Type 2 DiabetesPhase 3NCT00918138
Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
A Phase 3 study testing Saxagliptin and Metformin XR in people with Type 2 Diabetes, run by AstraZeneca at 21 sites in 4 countries.
Trial summary
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Saxagliptin and Metformin XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Aug 2009to May 2010
- 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 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- 18-78 years of age
- Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
- Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- Fasting C-peptide: ≥1.0 ng/mL
- FPG≥126 mg/dl obtained at the Day -7 visit
- Body mass index (BMI): ≤ 40kg/m²
- A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization
Who cannot join
- Women of childbearing potential unable or unwilling to use acceptable birth control
- Women who are pregnant or breastfeeding
- Significant cardiovascular history
- Active liver disease
- Renal impairment
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States12 sites
River Birch Research Alliance, Llc
Blue Ridge, Georgia, 30513
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45212
Clinical Research Of South Florida
Coral Gables, Florida, 33134
Palm Springs Research Institute
Hialeah, Florida, 33012
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007
Clinilabs, Inc.
New York, New York, 10019
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161
Dedicated Phase I, Inc.
Phoenix, Arizona, 85013
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, 92373
Clinical Trials Of Texas Inc.
San Antonio, Texas, 78229
Orange County Research Center
Tustin, California, 92780
Advanced Clinical Research
West Jordan, Utah, 84088
Israel4 sites
Local Institution
Beersheba, 84101
Local Institution
Holon, 58100
Local Institution
Kfar Saba, 44281
Local Institution
Safed, 13100
Mexico3 sites
Local Institution
Durango, Durango, 34000
Local Institution
Durango, Durango, 34075
Local Institution
Monterrey, Nuevo León, 64460
Argentina2 sites
Local Institution
Buenos Aires, Buenos Aires, 1425
Local Institution
Capital Federal, Buenos Aires, 1429
About this study
Official title: A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
- Conditions
- Type 2 Diabetes
- Being tested
- Saxagliptin, Metformin XR, Placebo matching Metformin XR, Placebo matching 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.
SaxagliptinDrug
Also called BMS-477118, Onglyza
Tablets, Oral, 5 mg, once daily, 4 weeks
Metformin XRDrug
Also called Glucophage XR®
Tablets, Oral, 1500 mg, once daily, 4 weeks
Placebo matching Metformin XRDrug
Tablets, Oral, 0 mg, once daily, 4 weeks
Metformin XRDrug
Also called Glucophage XR®
Tablets, Oral, 500 mg, once daily, 4 weeks
Placebo matching SaxagliptinDrug
Tablets, Oral, 0 mg, once daily, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Saxagliptin + Metformin XR + matching Metformin XR placebo | Experimental | (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) Receives: Drug: Saxagliptin; Drug: Metformin XR; Drug: Placebo matching Metformin XR |
| Metformin XR + Metformin XR + matching Saxagliptin placebo | Active comparator | (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo) Receives: Drug: Metformin XR; Drug: Placebo matching Saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4
Secondary outcomes (2)
Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)
Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Measured: Baseline, Week 4
Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal
FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
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 Type 2 DiabetesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918138
- Sponsor's protocol ID
- CV181-085
- Status last verified
- May 2015
- First submitted
- 9 Jun 2009
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
- ClinicalTrials.gov ID
- NCT00918138
- Acronym / sponsor ID
- CV181-085
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 6 Oct 2011
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 was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saxagliptin + Metformin XR + matching Metformin XR placebo | Experimental | Drug: Saxagliptin, Drug: Metformin XR, Drug: Placebo matching Metformin XR(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) |
| Metformin XR + Metformin XR + matching Saxagliptin placebo | Active comparator | Drug: Metformin XR, Drug: Placebo matching Saxagliptin(Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo) |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes
- 18-78 years of age
- Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
- Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- Fasting C-peptide: ≥1.0 ng/mL
Key exclusion criteria (5 listed)
- Women of childbearing potential unable or unwilling to use acceptable birth control
- Women who are pregnant or breastfeeding
- Significant cardiovascular history
- Active liver disease
- Renal impairment
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 |
|---|---|---|
| SaxagliptinAlso: BMS-477118, OnglyzaTablets, Oral, 5 mg, once daily, 4 weeks | Drug | Saxagliptin + Metformin XR + matching Metformin XR placebo |
| Metformin XRAlso: Glucophage XR®Tablets, Oral, 1500 mg, once daily, 4 weeks | Drug | Metformin XR + Metformin XR + matching Saxagliptin placebo, Saxagliptin + Metformin XR + matching Metformin XR placebo |
| Placebo matching Metformin XRTablets, Oral, 0 mg, once daily, 4 weeks | Drug | Saxagliptin + Metformin XR + matching Metformin XR placebo |
| Metformin XRAlso: Glucophage XR®Tablets, Oral, 500 mg, once daily, 4 weeks | Drug | Metformin XR + Metformin XR + matching Saxagliptin placebo |
| Placebo matching SaxagliptinTablets, Oral, 0 mg, once daily, 4 weeks | Drug | Metformin XR + Metformin XR + matching Saxagliptin placebo |
Primary outcome
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Time frame: Baseline, Week 4
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
2 secondary outcomes
Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)
Time frame: Baseline, Week 4
Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- 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
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saxagliptin and Metformin XR in people with Type 2 Diabetes, run by AstraZeneca at 21 sites in 4 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 8 inclusion and 5 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Israel, Mexico, Argentina. 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 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 6 Oct 2011). 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 24-Hour Mean Weighted Glucose (MWG) at Week 4 (time frame: Baseline, Week 4). 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 21 May 2015.