Type 2 Diabetes MellitusPhase 2NCT01240759
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
A Phase 2 study testing S-707106 Dose A, S-707106 Dose B and S-707106 Dose C in people with Type 2 Diabetes Mellitus, run by Shionogi at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- S-707106 Dose A, S-707106 Dose B and S-707106 Dose C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- 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
Main Inclusion Criteria:
- Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history
- Body mass index (BMI) ≥25.0 and <45.0 (kg/m2) using http://www.bmicalculator.org/ as the BMI calculator
- No clinically significant abnormal laboratory tests as determined by the investigator except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level >1.0 ng/mL
Main Exclusion Criteria:
- Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months
- Use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year
- Congestive heart failure as defined by New York Heart Association class III or IV
- Fasting glucose >270 mg/dL
- Creatinine clearance is <60 mL/minute
- History of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.
Read the detailed description
Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- S-707106 Dose A, S-707106 Dose B, S-707106 Dose C, Placebo A tablet, Metformin
- Keywords
- Type 2 Diabetes Mellitus, Metformin
- 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.
S-707106 Dose ADrug
One S-707106 A tablet
S-707106 Dose BDrug
One S-707106 B tablet
S-707106 Dose CDrug
Four S-707106 4 X B tablets
Placebo A tabletDrug
Up to 4 Placebo A tablets
MetforminDrug
The standard of care dose of metformin for each patient
| Study group | Role | What they receive |
|---|---|---|
| S-707106 Dose A | Experimental | One S-707106 A tablet + 3 Placebo A tablets Receives: Drug: S-707106 Dose A; Drug: Placebo A tablet; Drug: Metformin |
| S-707106 Dose B | Experimental | One S-707106 B tablet + 3 Placebo A tablets Receives: Drug: S-707106 Dose B; Drug: Placebo A tablet; Drug: Metformin |
| S-707106 Dose C | Experimental | S-707106 Dose C = Four S-707106 B tablets Receives: Drug: S-707106 Dose C; Drug: Metformin |
| Metformin | Active comparator | The standard of care dose of metformin for the individual patient + 3 Placebo A tablets Receives: Drug: Placebo A tablet; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Hemoglobin A1c
Measured: Baseline and at 12 weeks
Secondary outcomes (5)
Serial pharmacokinetic (PK) assessments
Serial pharmacokinetic sampling at Visit 6 prior to dosing, at Visit 7 prior to dosing and at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours after dosing, at Visit 8, at Visit 9, and Early Termination Visit
Measured: 5 days
Sparse pharmacokinetic assessments
Sparse pharmacokinetic sampling at Visit 6 and Visit 7 prior to dosing, at Visit 6 or Visit 7 one additional post-dose sample, at Visit 8, at Visit 9, and Early Termination Visit
Measured: 5 days
Percent of subjects with Hemoglobin A1c < 7.0% at Week 12
Hemoglobin A1c
Measured: 12 weeks
Change from Baseline at Week 12 in: Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test
Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test
Measured: Baseline and at 12 weeks
Safety assessments
Safety will be assessed by monitoring of treatment-emergent adverse events, serious adverse events, treatment-emergent adverse events leading to study drug discontinuation, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms (ECGs), adrenal axis hormones, and treatment-emergent adverse events of hypoglycemia, hyperglycemia, confirmed hypoglycemia or hyperglycemia
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240759
- Sponsor's protocol ID
- 1010N0921
- Status last verified
- May 2018
- First submitted
- 11 Nov 2010
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
- ClinicalTrials.gov ID
- NCT01240759
- Acronym / sponsor ID
- 1010N0921
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Nov 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 S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.
Detailed description
Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S-707106 Dose A | Experimental | Drug: S-707106 Dose A, Drug: Placebo A tablet, Drug: MetforminOne S-707106 A tablet + 3 Placebo A tablets |
| S-707106 Dose B | Experimental | Drug: S-707106 Dose B, Drug: Placebo A tablet, Drug: MetforminOne S-707106 B tablet + 3 Placebo A tablets |
| S-707106 Dose C | Experimental | Drug: S-707106 Dose C, Drug: MetforminS-707106 Dose C = Four S-707106 B tablets |
| Metformin | Active comparator | Drug: Placebo A tablet, Drug: MetforminThe standard of care dose of metformin for the individual patient + 3 Placebo A tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| S-707106 Dose AOne S-707106 A tablet | Drug | S-707106 Dose A |
| S-707106 Dose BOne S-707106 B tablet | Drug | S-707106 Dose B |
| S-707106 Dose CFour S-707106 4 X B tablets | Drug | S-707106 Dose C |
| Placebo A tabletUp to 4 Placebo A tablets | Drug | Metformin, S-707106 Dose A, S-707106 Dose B |
| MetforminThe standard of care dose of metformin for each patient | Drug | Metformin, S-707106 Dose A, S-707106 Dose B, S-707106 Dose C |
Primary outcome
Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Time frame: Baseline and at 12 weeks
Hemoglobin A1c
5 secondary outcomes
Serial pharmacokinetic (PK) assessments
Time frame: 5 days
Sparse pharmacokinetic assessments
Time frame: 5 days
Percent of subjects with Hemoglobin A1c < 7.0% at Week 12
Time frame: 12 weeks
Change from Baseline at Week 12 in: Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test
Time frame: Baseline and at 12 weeks
Safety assessments
Time frame: 5-6 months
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 15 May 2018.
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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.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-707106 Dose A, S-707106 Dose B and S-707106 Dose C in people with Type 2 Diabetes Mellitus, run by Shionogi at 1 site 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?
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 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 from Baseline to Week 12 in Hemoglobin A1c (HbA1c) (time frame: Baseline and at 12 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 15 May 2018.