Diabetes Mellitus, Type 2Phase 3NCT01434186
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
A Phase 3 study testing Metformin IR, Metformin XR and Saxagliptin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 16 sites in 7 countries.
Trial summary
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin IR, Metformin XR and Saxagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 16 sitesin 7 countries
- Study dates
- May 2012to Apr 2016
- Phase
- Phase 3
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
- Previously diagnosed as having type 2 diabetes
- HbA1c ≥7.0% and ≤10.5%
- Body weight ≥ 30 kg
- Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
- Women must have a negative serum or urine pregnancy test
- Women must not be breastfeeding
Who cannot join
- Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
- Fasting plasma glucose (FPG) > 255 mg/dL
- Diabetic ketoacidosis (DKA) within 6 months of study entry
- Abnormal renal function
- Active liver disease
- Anemia
- An abnormal Thyroid Stimulating Hormone (TSH)
- Creatinine kinase (CK) ≥ 3X ULN
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
United States7 sites
Research Site
Cleveland, Ohio
Research Site
Dearborn, Michigan
Research Site
Los Angeles, California
Research Site
Memphis, Tennessee
Research Site
Mineola, New York
Research Site
Saint Paul, Minnesota
Research Site
Tallahassee, Florida
Mexico4 sites
Research Site
Aguascalientes
Research Site
Meridas
Research Site
Monterrey
Research Site
Veracruz
About this study
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
Read the detailed description
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo matching with Saxagliptin, Metformin IR, Metformin XR, Saxagliptin
- 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.
Placebo matching with SaxagliptinDrug
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
Metformin IRDrug
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
Metformin XRDrug
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
SaxagliptinDrug
Also called BMS-477118
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Saxagliptin +Metformin XR/IR | Experimental | Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg Receives: Drug: Metformin IR; Drug: Metformin XR; Drug: Saxagliptin |
| Arm 2: Placebo +Metformin XR/IR | Placebo comparator | Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg Receives: Drug: Placebo matching with Saxagliptin; Drug: Metformin IR; Drug: Metformin XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in HbA1c From Baseline to Week 16
Measured: 16 week short term treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- Study completionApr 2016
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.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434186
- Sponsor's protocol ID
- CV181-147
- Other IDs
- 2010-024568-16
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2011
- Last updated
- 18 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT01434186
- Acronym / sponsor ID
- CV181-147
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
Detailed description
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Saxagliptin +Metformin XR/IR | Experimental | Drug: Metformin IR, Drug: Metformin XR, Drug: SaxagliptinSaxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg |
| Arm 2: Placebo +Metformin XR/IR | Placebo comparator | Drug: Placebo matching with Saxagliptin, Drug: Metformin IR, Drug: Metformin XRPlacebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
- Previously diagnosed as having type 2 diabetes
- HbA1c ≥7.0% and ≤10.5%
- Body weight ≥ 30 kg
- Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
Key exclusion criteria (8 listed)
- Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
- Fasting plasma glucose (FPG) > 255 mg/dL
- Diabetic ketoacidosis (DKA) within 6 months of study entry
- Abnormal renal function
- Active liver disease
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 |
|---|---|---|
| Placebo matching with SaxagliptinTablet, Oral, 0.0 mg, Daily, Day 1 through week 52 | Drug | Arm 2: Placebo +Metformin XR/IR |
| Metformin IRTablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52 | Drug | Arm 1: Saxagliptin +Metformin XR/IR, Arm 2: Placebo +Metformin XR/IR |
| Metformin XRTablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52 | Drug | Arm 1: Saxagliptin +Metformin XR/IR, Arm 2: Placebo +Metformin XR/IR |
| SaxagliptinAlso: BMS-477118Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) | Drug | Arm 1: Saxagliptin +Metformin XR/IR |
Primary outcome
Mean Change in HbA1c From Baseline to Week 16
Time frame: 16 week short term treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin IR, Metformin XR and Saxagliptin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 16 sites in 7 countries.
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 7 inclusion and 8 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Mexico, Belgium, Canada, India and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Apr 2017). 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?
Mean Change in HbA1c From Baseline to Week 16 (time frame: 16 week short term treatment period). 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 18 Apr 2017.