mgMSDC-0602 capsule 100 mg once daily
MSDC-0602 250 mg	Experimental	Drug: MSDC-0602 250 mgMSDC-0602 capsule 250 mg once daily
MSDC-0602 500 mg	Experimental	Drug: MSDC-0602 250 mgMSDC-0602 capsule 500 mg once daily
Pioglitazone 45 mg	Active comparator	Drug: PioglitazonePioglitazone capsule 45 mg once daily

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

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).

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo Capsules	Drug	Placebo
MSDC-0602 100 mgMSDC-0602 100 mg Capsules	Drug	MSDC-0602 100 mg
MSDC-0602 250 mgMSDC-0602 250 mg Capsules	Drug	MSDC-0602 250 mg
MSDC-0602 250 mgMSDC-0602 500 mg Capsules	Drug	MSDC-0602 500 mg
PioglitazonePioglitazone 45 mg Capsules	Drug	Pioglitazone 45 mg

Primary outcome

Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline and 28 days
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.

5 secondary outcomes

Change From Baseline in HbA1c
Time frame: Baseline and 28 days
Change From Baseline in Body Weight
Time frame: Baseline and 28 days
Change From Baseline in Hematocrit
Time frame: Baseline and 28 days
Change in Fasting Plasma Insulin
Time frame: Baseline and 28 days
Change From Baseline in High Molecular Weight Adiponectin
Time frame: Baseline and 28 days

Results and safety

Results posted to the registry on 20 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	26	26
MSDC-0602 100 mg	25	24
MSDC-0602 250 mg	26	21
MSDC-0602 500 mg	26	22
Pioglitazone 45 mg	26	24

Primary outcome: Change From Baseline in Fasting Plasma Glucose

Time frame: Baseline and 28 days. Median (Inter-Quartile Range). Unit: mg/dL

Measure	Placebo n = 26	MSDC-0602 100 mg n = 22	MSDC-0602 250 mg n = 21	MSDC-0602 500 mg n = 22	Pioglitazone 45 mg n = 23
Value	6.0 (8.90)	-0.5 (9.77)	-20.0 (10.06)	-16.0 (9.68)	-22.0 (9.38)

Placebo vs MSDC-0602 100 mg: Median Difference (Net): -10.0 (95% CI -34.0 to 14.0), p = 0.4195, Wilcoxon (Mann-Whitney)
Placebo vs MSDC-0602 250 mg: Median Difference (Net): -18.0 (95% CI -38.0 to 4.0), p = 0.0811, Wilcoxon (Mann-Whitney)
Placebo vs MSDC-0602 500 mg: Median Difference (Net): -20.0 (95% CI -38.0 to 1.0), p = 0.0639, Wilcoxon (Mann-Whitney)

Population analysed: Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 26 (0%)	2 of 26 (7.7%)	Not reported
MSDC-0602 100 mg	0 of 25 (0%)	0 of 25 (0%)	Not reported
MSDC-0602 250 mg	0 of 26 (0%)	1 of 26 (3.8%)	Not reported
MSDC-0602 500 mg	0 of 26 (0%)	5 of 26 (19.2%)	Not reported
Pioglitazone 45 mg	0 of 26 (0%)	4 of 26 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry Colca, PhD study director

Metabolic Solutions Development Company

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MSDC-0602 100 mg, MSDC-0602 250 mg and Pioglitazone in people with Diabetes Mellitus, Type 2, run by Metabolic Solutions Development Company at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Fasting Plasma Glucose (time frame: Baseline and 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01280695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.