Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 74 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 572 participants
Where: 74 sitesin 14 countries
Study dates: Jan 2008to Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with type 2 diabetes
Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
HbA1c ≥7.0% and ≤11.0%

Who cannot join

Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.

Trial locations and contacts

74 sites in 14 countries.

Country

City, postcode or hospital

74 sites in 14 countries

Poland13 sites

Research Site
Bialystok
Research Site
Ciechanów
Research Site
Golub-Dobrzyń
Research Site
Grodzisk Mazowiecki
Research Site
Katowice
Research Site
Krakow
Research Site
Lodz, 90-153
Research Site
Maków Mazowiecki
Research Site
Radom
Research Site
Szczecin
Research Site
Warsaw
Research Site
Wroclaw
Research Site
Zabrze

Other trials in Poland

United States11 sites

Research Site
Baltimore, Maryland
Research Site
Charleston, West Virginia
Research Site
Cincinnati, Ohio
Research Site
Concord, California
Research Site
Corpus Christi, Texas
Research Site
Denver, Colorado
Research Site
Great Falls, Montana
Research Site
Greenville, North Carolina
Research Site
Morehead City, North Carolina
Research Site
Sacramento, California
Research Site
Topeka, Kansas

Other trials in United States

Ukraine8 sites

Research Site
Dnipropetrovsk
Research Site
Ivano-Frankivsk
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Mykolayiv
Research Site
Sumy
Research Site
Ternopil
Research Site
Zaporizhzhya

Other trials in Ukraine

Croatia5 sites

Research Site
Karlovac
Research Site
Osijek
Research Site
Rijeka, Croatia
Research Site
Split
Research Site
Zagreb

Other trials in Croatia

Czechia5 sites

Research Site
Moravský Krumlov
Research Site
Prague
Research Site
Teplice
Research Site
Ústí nad Labem
Research Site
Znojmo

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Germany5 sites

Research Site
Dieburg
Research Site
Düsseldorf
Research Site
Hanover
Research Site
Heidelberg
Research Site
Mannheim

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Hungary5 sites

Research Site
Debrecen
Research Site
Győr
Research Site
Kalocsa
Research Site
Kecskemét
Research Site
Zalaegerszeg

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Romania5 sites

Research Site
Bacau, Bacău
Research Site
Brasov, Brașov County
Research Site
Bucharest
Research Site
Satu Mare, Satu Mare County
Research Site
Sf Gheorghe

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Russia5 sites

Research Site
Chelyabinsk
Research Site
Moscow
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Yaroslavl

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Lithuania4 sites

Research Site
Kaunas
Research Site
Klaipėda
Research Site
Panevezys
Research Site
Vilnius

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Belarus3 sites

Research Site
Brest
Research Site
Homyel
Research Site
Minsk

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Bulgaria3 sites

Research Site
Dimitrovgrad
Research Site
Sofia
Research Site
Veliko Tarnovo

Other trials in Bulgaria

Estonia1 site

Research Site
Tallinn

Other trials in Estonia

Latvia1 site

Research Site
Riga

Other trials in Latvia

About this study

Official title: A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Placebo
Keywords: DPP-4 inhibitors, HbA1c, incretins, Renal Impairment
Medical subject headings: Diabetes Mellitus, Type 2, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaxagliptinDrug
Also called Onglyza
2.5 mg once daily oral dose
PlaceboDrug
Placebo

Study groups in NCT00614939
Study group	Role	What they receive
Saxa	Experimental	Saxagliptin Receives: Drug: Saxagliptin
Placebo	No intervention	Placebo to match Receives: Drug: Placebo

What is being measured

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

Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Measured: Baseline , Week 12 (LOCF)

Secondary outcomes (9)

Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Measured: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Measured: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Measured: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Measured: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
Measured: Baseline , Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
Measured: Baseline, Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
Measured: Baseline, Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
Measured: Baseline, Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value
Measured: Baseline, Week 52

Timeline

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

Jan 2008Mar 2010

First posted13 Feb 2008 (estimated)
Study startJan 2008
Primary completionJun 2009
Study completionMar 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.
Publications (1)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00614939
Sponsor's protocol ID: D1680C00007
Other IDs: EudraCT number 2007-004951-12
Status last verified: May 2011
First submitted: 31 Jan 2008
Last updated: 19 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011 Jun;13(6):523-32. doi: 10.1111/j.1463-1326.2011.01382.x.
PubMed 21332627

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
ClinicalTrials.gov ID: NCT00614939
Acronym / sponsor ID: D1680C00007
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors, HbA1c, incretins, Renal Impairment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 572 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Jan 2008
Primary completion: Jun 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Posted 7 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

Study design

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

Arm	Type	Receives
Saxa	Experimental	Drug: SaxagliptinSaxagliptin
Placebo	No intervention	Drug: PlaceboPlacebo to match

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosed with type 2 diabetes
Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
HbA1c ≥7.0% and ≤11.0%

Key exclusion criteria (2 listed)

Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.

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: Onglyza2.5 mg once daily oral dose	Drug	Saxa
PlaceboPlacebo	Drug	Placebo

Primary outcome

Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
Time frame: Baseline , Week 12 (LOCF)
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

9 secondary outcomes

Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup
Time frame: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup
Time frame: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup
Time frame: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup
Time frame: Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
Time frame: Baseline , Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
Time frame: Baseline, Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup
Time frame: Baseline, Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup
Time frame: Baseline, Week 52
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
Time frame: Baseline, Week 52

Results and safety

Results posted to the registry on 7 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	85	50
Saxa	85	42

Primary outcome: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)

Time frame: Baseline , Week 12 (LOCF). Mean (Standard Error). Unit: Percent

Measure	Placebo n = 83	Saxa n = 81
Baseline	8.09 (0.119)	8.45 (0.135)
Week 12	7.80 (0.137)	7.63 (0.132)
Adjusted Mean Change from Baseline	-0.44 (0.109)	-0.86 (0.112)

Placebo vs Saxa: Mean Difference (Net): -0.42 (95% CI -0.71 to -0.12), p = 0.007, ANCOVA

Population analysed: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	24 of 85 (28.2%)	36 of 85 (42.4%)	Not reported
Saxa	23 of 85 (27.1%)	38 of 85 (44.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21332627Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011 Jun;13(6):523-32. doi: 10.1111/j.1463-1326.2011.01382.x.

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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.

Peter Ohman, MD, PhD study director

AstraZeneca

Deborah Price, MSc study chair

AstraZeneca

74 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 74 sites in 14 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 3 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Poland, United States, Ukraine, Croatia, Czechia and 9 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. 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 7 Jul 2010). 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?

Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) (time frame: Baseline , Week 12 (LOCF)). 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 NCT00614939, which also lists 1 linked publication.

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 19 May 2011.