Type 2 DiabetesPhase 2NCT01169090
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
A Phase 2 study testing SK-0403 and Sitagliptin in people with Type 2 Diabetes, run by Kowa Research Institute, Inc. at 40 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SK-0403 and Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 40 sitesUnited States
- Study dates
- Jul 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
- Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies [DPP-4 inhibitors and GLP-1 analogues]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
- No antidiabetic medication other than metformin for 3 months prior to randomization.
- Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
- Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.
Who cannot join
- History of type 1 diabetes.
- Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
- Use of 3 or more oral antidiabetic medications at the time of the screening visit.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Study site
Beaver, Pennsylvania
Study site
Birmingham, Alabama
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Encinitas, California
Study site
Eugene, Oregon
Study site
Greensboro, South Carolina
Study site
Greenville, North Carolina
Study site
Honolulu, Hawaii
Study site
Houston, Texas
Study site
Huntington Park, California
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Marion, Ohio
Study site
Miami, Florida
Study site
Mount Giliad, Ohio
Study site
Muscle Shoals, Alabama
Study site
New Orleans, Louisiana
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Paducah, Kentucky
Study site
Palm Harbour, Florida
Study site
Pembroke Pines, Florida
Study site
Phoenix, Arizona
Study site
Portland, Oregon
Study site
Richmond, Virginia
Study site
Saint Paul, Minnesota
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Mateo, California
Study site
Sandy City, Utah
Study site
Spring Valley, California
Study site
Statesville, North Carolina
Study site
Walnut Creek, California
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
- Conditions
- Type 2 Diabetes
- Being tested
- SK-0403, Placebo, Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-0403Drug
SK-0403
PlaceboDrug
Placebo
SitagliptinDrug
Sitagliptin
| Study group | Role | What they receive |
|---|---|---|
| SK-0403 100 mg QD | Experimental | Not described Receives: Drug: SK-0403 |
| SK-0403 200 mg QD | Experimental | Not described Receives: Drug: SK-0403 |
| SK-0403 400 mg QD | Experimental | Not described Receives: Drug: SK-0403 |
| SK-0403 200 mg BID | Experimental | Not described Receives: Drug: SK-0403 |
| Placebo | Sham comparator | Not described Receives: Drug: Placebo |
| Sitagliptin 100 mg QD | Active comparator | Not described Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to Week 16.
Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).
Measured: Baseline, 16 weeks
Secondary outcomes (1)
Change from baseline in Fasting Plasma Glucose (FPG)
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169090
- Sponsor's protocol ID
- SK-0403-2.01US
- Status last verified
- Aug 2011
- First submitted
- 22 Jul 2010
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
- ClinicalTrials.gov ID
- NCT01169090
- Acronym / sponsor ID
- SK-0403-2.01US
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
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 evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SK-0403 100 mg QD | Experimental | Drug: SK-0403 |
| SK-0403 200 mg QD | Experimental | Drug: SK-0403 |
| SK-0403 400 mg QD | Experimental | Drug: SK-0403 |
| SK-0403 200 mg BID | Experimental | Drug: SK-0403 |
| Placebo | Sham comparator | Drug: Placebo |
| Sitagliptin 100 mg QD | Active comparator | Drug: Sitagliptin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
- Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies [DPP-4 inhibitors and GLP-1 analogues]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
- No antidiabetic medication other than metformin for 3 months prior to randomization.
- Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
- Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.
Key exclusion criteria (3 listed)
- History of type 1 diabetes.
- Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
- Use of 3 or more oral antidiabetic medications at the time of the screening visit.
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 |
|---|---|---|
| SK-0403SK-0403 | Drug | SK-0403 100 mg QD, SK-0403 200 mg BID, SK-0403 200 mg QD, SK-0403 400 mg QD |
| PlaceboPlacebo | Drug | Placebo |
| SitagliptinSitagliptin | Drug | Sitagliptin 100 mg QD |
Primary outcome
Change in HbA1c from baseline to Week 16.
Time frame: Baseline, 16 weeks
Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).
1 secondary outcome
Change from baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline, 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
40 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 SK-0403 and Sitagliptin in people with Type 2 Diabetes, run by Kowa Research Institute, Inc. at 40 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 5 inclusion and 3 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 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in HbA1c from baseline to Week 16. (time frame: Baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2011.