Type 2 DiabetesPhase 3NCT00374907

A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Phase 3 study testing Saxagliptin, Metformin (blinded) and Metformin (open-label) in people with Type 2 Diabetes, run by AstraZeneca at 3 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 clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Saxagliptin, Metformin (blinded) and Metformin (open-label)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 3 sitesUnited States
Study dates: Sep 2006to Dec 2009
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus
Drug naive
Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
Fasting C-peptide ≥1.0 ng/mL
Body mass index ≤40 kg/m²

Who cannot join

Recent cardiac or cerebrovascular event
Elevated serum creatinine

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Diabetes & Glandular Disease Research Assoc,, Inc.
San Antonio, Texas, 78229
Va San Diego Healthcare System
San Diego, California, 92161

Other trials in United States

About this study

Official title: Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

Read the detailed description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Placebo, Metformin (blinded), Metformin (open-label)
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
Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
PlaceboDrug
Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
Metformin (blinded)Drug
Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
Metformin (open-label)Drug
Tablets, Oral, 500-1500 mg, as needed (starting in LT)

Study groups in NCT00374907
Study group	Role	What they receive
Saxagliptin (A)	Experimental	Metformin 500-1500 mg (open-label, as needed for rescue in LT) Receives: Drug: Saxagliptin
Placebo (ST) / Metformin (LT) (B)	Placebo comparator	Metformin 500-1500 mg (open-label, as needed for rescue in LT) Receives: Drug: Placebo; Drug: Metformin (blinded); Drug: Metformin (open-label)

What is being measured

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

Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Measured: Baseline, Week 12

Secondary outcomes (1)

Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Measured: Baseline, Week 12

Timeline

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

Sep 2006Dec 2009

First posted12 Sep 2006 (estimated)
Study startSep 2006
Primary completionJan 2008
Study completionDec 2009

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00374907
Sponsor's protocol ID: CV181-041
Status last verified: Mar 2015
First submitted: 7 Sep 2006
Last updated: 7 May 2015
Results posted: Yes, on ClinicalTrials.gov

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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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT00374907
Acronym / sponsor ID: CV181-041
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jan 2008 (actual)
Study completion: Dec 2009 (actual)
First posted: 12 Sep 2006 (estimated)
Results: Posted 21 Jan 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 clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Saxagliptin (A)	Experimental	Drug: SaxagliptinMetformin 500-1500 mg (open-label, as needed for rescue in LT)
Placebo (ST) / Metformin (LT) (B)	Placebo comparator	Drug: Placebo, Drug: Metformin (blinded), Drug: Metformin (open-label)Metformin 500-1500 mg (open-label, as needed for rescue in LT)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 diabetes mellitus
Drug naive
Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
Fasting C-peptide ≥1.0 ng/mL
Body mass index ≤40 kg/m²

Key exclusion criteria (2 listed)

Recent cardiac or cerebrovascular event
Elevated serum creatinine

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-477118Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)	Drug	Saxagliptin (A)
PlaceboTablet, Oral, 0 mg, Once daily (up to 12 weeks ST)	Drug	Placebo (ST) / Metformin (LT) (B)
Metformin (blinded)Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)	Drug	Placebo (ST) / Metformin (LT) (B)
Metformin (open-label)Tablets, Oral, 500-1500 mg, as needed (starting in LT)	Drug	Placebo (ST) / Metformin (LT) (B)

Primary outcome

Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Time frame: Baseline, Week 12
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

1 secondary outcome

Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 21 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin 5 mg	20	17
Placebo / Metformin	16	15

Primary outcome: Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12

Time frame: Baseline, Week 12. Geometric mean (95% Confidence Interval). Unit: Percent Change (Percentage of Baseline)

Measure	Short Term Period: Saxagliptin 5 mg n = 16	Short Term Period: Placebo n = 15
Value	15.9 (4.2 to 29.0)	-2.2 (-12.4 to 9.3)

Short Term Period: Saxagliptin 5 mg vs Short Term Period: Placebo: Adjusted Percent Difference: 18.5 (95% CI 1.3 to 38.7), p = 0.0350, ANCOVA

Population analysed: Randomized participants with both a baseline and post-baseline value (up to Week 12).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Short term period (up to 12 weeks) + long term period (up to 104 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLACEBO/METFORMIN	2 of 16 (12.5%)	14 of 16 (87.5%)	Not reported
SAXAGLIPTIN 5 MG	1 of 20 (5%)	17 of 20 (85%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, Metformin (blinded) and Metformin (open-label) in people with Type 2 Diabetes, run by AstraZeneca at 3 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 2 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 7 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 3 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 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 21 Jan 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?

Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 (time frame: Baseline, Week 12). 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 NCT00374907.

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 7 May 2015.